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Completed

NCT Number: NCT04168125

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bauru School of Dentistry

Bauru, Brazil, 17012-901

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tilapia skin

Device

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

Surgical Wound Dressing

Device

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

Primary outcomes

  1. Self-reported pain perception evaluated by a visual analog scale

    Time frame: 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 outcomes

  1. Self-reported discomfort evaluated by a visual analog scale

    Time frame: 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).

  2. Self-reported trouble with speech evaluated by a visual analog scale

    Time frame: 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).

  3. Self-reported trouble with eating evaluated by a visual analog scale

    Time frame: 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).

  4. Comparison of the palate healing process evaluated through linear measurements (millimiter)

    Time frame: 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.

  5. Number of analgesic pills taken after surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 19, 2019
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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