A New Drug Delivery System - Silk Fibroin Film Loaded or Not With Insulin on Palatal Mucosa Wound Healing

Universidade Estadual Paulista Júlio de Mesquita Filho

Status: Unknown

Conditions: Insulin; Wound Healing; Palate; Wound

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05171400

UEPJMF11

Details and patient eligibility

About

The aim of the present study is to evaluate using clinical, patient-centered, immunological, microbiological, and histological parameters, the effect of silk fibroin films loaded or not with insulin in the repair of palatal mucosa open wounds.

Full description

There are several types of periodontal and peri-implant soft tissue defects that require surgical treatment to reestablishment function and aesthetics. Therefore, surgical procedures for the reconstruction of the gingival and peri-implant tissues are routinely performed. However, these procedures do not always have predictable outcomes, and problems with the wound healing process can occur, which can impair the outcomes. To overcome this problem, new materials, drugs, and devices have been used to improve the results of surgical procedures. The present study is a controlled clinical trial that will include seventy-five patients with an indication of anterior maxillary tooth extraction for ridge preservation. The ridge preservation will be performed and a free gingival graft harvest from the palatal mucosa will be used to seal the socket entrance. Thereafter, the palatal wound will be randomly assigned into 3 groups: Control Group (C; n=25): open wound on palatal mucosa that will receive no treatment. Blank Film Group (BF; n=25): open wound on palatal mucosa that will receive silk fibroin film as dressing. Insulin-loaded film (IF; n=25): open wound on palatal mucosa that will receive an insulin-loaded silk fibroin film as a delivery system. Clinical, immunological, histological, and microbiome parameters will be analyzed.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with at least 18 years, systemically healthy, with good oral hygiene, assessed by plaque index and gingival index less than 25% (Ainamo, Bay, 1975);
• Patients with no morphological or pathological conditions on the palatine donor area;
• Patients who present indication for extraction and ridge preservation;
• The tooth included in the study, as well as, the adjacent teeth do not present loss of periodontal insertion;
• Patients who agreed to and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the present study (Resolution no. 118 - May, 2012, and Ethics and Code of Professional Conduct in Dentistry - 118/12).

Exclusion criteria

• Patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure;
• Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
• Smokers patients;
• Pregnant or lactating patients;
• Patients who had had periodontal surgery on the study area;
• Patients who presents opportunistic oral lesions, mainly colonized the palate region;
• Use of dental prosthesis with palatal cover;
• Thin palatal mucosa (~2.0mm).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 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

Blank Film Group (BF)

Experimental group

Description:

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

Treatment:

Procedure: Palatal Wound

Device: Palatal Wound treated with Silk Fibroin Film

Insulin-loaded film (IF)

Experimental group

Description:

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

Treatment:

Procedure: Palatal Wound

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