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

Phase 1

Completed

• Conditions: Pain, Postoperative; Cicatrization; Palate; Wound
• Interventions: Device: Surgical Wound Dressing; Device: Tilapia skin

• Registration Number: NCT04168125
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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 Timeline

• Study Start: 2019-09-26
• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-11-17
• Study First Posted: 2019-11-19
• Primary Completion: 2020-03-02
• Study Completion: 2020-03-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical Wound Dressing	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.
Tilapia skin	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.

Primary Outcome Measures

Name	Time	Method
Self-reported pain perception evaluated by a visual analog scale	14 days after the surgery	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).

Secondary Outcome Measures

Name	Time	Method
Self-reported trouble with eating evaluated by a visual analog scale	14 days after the surgery	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).
Number of analgesic pills taken after surgery	14 days after the surgery	Evaluate the patient's perception of postoperative pain and discomfort by counting the number of analgesic pills taken after the surgery.
Self-reported discomfort evaluated by a visual analog scale	14 days after the surgery	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).
Comparison of the palate healing process evaluated through linear measurements (millimiter)	30 days after the surgery	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.
Self-reported trouble with speech evaluated by a visual analog scale	14 days after the surgery	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).

Trial Locations

Locations (1)

Bauru School of Dentistry; 🇧🇷 Bauru, Brazil