Cicatrization, Pain, Postoperative, Palate; Wound
Conditions
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.
Interventions
DEVICETilapia skin
Application tilapia skin as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.
DEVICESurgical Wound Dressing
Application surgical wound dressing as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported pain perception evaluated by a visual analog scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Self-reported discomfort evaluated by a visual analog scale | 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). |
| Self-reported trouble with speech evaluated by a visual analog scale | 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). |
| Self-reported trouble with eating evaluated by a visual analog scale | 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). |
| Comparison of the palate healing process evaluated through linear measurements (millimiter) | 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. |
| Number of analgesic pills taken after surgery | 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. |
Countries
Brazil
Outcome results
None listed