Trial Outcomes & Findings for Comparison of Two Different Low-level Laser Intensity Protocols on the Healing of Palatal Wounds (NCT NCT02580357)
NCT ID: NCT02580357
Last Updated: 2017-05-08
Results Overview
For this, standardized photographs were taken (brightness, distance and angle). A scale was used as a reference to measure this area. These photographs were exported to image software ( Image J - NIH, Bethesda, USA) and remaining wound area was measured in square millimeters (mm²).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
7,14, 45 and 60 post operative days
Results posted on
2017-05-08
Participant Flow
At clinical site
Participant milestones
| Measure |
Low Level Laser Therapy (LLLT) Sham
The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
|
GaAlAs Laser Therapy (LLLT) 60 J/cm²
The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
|
GaAlAs Laser Therapy (LLLT) 30 J/cm²
The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
18
|
|
Overall Study
COMPLETED
|
15
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Low Level Laser Therapy (LLLT) Sham
The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
|
GaAlAs Laser Therapy (LLLT) 60 J/cm²
The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
|
GaAlAs Laser Therapy (LLLT) 30 J/cm²
The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
Comparison of Two Different Low-level Laser Intensity Protocols on the Healing of Palatal Wounds
Baseline characteristics by cohort
| Measure |
Low Level Laser Therapy (LLLT) Sham
n=15 Participants
The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
|
GaAlAs Laser Therapy (LLLT) 60 J/cm²
n=18 Participants
The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
|
GaAlAs Laser Therapy (LLLT) 30 J/cm²
n=18 Participants
The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
40.01 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
47 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
43.4 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
18 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
Remaining wound area (RWA-mm2 )
|
62.91 square millimeters
STANDARD_DEVIATION 23.27 • n=5 Participants
|
50.15 square millimeters
STANDARD_DEVIATION 18.49 • n=7 Participants
|
65.74 square millimeters
STANDARD_DEVIATION 25.08 • n=5 Participants
|
59.6 square millimeters
STANDARD_DEVIATION 22.28 • n=4 Participants
|
PRIMARY outcome
Timeframe: 7,14, 45 and 60 post operative daysFor this, standardized photographs were taken (brightness, distance and angle). A scale was used as a reference to measure this area. These photographs were exported to image software ( Image J - NIH, Bethesda, USA) and remaining wound area was measured in square millimeters (mm²).
Outcome measures
| Measure |
Low Level Laser Therapy (LLLT) Sham
n=60 Photographs
The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
|
GaAlAs Laser Therapy (LLLT) 60 J/cm²
n=72 Photographs
The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
|
GaAlAs Laser Therapy (LLLT) 30 J/cm²
n=72 Photographs
The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
|
|---|---|---|---|
|
Change in the Remaining Wound Area (RWA)
RWA 7 days
|
62.91 Square millimeters
Standard Deviation 23.27
|
50.15 Square millimeters
Standard Deviation 18.49
|
65.74 Square millimeters
Standard Deviation 25.08
|
|
Change in the Remaining Wound Area (RWA)
RWA 14 days
|
29.86 Square millimeters
Standard Deviation 21.84
|
28.38 Square millimeters
Standard Deviation 13.89
|
27.67 Square millimeters
Standard Deviation 16.16
|
|
Change in the Remaining Wound Area (RWA)
RWA 45 days
|
6.63 Square millimeters
Standard Deviation 11.85
|
8.17 Square millimeters
Standard Deviation 6.66
|
7.45 Square millimeters
Standard Deviation 7.93
|
|
Change in the Remaining Wound Area (RWA)
RWA 60 days
|
5.52 Square millimeters
Standard Deviation 9.37
|
2.33 Square millimeters
Standard Deviation 2.95
|
3.08 Square millimeters
Standard Deviation 2.96
|
SECONDARY outcome
Timeframe: 7, 14, 45, and 60 days after surgical procedureAfter air jet application, patients were requested to score postoperative discomfort through on a visual analogue scale (VAS) of 10 centimeters, in which 0 meant "no pain" and 10 meant "extreme pain". After this, a postoperative discomfort average for all groups was obtained.
Outcome measures
| Measure |
Low Level Laser Therapy (LLLT) Sham
n=15 Participants
The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
|
GaAlAs Laser Therapy (LLLT) 60 J/cm²
n=18 Participants
The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
|
GaAlAs Laser Therapy (LLLT) 30 J/cm²
n=18 Participants
The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.
Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.
GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site.
|
|---|---|---|---|
|
Postoperative Discomfort
Pain 7 days
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
|
Postoperative Discomfort
Pain 14 days
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
|
Postoperative Discomfort
Pain 45 days
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
|
Postoperative Discomfort
Pain 60 days
|
0 units on a scale
Standard Deviation 0
|
0.056 units on a scale
Standard Deviation 0.23
|
0 units on a scale
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before the procedure and 3 months after the procedureThrough four fixed points marked 5 and 7 mm from the gingival margin in the operated region, tissue thickness of palatine masticatory mucosa. One stent was made to standardize the points to be measured. The stent was positioned, and with a periodontal probe and the points were marked. Then the stent was removed and measurements were taken. For this, an endodontic spacer with a rubber cursor was put on the marked points for it to reach the palatine bone plate. Then the cursor was taken to the tissue carefully to not pressuring it. The distance between the spacer tip and the cursor was measured using a digital pachymeter and measured in millimeters (mm).
Outcome measures
Outcome data not reported
Adverse Events
Low Level Laser Therapy (LLLT) Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GaAlAs Laser Therapy (LLLT) 60 J/cm²
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GaAlAs Laser Therapy (LLLT) 30 J/cm²
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mauro P. Santamaria
Institute of Science and Technology of São José dos Campos (Unesp)
Phone: +55 (16) 981937777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place