Clinical trial NCT04168125: Use of Tilapia Skin for Palate Repair and Protection After Graft Removal
Official title: Use of Tilapia Skin for Palate Repair and Protection After Graft Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain, Postoperative
Palate; Wound
Cicatrization
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Self-reported pain perception evaluated by a visual analog scale
timeFrame: 14 days after the surgery
Secondary outcomes:
measure: Self-reported discomfort evaluated by a visual analog scale
timeFrame: 14 days after the surgery
measure: Self-reported trouble with speech evaluated by a visual analog scale
timeFrame: 14 days after the surgery
measure: Self-reported trouble with eating evaluated by a visual analog scale
timeFrame: 14 days after the surgery
measure: Comparison of the palate healing process evaluated through linear measurements (millimiter)
timeFrame: 30 days after the surgery
measure: Number of analgesic pills taken after surgery
timeFrame: 14 days after the surgery
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru School of Dentistry
Study officials:
affiliation: Bauru School of Dentistry - University of Sao Paulo
name: Adriana CP Sant'Ana, PhD
role: STUDY_DIRECTOR
References: