Effects of Laser Stimulation on Wound Healing of Human Palatal Tissue

NCT03741062 | Terminated Results FDA Device

• 1 other identifier: B2018:100
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effects of photobiomodulation (PBM) with an Er:YAG laser on the palatal donor site following subepithelial connective tissue graft (SECTG) surgery. Patient-centred outcomes and wound healing will be compared between a control group, who receives no laser treatment, and the test group receiving PBM therapy. It is hypothesized that laser stimulation will have a beneficial effect on the patient's post-operative experience as well as the healing of the tissues.

Conditions

Healing Surgical Wounds; Pain Measurement

Keywords

Laser Therapy; Low-Level Light Therapy; Periodontics; Oral Surgery; Palate; Palate, Hard

Outcome Measures

Primary Outcomes (3)

• Self-Reported Patient Discomfort as Assessed by a Visual Analogue Scale

  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.

  One week

• Patient Discomfort as Assessed by Analgesic Consumption

  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.

  One week

• Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire

  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.

  One Week

Secondary Outcomes (4)

• Healing of the Palatal Donor Site as Assessed by Histological Analysis

  Six weeks

• Healing of the Palatal Donor Site as Assessed by the Modified Early-Wound Healing Index

  One week, Two weeks

• Healing of the Palatal Donor Site as Assessed by the Healing Index

  One week, Two weeks

• Healing of the Palatal Donor Site as Assessed by Tissue Thickness

  Six weeks

Study Arms (2)

J. Morita AdvErl Evo Er:YAG laser

EXPERIMENTAL

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 (Energy Setting: 80 mJ, Pulse Rate: 25 Hz, Duration: 30 s).

Device: J. Morita AdvErl Evo Er:YAG laser

Control

SHAM COMPARATOR

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.

Device: Control

Interventions

J. Morita AdvErl Evo Er:YAG laser DEVICE

Er:YAG laser perimeters: Energy = 80 mJ Pulse Rate = 25 Hz Duration = 30 s

J. Morita AdvErl Evo Er:YAG laser

Control DEVICE

Sham treatment with laser unit turned off

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I or II
• Full Mouth Plaque Score (FMPS) \< 20%
• Full Mouth Bleeding Score (FMBS) \< 20%

You may not qualify if:

• Any contraindications for periodontal surgery,
• Anticoagulant usage
• Corticosteroid usage
• Smoking \> 10 cigarettes/day.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Univerisity of Manitoba, College of Dentistry

Winnipeg, Manitoba, R3E 0W3, Canada

Location

Related Publications (24)

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  BACKGROUND

Limitations and Caveats

Small sample size due to early termination of study because of COVID-19 pandemic. Imbalanced distribution of genders between Control and Treatment groups (despite randomization). Lack of standardization in methods for clinical measurements.

Results Point of Contact

• Title: Dr. Brian Wiens
• Organization: University of Manitoba

wiensb3@myumanitoba.ca

613-809-4501

Study Officials

• Anastasia Cholakis, FRCD(C)

  University of Manitoba

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2018
• First Posted: November 14, 2018
• Study Start: January 24, 2019
• Primary Completion: March 17, 2020
• Study Completion: May 14, 2020
• Last Updated: November 10, 2020
• Results First Posted: November 10, 2020

Record last verified: 2020-10

Locations

CA (1)