Manufacturing, Characterization and Evaluation of the Effect of Silk Fibroin Membranes, Loaded or Not With Neurotensins on Open Wounds in the Palate

Universidade Estadual Paulista Júlio de Mesquita Filho

Status: Unknown

Conditions: Wound Healing; Palate; Wound

Treatments: Device: Palatal Wound treated with Silk Fibroin Film; Device: Palatal Wound treated with Neurotensin-loaded Silk Fibroin Film; Procedure: Palatal Wound

Study type: Interventional

Funder types: Other

Identifiers

NCT05191082

UEPJMF 12

Details and patient eligibility

About

The aim of the present study will be to manufacture and characterize silk fibroin membranes loaded or not with neurotensin and to evaluate clinical, patient-centered and immunological parameters the effect of using these membranes on open wounds on the human palate.

Full description

Surgical procedures for the reconstruction of gingival and peri-Implant tissues with the purpose of restoring function and aesthetics are commonly used in the dental practice. The use of free gingival graft (FGG), despite being considered the gold standard, causes great morbidity and postoperative pain. Thus, in order to reduce these complications, some biomaterials have been explored to accelerate healing and bring greater comfort to the patient. The present study aims to: 1. manufacture silk fibroin membranes (SF), loaded or not with neurotensin (NT); 2. evaluate, clinically and immunologically, the effect of the membranes on open wounds at palate sites. After the manufacture of the membranes they will be characterized by visual aspect, thickness, mechanical properties, surface texture, water vapor permeability, enzymatic degradation and swelling. Posteriorly, sixty six (n = 66) patients requiring exodontia and ridge preservation for future implant placement will be randomly assigned into three groups: Control - Free Gingival Graft (n = 22): extraction and Free Gingival Graft for sealing the alveolus entrance; Group SF - Fibroin membrane (n = 22): extraction and Free Gingival Graft for sealing the alveolus entrance and placement of the fibroin membrane at the palatal wound site; Group SF + NT - Free Gingival Graft + Neurotensin-loaded Fibroin Membrane (n = 22): extraction and Free Gingival Graft for sealing the alveolus entrance and placement of neurotensin-loaded fibroin membrane at the palatal wound site. The repair of the palatine donor area will be evaluated by clinical parameters such as remaining wound area, tissue thickness, re-epithelialization and early-wound healing index at baseline, 7, 14, 21, 30, 45, and 90 days after the procedure; and patient-centered outcomes by post-operative discomfort, tissue edema and number of analgesic pills used for 14 days after the procedure. In addition, inflammatory cytokines and growth factors will be assessed using the palatal wound inflammatory exudate 3 and 7 days after surgery. For the descriptive statistics, the mean ± standard deviation will be used; Normality: Shapiro-Wilk test; Clinical trials: ANOVA for intra and inter group calculations + Tukey test for multiple comparisons when the Shapiro-Wilk p value ≥ 0.05. If p Shapiro-Wilk <0.05, will be analyzed using the Friedman test (intragroup) and Mann-Whitney tests (intergroup); Parameters centered on patients: T test.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients at least 18 years old, healthy systemically, with good oral hygiene, assessed by means of a plaque index and gingival index less than 25% (O'Leary et al., 1972)
• Patients with no morphological or pathological changes in the donor palatal region;
• Patients who have an indication for extraction and with an indication to preserve the socket for future implant installation;
• The tooth included in the study, as well as the adjacent teeth, must not have loss of periodontal insertion.

Exclusion criteria

• Patients with systemic problems (cardiovascular changes, blood dyscrasias, immunodeficiency, diabetes, among others), who contraindicate the surgical procedure;
• Patients who use medications that interfere with wound healing;
• Pregnant or lactating patients;
• Patients who present opportunistic oral lesions, mainly colonizing the palate region;
• Smoking patients;
• Patients undergoing orthodontic treatment;
• Patients already submitted to periodontal surgery in the area of interest in the present study;
• Patients with a history of allergy to any type of material used in the present study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 3 patient groups

Control Group (CG)

Sham Comparator group

Description:

The palatal wound area will not receive any treatment

Treatment:

Procedure: Palatal Wound

Silk Fibroin Film - SF

Experimental group

Description:

The palatal wound area will receive silk fibroin film as a dressing

Treatment:

Device: Palatal Wound treated with Silk Fibroin Film

Procedure: Palatal Wound

Neurotensin-loaded Silk Fibroin Film - SF + NT

Experimental group

Description:

The palatal wound area will receive a neurotensin-loaded silk fibroin film as a drug delivery system

Treatment:

Procedure: Palatal Wound

Device: Palatal Wound treated with Neurotensin-loaded Silk Fibroin Film