Use of Tilapia Skin for Palate Repair and Protection After Graft Removal

Randomised Clinical Study to evaluate the efficacy of tilapia skin as an occlusive biological dressing on palatal wound healing after free gingival graft harvesting.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Palate; Wound; Cicatrization
• Intervention / Treatment: Device: Tilapia skin; Device: Surgical Wound Dressing

Detailed Description

Autogenous grafts are currently considered the gold standard in regenerative and reconstructive procedures. However, these procedures require a second surgical site to provide the tissue graft. In autogenous gingival grafts, the area commonly selected for graft harvesting is the palate, which is linked to great discomfort and morbidity for the patient. In order to overcome these limitations, xenogeneic and alloplastic materials have been tested as tissue substitutes, but their results are still considerably inferior when compared to autogenous grafts. Faced with this superiority, another approach to favor the use of autogenous grafting is to develop materials that provide greater postoperative comfort and patient safety. Since the main complaint arising from the technique is related to pain resulting from the remaining surgical wound on the palate, it is interesting to look for mechanisms to reduce this sensitivity and accelerate the healing process. For this, the use of tilapia skin as a postoperative dressing seems to be a good alternative. Thus, the purpose of this study is to evaluate the use of tilapia skin, with the intention of accelerating the palate healing process, and to serve as a protector barrier during the healing process. Patients treated according to two techniques for palate protection after autogenous gingival graft harvesting will be evaluated: C- use of surgical cement and T- use of tilapia skin. Will be selected 60 patients of both sexes,> 18 years old, requiring the removal of the palate graft for periodontal surgery. At the time of graft removal, palate thickness and graft dimensions will be measured. After 7, 14 and 30 days, the patient's discomfort and the difficulty in chewing and speaking will be recorded through a visual analog scale, the consumption of analgesic, and the dimensions of the surgical wound on the palate. For statistical analysis, two-way ANOVA will be performed and t-test paired on the obtained results.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Gustavo GP Manfredi, MSc; Phone Number: +5518981711825; Email: gustavo.manfredi@usp.br

Study Locations

• Brazil
  • Bauru, Brazil, 17012-901
    • Recruiting
    • Bauru School of Dentistry
    • Contact: Gustavo Gonçalves do P Manfredi, MSc; Phone Number: 18981711825

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients need periodontal or peri-implant surgical procedures requiring palate gingival graft

Exclusion Criteria:

• Patients with an infectious condition that compromises the procedures
• Users of drugs that can act on periodontal tissues or the healing process
• Pregnant
• Smokers
• Diabetes
• Irradiated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tilapia skin; Procedure/Surgery: Free gingival graft harvesting from hard palate. After gingival graft harvesting from hard palate, it will be placed a tilapia skin as an occlusive biological dressing for palatal wound healing. Device: Tilapia skin. A xenogeneic collagen dressing will be placed over palate wound and stabilized with sutures during the healing process.	Device: Tilapia skin; Application tilapia skin as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.
Active Comparator: Surgical Wound Dressing; Procedure/Surgery: Free gingival graft harvesting from hard palate. After gingival graft harvesting from hard palate, it will be placed a surgical wound dressing as a mechanical protection during palatal wound healing. Device: Surgical wound dressing A surgical wound dressing will be placed over palate wound during the healing process to provide mechanical protection.	Device: Surgical Wound Dressing; Application surgical wound dressing as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported pain perception evaluated by a visual analog scale	Patient's self-reported pain perception will be evaluated using a visual analog scale with a score ranging from 0 (no pain) to 10 (unbearable pain).	14 days after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported discomfort evaluated by a visual analog scale	Patient's self-reported discomfort will be evaluated using a visual analog scale with a score ranging from 0 (no discomfort) to 2 (high discomfort).	14 days after the surgery
Self-reported trouble with speech evaluated by a visual analog scale	Patient's self-reported trouble with speech will be evaluated using a visual analog scale with a score ranging from 0 (no trouble) to 2 (high trouble).	14 days after the surgery
Self-reported trouble with eating evaluated by a visual analog scale	Patient's self-reported trouble with eating will be evaluated using a visual analog scale with a score ranging from 0 (no trouble) to 2 (high trouble).	14 days after the surgery
Comparison of the palate healing process evaluated through linear measurements (millimiter)	Pictures will be taken immediately after the gingival graft harvesting and compared with post-operativa pictures through the use of linear measurements at Image J.	30 days after the surgery
Number of analgesic pills taken after surgery	Evaluate the patient's perception of postoperative pain and discomfort by counting the number of analgesic pills taken after the surgery.	14 days after the surgery

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Director: Adriana CP Sant'Ana, PhD, Bauru School of Dentistry - University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Anticipated): November 23, 2020
• Study Completion (Anticipated): March 24, 2021

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: November 17, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Fibrosis; Pain, Postoperative; Cicatrix
• Other Study ID Numbers: Ceap

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No