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

Last updated: August 26, 2020
Sponsor: University of Sao Paulo
Overall Status: Active - Recruiting

Phase

1

Condition

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT04168125
Ceap
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Total Participants: 30
Study Start date:
September 26, 2019
Estimated Completion Date:
March 24, 2021

Study 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.

Connect with a study center

  • Bauru School of Dentistry

    Bauru, 17012-901
    Brazil

    Active - Recruiting

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