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

NCT ID: NCT04168125

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-26
• Study Completion Date: 2020-03-02

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.

Conditions

Pain, Postoperative; Palate; Wound; Cicatrization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tilapia skin

Intervention Type: DEVICE

Application tilapia skin as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.

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.

Group Type: ACTIVE_COMPARATOR

Surgical Wound Dressing

Intervention Type: DEVICE

Application surgical wound dressing as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.

Interventions

Tilapia skin

Application tilapia skin as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.

Intervention Type: DEVICE

Surgical Wound Dressing

Application surgical wound dressing as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Gustavo Gonçalves do Prado Manfredi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adriana CP Sant'Ana, PhD

Role: STUDY_DIRECTOR

Bauru School of Dentistry - University of Sao Paulo

Locations

Bauru School of Dentistry

Bauru, Brazil, Brazil

Countries

Brazil

Other Identifiers

Ceap

Identifier Type: -

Identifier Source: org_study_id