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Trial Outcomes & Findings for Effects of Laser Stimulation on Wound Healing of Human Palatal Tissue (NCT NCT03741062)

NCT ID: NCT03741062

Last Updated: 2020-11-10

Results Overview

At the end of their surgical appointment, patients will be given a Visual Analogue Scale (VAS) questionnaire to rate their post-operative pain by making a mark along a 10-cm line (0 = no pain, 10 = unbearable pain) for each night of the first post-operative week. At the one-week post-operative appointment, the participants will return their VAS questionnaires and their reported post-operative discomfort for each night of the initial post-operative week will be tabulated.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

One week

Results posted on

2020-11-10

Participant Flow

Participant milestones

Participant milestones
Measure
J. Morita AdvErl Evo Er:YAG Laser
Immediately following completion of the surgical procedure, this group will receive photobiomodulation treatment of the palatal tissue donor site with Er:YAG laser according to the parameters recommended by experts in this field and which have shown to induce maximal proliferation of human gingival fibroblasts (Fluence: 6.3 J/cm2, Energy Setting: 80 mJ, Pulse Rate: 25 Hz, Duration: 30 s). J. Morita AdvErl Evo Er:YAG laser: Er:YAG laser perimeters: Fluence = 6.3 J/cm\^2 Energy = 80 mJ Pulse Rate = 25 Hz Duration = 30 s
Control
This group will receive sham treatment of the palatal tissue donor site. The laser unit will be turned off. The clinician will simulate usage of the Er:YAG laser in a manner that is indistinguishable to the patient from the experimental group. Control: Sham treatment with laser unit turned off
Overall Study
STARTED
5
6
Overall Study
COMPLETED
4
6
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
J. Morita AdvErl Evo Er:YAG Laser
Immediately following completion of the surgical procedure, this group will receive photobiomodulation treatment of the palatal tissue donor site with Er:YAG laser according to the parameters recommended by experts in this field and which have shown to induce maximal proliferation of human gingival fibroblasts (Fluence: 6.3 J/cm2, Energy Setting: 80 mJ, Pulse Rate: 25 Hz, Duration: 30 s). J. Morita AdvErl Evo Er:YAG laser: Er:YAG laser perimeters: Fluence = 6.3 J/cm\^2 Energy = 80 mJ Pulse Rate = 25 Hz Duration = 30 s
Control
This group will receive sham treatment of the palatal tissue donor site. The laser unit will be turned off. The clinician will simulate usage of the Er:YAG laser in a manner that is indistinguishable to the patient from the experimental group. Control: Sham treatment with laser unit turned off
Overall Study
Protocol Violation
1
0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
J. Morita AdvErl Evo Er:YAG Laser
n=4 Participants
Immediately following completion of the surgical procedure, this group will receive photobiomodulation treatment of the palatal tissue donor site with Er:YAG laser according to the parameters recommended by experts in this field and which have shown to induce maximal proliferation of human gingival fibroblasts (Fluence: 6.3 J/cm2, Energy Setting: 80 mJ, Pulse Rate: 25 Hz, Duration: 30 s). J. Morita AdvErl Evo Er:YAG laser: Er:YAG laser perimeters: Fluence = 6.3 J/cm\^2 Energy = 80 mJ Pulse Rate = 25 Hz Duration = 30 s
Control
n=6 Participants
This group will receive sham treatment of the palatal tissue donor site. The laser unit will be turned off. The clinician will simulate usage of the Er:YAG laser in a manner that is indistinguishable to the patient from the experimental group. Control: Sham treatment with laser unit turned off
Total
n=10 Participants
Total of all reporting groups
Age, Continuous
58.5 years
n=4 Participants
62.3 years
n=6 Participants
60.8 years
n=10 Participants
Sex: Female, Male
Female
4 Participants
n=4 Participants
3 Participants
n=6 Participants
7 Participants
n=10 Participants
Sex: Female, Male
Male
0 Participants
n=4 Participants
3 Participants
n=6 Participants
3 Participants
n=10 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Canada
4 Participants
n=4 Participants
6 Participants
n=6 Participants
10 Participants
n=10 Participants

PRIMARY outcome

Timeframe: One week

At the end of their surgical appointment, patients will be given a Visual Analogue Scale (VAS) questionnaire to rate their post-operative pain by making a mark along a 10-cm line (0 = no pain, 10 = unbearable pain) for each night of the first post-operative week. At the one-week post-operative appointment, the participants will return their VAS questionnaires and their reported post-operative discomfort for each night of the initial post-operative week will be tabulated.

Outcome measures

Outcome measures
Measure
J. Morita AdvErl Evo Er:YAG Laser
n=4 Participants
Immediately following completion of the surgical procedure, this group will receive photobiomodulation treatment of the palatal tissue donor site with Er:YAG laser according to the parameters recommended by experts in this field and which have shown to induce maximal proliferation of human gingival fibroblasts (Fluence: 6.3 J/cm2, Energy Setting: 80 mJ, Pulse Rate: 25 Hz, Duration: 30 s). J. Morita AdvErl Evo Er:YAG laser: Er:YAG laser perimeters: Fluence = 6.3 J/cm\^2 Energy = 80 mJ Pulse Rate = 25 Hz Duration = 30 s
Control
n=6 Participants
This group will receive sham treatment of the palatal tissue donor site. The laser unit will be turned off. The clinician will simulate usage of the Er:YAG laser in a manner that is indistinguishable to the patient from the experimental group. Control: Sham treatment with laser unit turned off
Self-Reported Patient Discomfort as Assessed by a Visual Analogue Scale
Day 4
2.75 score on a scale
Interval 0.2 to 7.0
0.40 score on a scale
Interval 0.0 to 1.5
Self-Reported Patient Discomfort as Assessed by a Visual Analogue Scale
Day 5
2.65 score on a scale
Interval 0.2 to 7.0
0.32 score on a scale
Interval 0.0 to 1.2
Self-Reported Patient Discomfort as Assessed by a Visual Analogue Scale
Day 1
4.90 score on a scale
Interval 0.2 to 9.0
2.45 score on a scale
Interval 0.0 to 9.3
Self-Reported Patient Discomfort as Assessed by a Visual Analogue Scale
Day 2
3.30 score on a scale
Interval 0.1 to 8.0
0.83 score on a scale
Interval 0.0 to 4.3
Self-Reported Patient Discomfort as Assessed by a Visual Analogue Scale
Day 3
2.93 score on a scale
Interval 0.1 to 8.0
0.72 score on a scale
Interval 0.0 to 3.5
Self-Reported Patient Discomfort as Assessed by a Visual Analogue Scale
Day 6
2.65 score on a scale
Interval 0.2 to 6.0
0.16 score on a scale
Interval 0.0 to 0.5

PRIMARY outcome

Timeframe: One week

At the end of their surgical appointment, patients will be provided with a bag of 30 200-mg Ibuprofen tablets. At the one-week post-operative appointment, the participants will return any remaining Ibuprofen tablets and their total analgesic consumption for the initial post-operative week will be tabulated.

Outcome measures

Outcome measures
Measure
J. Morita AdvErl Evo Er:YAG Laser
n=4 Participants
Immediately following completion of the surgical procedure, this group will receive photobiomodulation treatment of the palatal tissue donor site with Er:YAG laser according to the parameters recommended by experts in this field and which have shown to induce maximal proliferation of human gingival fibroblasts (Fluence: 6.3 J/cm2, Energy Setting: 80 mJ, Pulse Rate: 25 Hz, Duration: 30 s). J. Morita AdvErl Evo Er:YAG laser: Er:YAG laser perimeters: Fluence = 6.3 J/cm\^2 Energy = 80 mJ Pulse Rate = 25 Hz Duration = 30 s
Control
n=6 Participants
This group will receive sham treatment of the palatal tissue donor site. The laser unit will be turned off. The clinician will simulate usage of the Er:YAG laser in a manner that is indistinguishable to the patient from the experimental group. Control: Sham treatment with laser unit turned off
Patient Discomfort as Assessed by Analgesic Consumption
10.5 analgesic tablets
Interval 1.0 to 23.0
6.0 analgesic tablets
Interval 0.0 to 16.0

PRIMARY outcome

Timeframe: One Week

At the one-week post-operative appointment, patients will complete a modified Oral Impacts on Daily Performance (OIDP) questionnaire to assess the effect of the palatal wound on their oral-health related quality of life during the first post-operative week. They will rate the overall frequency of disruptions that the palatal surgical site had on eating, speaking, oral hygiene, light physical work, participation in regular outings, sleeping, relaxing, smiling and laughing, their mood, and interpersonal interactions by making a mark along a 10-cm line (0 = never, 10 = constantly) for first post-operative week. When applicable, they will also rate the overall severity of the disruptions for these same categories by making a mark along a 10-cm line (0 = barely noticeable, 10 = extremely disruptive) for first post-operative week.

Outcome measures

Outcome measures
Measure
J. Morita AdvErl Evo Er:YAG Laser
n=4 Participants
Immediately following completion of the surgical procedure, this group will receive photobiomodulation treatment of the palatal tissue donor site with Er:YAG laser according to the parameters recommended by experts in this field and which have shown to induce maximal proliferation of human gingival fibroblasts (Fluence: 6.3 J/cm2, Energy Setting: 80 mJ, Pulse Rate: 25 Hz, Duration: 30 s). J. Morita AdvErl Evo Er:YAG laser: Er:YAG laser perimeters: Fluence = 6.3 J/cm\^2 Energy = 80 mJ Pulse Rate = 25 Hz Duration = 30 s
Control
n=6 Participants
This group will receive sham treatment of the palatal tissue donor site. The laser unit will be turned off. The clinician will simulate usage of the Er:YAG laser in a manner that is indistinguishable to the patient from the experimental group. Control: Sham treatment with laser unit turned off
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Frequency of Disruptions to Eating Food
7.52 score on a scale
Interval 3.0 to 9.6
3.65 score on a scale
Interval 0.0 to 9.5
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Severity of Disruptions to Eating Food
5.25 score on a scale
Interval 0.1 to 8.2
2.65 score on a scale
Interval 0.1 to 5.3
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Frequency of Disruptions to Speaking
4.73 score on a scale
Interval 0.9 to 7.3
1.87 score on a scale
Interval 0.0 to 9.2
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Severity of Disruptions to Speaking
3.28 score on a scale
Interval 0.1 to 7.4
0.55 score on a scale
Interval 0.0 to 1.5
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Frequency of Disruptions when Performing Oral Hygiene
5.18 score on a scale
Interval 1.0 to 9.1
4.22 score on a scale
Interval 0.0 to 9.7
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Severity of Disruptions when Performing Oral Hygiene
4.40 score on a scale
Interval 0.1 to 8.8
4.98 score on a scale
Interval 0.2 to 9.7
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Frequency of Disruptions when Performing Light Work
1.30 score on a scale
Interval 0.6 to 2.0
0.25 score on a scale
Interval 0.0 to 1.0
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Severity of Disruptions when Performing Light Work
0.90 score on a scale
Interval 0.1 to 1.9
0.35 score on a scale
Interval 0.0 to 1.0
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Frequency of Disruptions when Going Out
2.95 score on a scale
Interval 0.6 to 6.5
0.38 score on a scale
Interval 0.0 to 1.7
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Severity of Disruptions when Going Out
2.55 score on a scale
Interval 0.1 to 6.7
0.58 score on a scale
Interval 0.1 to 1.7
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Frequency of Disruptions While Sleeping
6.20 score on a scale
Interval 4.5 to 8.1
1.62 score on a scale
Interval 0.0 to 5.6
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Severity of Disruptions While Sleeping
3.03 score on a scale
Interval 0.1 to 5.3
2.20 score on a scale
Interval 0.2 to 4.7
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Frequency of Disruptions While Relaxing
4.53 score on a scale
Interval 2.2 to 7.0
0.58 score on a scale
Interval 0.0 to 2.7
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Severity of Disruptions While Relaxing
1.33 score on a scale
Interval 0.1 to 3.2
0.80 score on a scale
Interval 0.1 to 2.5
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Frequency of Disruptions While Smiling and Laughing
7.77 score on a scale
Interval 6.0 to 9.6
2.22 score on a scale
Interval 0.0 to 6.8
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Severity of Disruptions While Smiling and Laughing
4.70 score on a scale
Interval 0.1 to 7.4
3.20 score on a scale
Interval 0.4 to 6.7
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Frequency of Disruptions to Patient's Mood
2.83 score on a scale
Interval 0.3 to 5.0
2.25 score on a scale
Interval 0.0 to 7.6
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Severity of Disruptions to Patient's Mood
1.17 score on a scale
Interval 0.1 to 3.1
3.30 score on a scale
Interval 0.3 to 7.5
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Frequency of Disruptions to Patient's Personal Interactions
4.23 score on a scale
Interval 3.6 to 5.1
1.00 score on a scale
Interval 0.0 to 3.9
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire
Severity of Disruptions to Patient's Personal Interactions
2.90 score on a scale
Interval 0.1 to 5.1
1.43 score on a scale
Interval 0.1 to 3.9

SECONDARY outcome

Timeframe: Six weeks

At a six-week post-operative appointment, a histological specimen will be harvested with a tissue punch. Samples of laser-treated and non laser-treated palatal tissues will be histologically compared with respect to concentration of inflammatory cells, amount of Type I collagen present, and amount of Type III collagen present.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One week, Two weeks

At the one-week and two-week post-operative appointments, a clinician who did not perform the surgery and is blinded to which treatment group the patient belongs will assess the donor site according to the Modified Early-Wound Healing Index (MEHI) proposed by Fickl. The clinician will evaluate the palatal tissue donor site and rate it from 1 to 5 (1 = complete flap closure without fibrin line at the palate, 5 = incomplete flap closure with \>50% necrosis of the palatal flap tissue). The progression of post-operative healing at one week and two weeks will be compared between experimental and control groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One week, Two weeks

At the one-week and two-week post-operative appointments, a clinician who did not perform the surgery and is blinded to which treatment group the patient belongs will assess the donor site according to the Healing Index (HI) proposed by Landry, Turnbull, and Howley. The clinician will evaluate the palatal tissue donor site and rate it from 1 to 5 (1 = very poor, 5 = excellent) based on the parameters of tissue colour, bleeding response to palpation, presence of granulation tissue, presence of suppuration, exposure of underlying connective tissue, and epithelialization along incision margins. The progression of post-operative healing at one week and two weeks will be compared between experimental and control groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Six weeks

At a six-week post-operative appointment, tissue thickness at the donor site will be measured in millimetres via bone sounding with a periodontal probe. This will be compared to pre-operative measurements taken at the site.

Outcome measures

Outcome data not reported

Adverse Events

J. Morita AdvErl Evo Er:YAG Laser

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
J. Morita AdvErl Evo Er:YAG Laser
n=5 participants at risk
Immediately following completion of the surgical procedure, this group will receive photobiomodulation treatment of the palatal tissue donor site with Er:YAG laser according to the parameters recommended by experts in this field and which have shown to induce maximal proliferation of human gingival fibroblasts (Fluence: 6.3 J/cm2, Energy Setting: 80 mJ, Pulse Rate: 25 Hz, Duration: 30 s). J. Morita AdvErl Evo Er:YAG laser: Er:YAG laser perimeters: Fluence = 6.3 J/cm\^2 Energy = 80 mJ Pulse Rate = 25 Hz Duration = 30 s
Control
n=6 participants at risk
This group will receive sham treatment of the palatal tissue donor site. The laser unit will be turned off. The clinician will simulate usage of the Er:YAG laser in a manner that is indistinguishable to the patient from the experimental group. Control: Sham treatment with laser unit turned off
Injury, poisoning and procedural complications
Inadequate Hemostasis at Donor Site
20.0%
1/5 • Number of events 1 • Adverse event data was collected for the 6-week period during which the study was conducted for each patient.
0.00%
0/6 • Adverse event data was collected for the 6-week period during which the study was conducted for each patient.
Injury, poisoning and procedural complications
Hematoma
20.0%
1/5 • Number of events 1 • Adverse event data was collected for the 6-week period during which the study was conducted for each patient.
0.00%
0/6 • Adverse event data was collected for the 6-week period during which the study was conducted for each patient.

Additional Information

Dr. Brian Wiens

University of Manitoba

Phone: 613-809-4501

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place