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Photobiomodulation in Palate Wounds: Somatosensorial Evaluation

Primary Purpose

Surgical Wound

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Photobiomodulation
Protection with surgical dressing
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Palate with normal and healthy mucosa Patient with indication of gingival graft surgery Exclusion Criteria: Patients using prosthesis with palate coverage Former removal of gingival graft in the palate Smokers Pregnancy and breastfeeding mothers Use of anticonvulsants and immunosuppressors

Sites / Locations

  • Bauru School of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Photobiomodulation

Control

Arm Description

Red laser irradiation on palate wound at the day of the surgery and after 2, 4 and 6 days postoperatively. Protection of wound with surgical dressing during 7 days.

Protection of wound with surgical dressing during 7 days.

Outcomes

Primary Outcome Measures

Somatosensory recovery
Mechanical and pain detection threshold measured with Von Frey filaments

Secondary Outcome Measures

Assessment of Pain
Numeric analogue scale from zero to ten. Patients marks zero for no pain and ten for the worse pain.
Measurement of Quality of life
Patients fill the Oral Health Impact Profile (OHIP-14) questionnaire. It comprises 14 questions about oral health problems. In each question the patient may answer if they he have those problems very often (coded 4), fairly often (coded 3), occasionally (coded 2), hardly ever (coded 1) or never (coded 0). Questionnaire scale ranges from 0 to 56 with higher scores indicating poorer quality of life.

Full Information

First Posted
September 25, 2023
Last Updated
October 2, 2023
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT06073678
Brief Title
Photobiomodulation in Palate Wounds: Somatosensorial Evaluation
Official Title
Photobiomodulation in Gingival Graft Donor Areas: Clinical, Somatosensory, and Quality of Life Evaluations
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
December 23, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to compare the effects of photobiomodulation with red laser on gingival graft donor areas of the palate in comparison to only protection with wound dressing. The main questions it aims to answer are: Does photobiomodulation on the palate promote faster somatosensory recovery? Does photobiomodulation reduce pain in palate donor sites, improving the quality of life? Participants who need gingival graft surgeries will receive laser irradiation on the palate donor area or just protection with wound dressing. Data will be collected up to 60 days. Researchers will compare protection on the palate and protection plus laser irradiation to see if laser therapy may reduce pain and accelerate somatosensory normalization. Moreover, they will measure changes in the quality of life after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Patients will be masked by using a sham laser. Outcomes assessor will not be able to identify the experimental groups
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Photobiomodulation
Arm Type
Experimental
Arm Description
Red laser irradiation on palate wound at the day of the surgery and after 2, 4 and 6 days postoperatively. Protection of wound with surgical dressing during 7 days.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Protection of wound with surgical dressing during 7 days.
Intervention Type
Other
Intervention Name(s)
Photobiomodulation
Other Intervention Name(s)
Low level laser treatment, Low intensity laser treatment
Intervention Description
Irradiation with red laser on palate wound each 48h for 4 sessions.
Intervention Type
Other
Intervention Name(s)
Protection with surgical dressing
Other Intervention Name(s)
Protection of wound
Intervention Description
Protection of the palatal wound with surgical dressing for 7 days
Primary Outcome Measure Information:
Title
Somatosensory recovery
Description
Mechanical and pain detection threshold measured with Von Frey filaments
Time Frame
30 and 60 days postoperatively
Secondary Outcome Measure Information:
Title
Assessment of Pain
Description
Numeric analogue scale from zero to ten. Patients marks zero for no pain and ten for the worse pain.
Time Frame
24 hours, 3 days, 7 days and 14 days
Title
Measurement of Quality of life
Description
Patients fill the Oral Health Impact Profile (OHIP-14) questionnaire. It comprises 14 questions about oral health problems. In each question the patient may answer if they he have those problems very often (coded 4), fairly often (coded 3), occasionally (coded 2), hardly ever (coded 1) or never (coded 0). Questionnaire scale ranges from 0 to 56 with higher scores indicating poorer quality of life.
Time Frame
Baseline, 7 days and 14 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Palate with normal and healthy mucosa Patient with indication of gingival graft surgery Exclusion Criteria: Patients using prosthesis with palate coverage Former removal of gingival graft in the palate Smokers Pregnancy and breastfeeding mothers Use of anticonvulsants and immunosuppressors
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla Damante, PhD
Phone
+55 14 32358366
Email
cdamante@usp.br
Facility Information:
Facility Name
Bauru School of Dentistry
City
Bauru
State/Province
São Paulo
ZIP/Postal Code
17012-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Damante, PhD
Phone
+55 14 32266064
Email
cdamante@usp.br
First Name & Middle Initial & Last Name & Degree
Isadora Gasparoto, MD
Phone
+55 14 32358366
Email
isadoramgasparoto@usp.br
First Name & Middle Initial & Last Name & Degree
Carla Damante, PhD
First Name & Middle Initial & Last Name & Degree
Isadora Gasparoto, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32613416
Citation
Zhao H, Hu J, Zhao L. The effect of low-level laser therapy as an adjunct to periodontal surgery in the management of postoperative pain and wound healing: a systematic review and meta-analysis. Lasers Med Sci. 2021 Feb;36(1):175-187. doi: 10.1007/s10103-020-03072-5. Epub 2020 Jul 1.
Results Reference
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PubMed Identifier
25373688
Citation
Dias SB, Fonseca MV, Dos Santos NC, Mathias IF, Martinho FC, Junior MS, Jardini MA, Santamaria MP. Effect of GaAIAs low-level laser therapy on the healing of human palate mucosa after connective tissue graft harvesting: randomized clinical trial. Lasers Med Sci. 2015 Aug;30(6):1695-702. doi: 10.1007/s10103-014-1685-2. Epub 2014 Nov 6.
Results Reference
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Photobiomodulation in Palate Wounds: Somatosensorial Evaluation

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