Trial Outcomes & Findings for LLLT Effects on Inferior Alveolar Nerve (IAN) Recovery Post-orthognathic Surgery (NCT NCT04910074)
NCT ID: NCT04910074
Last Updated: 2025-06-24
Results Overview
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
TERMINATED
NA
25 participants
24 hours post-surgery
2025-06-24
Participant Flow
Participant milestones
| Measure |
Low-level Therapy Intervention
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy (LLLT): The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
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|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low-level Therapy Intervention
n=12 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy (LLLT): The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=13 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=12 Participants
|
3 Participants
n=13 Participants
|
6 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=12 Participants
|
10 Participants
n=13 Participants
|
19 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=25 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=12 Participants
|
9 Participants
n=13 Participants
|
15 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=12 Participants
|
4 Participants
n=13 Participants
|
10 Participants
n=25 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
13 participants
n=13 Participants
|
25 participants
n=25 Participants
|
|
Inferior Alveolar Nerve (IAN) Function for Soft Stimuli
R1
|
12 Participants
n=12 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
10 Participants
n=10 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
22 Participants
n=22 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
|
Inferior Alveolar Nerve (IAN) Function for Soft Stimuli
R2
|
12 Participants
n=12 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
10 Participants
n=10 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
22 Participants
n=22 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
|
Inferior Alveolar Nerve (IAN) Function for Soft Stimuli
R3
|
12 Participants
n=12 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
10 Participants
n=10 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
22 Participants
n=22 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
|
Inferior Alveolar Nerve (IAN) Function for Soft Stimuli
R4
|
12 Participants
n=12 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
10 Participants
n=10 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
22 Participants
n=22 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
|
Inferior Alveolar Nerve (IAN) Function for Soft Stimuli
L1
|
12 Participants
n=12 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
10 Participants
n=10 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
22 Participants
n=22 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
|
Inferior Alveolar Nerve (IAN) Function for Soft Stimuli
L2
|
12 Participants
n=12 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
9 Participants
n=9 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
21 Participants
n=21 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
|
Inferior Alveolar Nerve (IAN) Function for Soft Stimuli
L3
|
12 Participants
n=12 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
9 Participants
n=9 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
21 Participants
n=21 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
|
Inferior Alveolar Nerve (IAN) Function for Soft Stimuli
L4
|
12 Participants
n=12 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
10 Participants
n=10 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
22 Participants
n=22 Participants • Swab samples were only collected from 10 patients in the Sham intervention arm with the exception of region L2 and region L3 samples which were only collected from 9 patients in the Sham intervention arm.
|
|
Inferior Alveolar Nerve (IAN) Function for Hard Stimuli
R1
|
12 Participants
n=12 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
10 Participants
n=10 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
22 Participants
n=22 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
|
Inferior Alveolar Nerve (IAN) Function for Hard Stimuli
R2
|
12 Participants
n=12 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
10 Participants
n=10 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
22 Participants
n=22 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
|
Inferior Alveolar Nerve (IAN) Function for Hard Stimuli
R3
|
12 Participants
n=12 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
10 Participants
n=10 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
22 Participants
n=22 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
|
Inferior Alveolar Nerve (IAN) Function for Hard Stimuli
R4
|
12 Participants
n=12 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
10 Participants
n=10 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
22 Participants
n=22 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
|
Inferior Alveolar Nerve (IAN) Function for Hard Stimuli
L1
|
12 Participants
n=12 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
10 Participants
n=10 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
22 Participants
n=22 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
|
Inferior Alveolar Nerve (IAN) Function for Hard Stimuli
L2
|
12 Participants
n=12 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
10 Participants
n=10 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
22 Participants
n=22 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
|
Inferior Alveolar Nerve (IAN) Function for Hard Stimuli
L3
|
12 Participants
n=12 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
10 Participants
n=10 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
22 Participants
n=22 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
|
Inferior Alveolar Nerve (IAN) Function for Hard Stimuli
L4
|
11 Participants
n=11 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
10 Participants
n=10 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
21 Participants
n=21 Participants • Toothpick samples were collected from all 12 patients in the Low-level therapy intervention arm with the exception of a region L4 sample in one patient. Toothpick samples were only collected from 10 patients in the Sham intervention arm.
|
|
Pre-Operative Pain
Right Side
|
0.4 score on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants • Pain intensity data at baseline was only able to be collected from 5 patients in the Low-level therapy intervention arm and 9 patients in the Sham intervention arm.
|
0.1 score on a scale
STANDARD_DEVIATION 0.3 • n=9 Participants • Pain intensity data at baseline was only able to be collected from 5 patients in the Low-level therapy intervention arm and 9 patients in the Sham intervention arm.
|
0.2 score on a scale
STANDARD_DEVIATION 0.4 • n=14 Participants • Pain intensity data at baseline was only able to be collected from 5 patients in the Low-level therapy intervention arm and 9 patients in the Sham intervention arm.
|
|
Pre-Operative Pain
Left Side
|
0.4 score on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants • Pain intensity data at baseline was only able to be collected from 5 patients in the Low-level therapy intervention arm and 9 patients in the Sham intervention arm.
|
0.1 score on a scale
STANDARD_DEVIATION 0.3 • n=9 Participants • Pain intensity data at baseline was only able to be collected from 5 patients in the Low-level therapy intervention arm and 9 patients in the Sham intervention arm.
|
0.2 score on a scale
STANDARD_DEVIATION 0.4 • n=14 Participants • Pain intensity data at baseline was only able to be collected from 5 patients in the Low-level therapy intervention arm and 9 patients in the Sham intervention arm.
|
|
Pre-Operative Mandibular Swelling
Right Side
|
149 millimeters
STANDARD_DEVIATION 9.91 • n=6 Participants • Pre-operative mandibular swelling was able to be assessed in 6 of 12 patients in the Low-level therapy intervention arm and 8 of 13 patients in the Sham intervention arm.
|
158 millimeters
STANDARD_DEVIATION 14.2 • n=8 Participants • Pre-operative mandibular swelling was able to be assessed in 6 of 12 patients in the Low-level therapy intervention arm and 8 of 13 patients in the Sham intervention arm.
|
153 millimeters
STANDARD_DEVIATION 12.3 • n=14 Participants • Pre-operative mandibular swelling was able to be assessed in 6 of 12 patients in the Low-level therapy intervention arm and 8 of 13 patients in the Sham intervention arm.
|
|
Pre-Operative Mandibular Swelling
Left Side
|
151 millimeters
STANDARD_DEVIATION 9.13 • n=6 Participants • Pre-operative mandibular swelling was able to be assessed in 6 of 12 patients in the Low-level therapy intervention arm and 8 of 13 patients in the Sham intervention arm.
|
160 millimeters
STANDARD_DEVIATION 15.6 • n=8 Participants • Pre-operative mandibular swelling was able to be assessed in 6 of 12 patients in the Low-level therapy intervention arm and 8 of 13 patients in the Sham intervention arm.
|
155 millimeters
STANDARD_DEVIATION 12.6 • n=14 Participants • Pre-operative mandibular swelling was able to be assessed in 6 of 12 patients in the Low-level therapy intervention arm and 8 of 13 patients in the Sham intervention arm.
|
PRIMARY outcome
Timeframe: 24 hours post-surgeryPopulation: 24-hour post-surgical follow-up visits were not conducted during this study. Many patients were still admitted at 24 hours post-procedure and were unable to be brought into the dental clinic. In addition, the instruments and equipment required to conduct this assessment were not available in the hospital in-patient rooms. As a result, cotton swab samples were not obtained from any of the patients at 24 hours post-surgery and there is no IAN function for soft stimuli results data to report.
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 week post-surgeryPopulation: Swab samples were able to be collected from regions R1, R4, L1, and L4 in all 12 patients and from regions R2, R3, L2, and L3 in 11 of 12 patients in the Low-level therapy intervention arm who attended their Week 1 visit. Swab samples were able to be collected from regions R2, R3, L2, and L3 in all 8 patients and from regions R1, R4, L1, and L4 in 7 of 8 patients in the Sham intervention arm who attended their Week 1 visit.
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=12 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=8 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R1
|
10 Participants
|
3 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R2
|
11 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R3
|
11 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R4
|
7 Participants
|
2 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L1
|
8 Participants
|
1 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L2
|
11 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L3
|
11 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L4
|
8 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 2 weeks post-surgeryPopulation: Swab samples were able to be collected from all regions in all 10 patients in the Low-level therapy intervention arm who attended their Week 2 visit. Swab samples were able to be collected from all regions in all 9 patients in the Sham intervention arm with the exception of regions R4 and L4 in which swab samples were able to be collected from 8 of 9 patients who attended their Week 2 visit.
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=10 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=9 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R1
|
8 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R2
|
9 Participants
|
9 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R3
|
10 Participants
|
9 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R4
|
7 Participants
|
5 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L1
|
7 Participants
|
4 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L2
|
10 Participants
|
9 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L3
|
10 Participants
|
9 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L4
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 3 weeks post-surgeryPopulation: Swab samples were able to be collected from all regions in all 10 patients in the Low-level therapy intervention arm and from all regions in all 8 patients in the Sham intervention arm who attended their Week 3 visit.
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=10 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=8 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L2
|
10 Participants
|
7 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L3
|
10 Participants
|
7 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R1
|
7 Participants
|
5 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R2
|
10 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R3
|
10 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R4
|
8 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L1
|
7 Participants
|
3 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L4
|
7 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-surgeryPopulation: Swab samples were able to be collected from all regions in all 8 patients in the Low-level therapy intervention arm and from all regions in all 9 patients in the Sham intervention arm who attended their Week 4 visit.
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=8 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=9 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R1
|
5 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R2
|
8 Participants
|
9 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R3
|
8 Participants
|
9 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R4
|
7 Participants
|
7 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L1
|
4 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L2
|
8 Participants
|
9 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L3
|
8 Participants
|
9 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L4
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 5 weeks post-surgeryPopulation: Swab samples were able to be collected from regions L1 and L4 in all 7 patients and from regions R1, R2, R3, R4, L2, and L3 in 6 of 7 patients in the Low-level therapy intervention arm who attended their Week 5 visit. Swab samples were able to be collected from all regions in all 6 patients in the Sham intervention arm who attended their Week 5 visit.
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=7 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=6 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R1
|
6 Participants
|
3 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R2
|
6 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R3
|
6 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R4
|
6 Participants
|
4 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L1
|
3 Participants
|
4 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L2
|
6 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L3
|
6 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L4
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post-surgeryPopulation: Swab samples were able to be collected from all regions in all 9 patients in the Low-level therapy intervention arm and from all regions in all 8 patients in the Sham intervention arm who attended their Week 6 visit.
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=9 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=8 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R1
|
8 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R2
|
9 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R3
|
9 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R4
|
8 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L1
|
5 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L2
|
9 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L3
|
9 Participants
|
7 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L4
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 8 weeks post-surgeryPopulation: Swab samples were able to be collected from all regions in all 4 patients in the Low-level therapy intervention arm and from all regions in all 5 patients in the Sham intervention arm who attended their Week 8 visit. Due to a deviation one patient in the Sham group had swab samples collected at Week 7 instead of the intended 8-week timepoint.
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=4 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=5 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R1
|
2 Participants
|
4 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R2
|
4 Participants
|
5 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R3
|
4 Participants
|
5 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
R4
|
2 Participants
|
4 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L1
|
3 Participants
|
3 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L2
|
4 Participants
|
5 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L3
|
4 Participants
|
5 Participants
|
|
Inferior Alveolar Nerve Function for Soft Stimuli
L4
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 20 weeks post-surgeryPopulation: Study was terminated in advance of the 20-week timepoint and swab samples were not collected from any of the participants at 20 weeks post-surgery. Accordingly, there are no IAN function for soft stimuli results to report.
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 hours post-surgeryPopulation: 24-hour post-surgical follow-up visits were not conducted during this study. Many patients were still admitted at 24 hours post-procedure and were unable to be brought into the dental clinic. In addition, the instruments and equipment required to conduct this assessment were not available in the hospital in-patient rooms. As a result, toothpick samples were not obtained from any of the patients at 24 hours post-surgery and there is no IAN function for hard stimuli results data to report.
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 week post-surgeryPopulation: Toothpick samples were able to be collected from regions R1, R4, L1, and L4 in all 12 patients and from regions R2, R3, L2, and L3 in 11 of 12 patients in the Low-level therapy intervention arm who attended their Week 1 visit. Toothpick samples were able to be collected from regions R2, R3, L2, and L3 in all 8 patients and from regions R1, R4, L1, and L4 in 7 of 8 patients in the Sham intervention arm who attended their Week 1 visit.
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=12 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=8 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R1
|
10 Participants
|
2 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R2
|
11 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R3
|
11 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R4
|
7 Participants
|
2 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L1
|
8 Participants
|
0 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L2
|
11 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L3
|
11 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L4
|
8 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 2 weeks post-surgeryPopulation: Toothpick samples were able to be collected from all regions in all 10 patients in the Low-level therapy intervention arm who attended their Week 2 visit. Toothpick samples were able to be collected from all regions in all 9 patients in the Sham intervention arm with the exception of region L1 in which toothpick samples were able to be collected from 8 of 9 patients who attended their Week 2 visit.
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=10 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=9 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L1
|
6 Participants
|
5 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L2
|
10 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R1
|
6 Participants
|
5 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R2
|
10 Participants
|
9 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R3
|
10 Participants
|
9 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R4
|
7 Participants
|
5 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L3
|
10 Participants
|
9 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L4
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 3 weeks post-surgeryPopulation: Toothpick samples were able to be collected from all regions in all 10 patients in the Low-level therapy intervention arm and from all regions in all 8 patients in the Sham intervention arm who attended their Week 3 visit.
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=10 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=8 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R2
|
10 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R1
|
9 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R3
|
10 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R4
|
9 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L1
|
9 Participants
|
4 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L2
|
10 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L3
|
10 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L4
|
8 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-surgeryPopulation: Toothpick samples were able to be collected from all regions in all 8 patients in the Low-level therapy intervention arm and from all regions in all 9 patients in the Sham intervention arm who attended their Week 4 visit.
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=8 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=9 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R1
|
5 Participants
|
7 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R2
|
8 Participants
|
9 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R3
|
8 Participants
|
9 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R4
|
7 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L1
|
4 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L2
|
8 Participants
|
9 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L3
|
8 Participants
|
9 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L4
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 5 weeks post-surgeryPopulation: Toothpick samples were able to be collected from regions L1 and L4 in all 7 patients and from regions R1, R2, R3, R4, L2, and L3 in 6 of 7 patients in the Low-level therapy intervention arm who attended their Week 5 visit. Toothpick samples were able to be collected from all regions in all 6 patients in the Sham intervention arm who attended their Week 5 visit.
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=7 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=6 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L4
|
3 Participants
|
3 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R1
|
6 Participants
|
3 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R2
|
6 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R3
|
6 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R4
|
5 Participants
|
3 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L1
|
3 Participants
|
4 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L2
|
6 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L3
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post-surgeryPopulation: Toothpick samples were able to be collected from all regions in all 9 patients in the Low-level therapy intervention arm and from all regions in all 8 patients in the Sham intervention arm who attended their Week 6 visit.
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=9 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=8 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R1
|
8 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R2
|
9 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R3
|
9 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R4
|
9 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L1
|
6 Participants
|
6 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L2
|
9 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L3
|
9 Participants
|
8 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L4
|
5 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 8 weeks post-surgeryPopulation: Toothpick samples were able to be collected from all regions in all 4 patients in the Low-level therapy intervention arm and from all regions in all 5 patients in the Sham intervention arm who attended their Week 8 visit. Due to a deviation one patient in the Sham group had toothpick samples collected at 7 weeks instead of the intended 8-week collection timepoint.
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=4 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=5 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R4
|
2 Participants
|
4 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L3
|
4 Participants
|
5 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R1
|
2 Participants
|
4 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R2
|
4 Participants
|
5 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
R3
|
4 Participants
|
5 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L1
|
3 Participants
|
4 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L2
|
4 Participants
|
5 Participants
|
|
Inferior Alveolar Nerve Function for Hard Stimuli
L4
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 20 weeks post-surgeryPopulation: Study was terminated in advance of the 20-week timepoint and toothpick samples were not collected from any of the participants at 20 weeks post-surgery. Accordingly, there are no IAN function for hard stimuli results to report.
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hours post-surgeryPopulation: 24-hour post-surgical follow-up visits were not conducted during this study. Many patients were still admitted at 24 hours post-procedure and were unable to be brought into the dental clinic. In addition, the instruments and equipment required to conduct this assessment were not available in the hospital in-patient rooms. As a result, VAS scores were not obtained from any of the patients at 24 hours post-surgery and there are no post-operative pain results data to report.
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week post-surgeryPopulation: 1-week post-operative pain (VAS) data was able to be collected from all 12 patients in the Low-level therapy intervention arm and from all 8 patients in the Sham intervention arm who attended their Week 1 visit.
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=12 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=8 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Post-operative Pain
Right Side
|
2.6 score on a scale
Standard Deviation 2.2
|
2.3 score on a scale
Standard Deviation 3.1
|
|
Post-operative Pain
Left Side
|
1.9 score on a scale
Standard Deviation 1.9
|
1.0 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 2 weeks post-surgeryPopulation: 2-week post-operative pain (VAS) data was able to be collected from 9 of 10 patients in the Low-level therapy intervention arm and from all 9 patients in the Sham intervention arm who attended their Week 2 visit.
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=9 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=9 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Post-operative Pain
Right Side
|
1.1 score on a scale
Standard Deviation 1.3
|
1.4 score on a scale
Standard Deviation 2.2
|
|
Post-operative Pain
Left Side
|
1.4 score on a scale
Standard Deviation 2.2
|
0.8 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 3 weeks post-surgeryPopulation: 3-week post-operative pain (VAS) data was able to be collected from 9 of 10 patients in the Low-level therapy intervention arm and from all 8 patients in the Sham intervention arm who attended their Week 3 visit.
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=9 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=8 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Post-operative Pain
Right Side
|
0.9 score on a scale
Standard Deviation 0.8
|
1.5 score on a scale
Standard Deviation 1.8
|
|
Post-operative Pain
Left Side
|
1.3 score on a scale
Standard Deviation 1.7
|
1.3 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 4 weeks post-surgeryPopulation: 4-week post-operative pain (VAS) data was able to be collected from all 8 patients in the Low-level therapy intervention arm and from all 9 patients in the Sham intervention arm who attended their Week 4 visit.
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=8 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=9 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Post-operative Pain
Right Side
|
1.0 score on a scale
Standard Deviation 1.3
|
0.3 score on a scale
Standard Deviation 0.5
|
|
Post-operative Pain
Left Side
|
0.5 score on a scale
Standard Deviation 0.5
|
0.3 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 5 weeks post-surgeryPopulation: 5-week post-operative pain (VAS) data was able to be collected from all 7 patients in the Low-level therapy intervention arm and from all 6 patients in the Sham intervention arm who attended their Week 5 visit.
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=7 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=6 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Post-operative Pain
Right Side
|
0.7 score on a scale
Standard Deviation 0.8
|
0.8 score on a scale
Standard Deviation 1.2
|
|
Post-operative Pain
Left Side
|
0.6 score on a scale
Standard Deviation 0.5
|
0.8 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 6 weeks post-surgeryPopulation: 6-week post-operative pain (VAS) data was able to be collected from all 9 patients in the Low-level therapy intervention arm and from all 8 patients in the Sham intervention arm who attended their Week 6 visit.
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=9 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=8 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Post-operative Pain
Right Side
|
0.3 score on a scale
Standard Deviation 0.5
|
0.5 score on a scale
Standard Deviation 0.5
|
|
Post-operative Pain
Left Side
|
0.3 score on a scale
Standard Deviation 0.5
|
0.4 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 8 weeks post-surgeryPopulation: 8-week post-operative pain (VAS) data was able to be collected from all 4 patients in the Low-level therapy intervention arm and from all 5 patients in the Sham intervention arm who attended their Week 8 visit. Due to a deviation one patient in the Sham group had VAS data collected at 7 weeks instead of the intended 8-week collection timepoint.
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=4 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=5 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Post-operative Pain
Right Side
|
0.5 score on a scale
Standard Deviation 0.6
|
0.2 score on a scale
Standard Deviation 0.4
|
|
Post-operative Pain
Left Side
|
0.5 score on a scale
Standard Deviation 0.6
|
0.2 score on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 20 weeks post-surgeryPopulation: Study was terminated in advance of the 20-week timepoint and the VAS questionnaire was not administered to, nor were data collected from, any of the participants at 20 weeks post-surgery. Accordingly, there are no post-operative pain results to report.
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hours post-surgeryPopulation: 24-hour post-surgical follow-up visits were not conducted during this study. Many patients were still admitted at 24 hours post-procedure and were unable to be brought into the dental clinic. In addition, the instruments and equipment required to conduct this assessment were not available in the hospital in-patient rooms. As a result, mandibular swelling measurements were not obtained from any of the patients at 24 hours post-surgery and there is no mandibular swelling results data to report.
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 week post-surgeryPopulation: 1-week post-operative mandibular swelling data was able to be collected from all 12 patients in the Low-level therapy intervention arm and from all 8 patients in the Sham intervention arm who attended their Week 1 visit.
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=12 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=8 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Post-operative Mandibular Swelling
Right Side
|
153 millimeters
Standard Deviation 12.3
|
138 millimeters
Standard Deviation 23.7
|
|
Post-operative Mandibular Swelling
Left Side
|
156 millimeters
Standard Deviation 16.4
|
133 millimeters
Standard Deviation 25.7
|
SECONDARY outcome
Timeframe: 2 weeks post-surgeryPopulation: 2-week post-operative mandibular swelling data was able to be collected from all 10 patients in the Low-level therapy intervention arm and from all 9 patients in the Sham intervention arm who attended their Week 2 visit.
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=10 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=9 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Post-operative Mandibular Swelling
Right Side
|
154 millimeters
Standard Deviation 18.0
|
140 millimeters
Standard Deviation 18.8
|
|
Post-operative Mandibular Swelling
Left Side
|
152 millimeters
Standard Deviation 23.0
|
132 millimeters
Standard Deviation 27.3
|
SECONDARY outcome
Timeframe: 3 weeks post-surgeryPopulation: 3-week post-operative mandibular swelling data was able to be collected from all 10 patients in the Low-level therapy intervention arm and from 7 of 8 patients in the Sham intervention arm who attended their 3-week visit.
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=10 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=7 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Post-operative Mandibular Swelling
Right Side
|
145 millimeters
Standard Deviation 12.7
|
134 millimeters
Standard Deviation 21.3
|
|
Post-operative Mandibular Swelling
Left Side
|
142 millimeters
Standard Deviation 13.8
|
135 millimeters
Standard Deviation 21.8
|
SECONDARY outcome
Timeframe: 4 weeks post-surgeryPopulation: 4-week post-operative mandibular swelling data was able to be collected from all 8 patients in the Low-level therapy intervention arm and from all 9 patients in the Sham intervention arm who attended their Week 4 visit.
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=8 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=9 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Post-operative Mandibular Swelling
Right Side
|
147 millimeters
Standard Deviation 7.41
|
146 millimeters
Standard Deviation 12.2
|
|
Post-operative Mandibular Swelling
Left Side
|
149 millimeters
Standard Deviation 10.5
|
142 millimeters
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: 5 weeks post-surgeryPopulation: 5-week post-operative mandibular swelling data was able to be collected from all 7 patients in the Low-level therapy intervention arm and from all 6 patients in the Sham intervention arm who attended their Week 5 visit.
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=7 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=6 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Post-operative Mandibular Swelling
Right Side
|
152 millimeters
Standard Deviation 13.1
|
134 millimeters
Standard Deviation 32.0
|
|
Post-operative Mandibular Swelling
Left Side
|
151 millimeters
Standard Deviation 16.0
|
134 millimeters
Standard Deviation 31.1
|
SECONDARY outcome
Timeframe: 6 weeks post-surgeryPopulation: 6-week post-operative mandibular swelling data was able to be collected from all 9 patients in the Low-level therapy intervention arm and from all 8 patients in the Sham intervention arm who attended their Week 6 visit.
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=9 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=8 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Post-operative Mandibular Swelling
Right Side
|
145 millimeters
Standard Deviation 15.2
|
141 millimeters
Standard Deviation 15.0
|
|
Post-operative Mandibular Swelling
Left Side
|
141 millimeters
Standard Deviation 15.8
|
139 millimeters
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: 8 weeks post-surgeryPopulation: 8-week post-operative mandibular swelling data was able to be collected from all 4 patients in the Low-level therapy intervention arm and from all 5 patients in the Sham intervention arm who attended their Week 8 visit. Due to a deviation one patient in the Sham group had Post-operative mandibular swelling data collected at 7 weeks instead of the intended 8-week collection timepoint.
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
Outcome measures
| Measure |
Low-level Therapy Intervention
n=4 Participants
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Low-level laser therapy: The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
Sham Intervention
n=5 Participants
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Sham LLLT: The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
|
|---|---|---|
|
Post-operative Mandibular Swelling
Right Side
|
139 millimeters
Standard Deviation 10.8
|
136 millimeters
Standard Deviation 19.2
|
|
Post-operative Mandibular Swelling
Left Side
|
134 millimeters
Standard Deviation 14.8
|
135 millimeters
Standard Deviation 21.3
|
SECONDARY outcome
Timeframe: 20 weeks post-surgeryPopulation: Study was terminated in advance of the 20-week timepoint and post-operative mandibular swelling measurements were not collected from any of the participants at 20 weeks post-surgery. Accordingly, there are no post-operative mandibular swelling results to report.
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
Outcome measures
Outcome data not reported
Adverse Events
Low-level Therapy Intervention
Sham Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Timothy P. Levine, DMD
Albert Einstein College of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place