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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04168125
• Other study ID #: Ceap
• Status: Recruiting
• Phase: Phase 1
• Start date: September 26, 2019
• Est. completion date: March 24, 2021

Study information

• Verified date: August 2020
• Source: University of Sao Paulo
• Contact: Gustavo GP Manfredi, MSc
• Phone: +5518981711825
• Email: gustavo.manfredi[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 24, 2021
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• Cicatrization
• Pain, Postoperative
• Palate; Wound

Intervention

Device:
• Tilapia skin
Application tilapia skin as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.
• Surgical Wound Dressing
Application surgical wound dressing as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.

Locations

Country	Name	City	State
Brazil	Bauru School of Dentistry	Bauru

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported pain perception evaluated by a visual analog scale	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).	14 days after the surgery
Secondary	Self-reported discomfort evaluated by a visual analog scale	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).	14 days after the surgery
Secondary	Self-reported trouble with speech evaluated by a visual analog scale	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).	14 days after the surgery
Secondary	Self-reported trouble with eating evaluated by a visual analog scale	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).	14 days after the surgery
Secondary	Comparison of the palate healing process evaluated through linear measurements (millimiter)	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.	30 days after the surgery
Secondary	Number of analgesic pills taken after surgery	Evaluate the patient's perception of postoperative pain and discomfort by counting the number of analgesic pills taken after the surgery.	14 days after the surgery