NCT04168125

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain, Postoperative
• Palate; Wound
• Cicatrization

Interventions

Type	Name	Description
DEVICE	Tilapia skin	Application tilapia skin as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.
DEVICE	Surgical Wound Dressing	Application surgical wound dressing as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.

Timeline

• Start date: 2019-09-26
• Primary completion: 2020-03-02
• Completion: 2020-03-02
• First posted: 2019-11-19
• Last updated: 2025-04-23

Locations

1 site across 1 country: Brazil