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

NCT05171400 | Unknown

• 1 other identifier: UEPJMF11
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound Healing; Insulin; Palate; Wound

Keywords

Wound Healing; Drug Delivery System; Insulin; Fibroin

Outcome Measures

Primary Outcomes (1)

• Change in the Remaining wound healing (RWA)

  Photographs will be taken from palatal wound with brightness, distance, and angle standardized. A scale will be placed in the palate as a reference to measure the area. These photographs will be exported to an image software (Image J - NIH, Bethesda, USA), and the wound area will be measured in square millimeters (Dias et al., 2015).

  90 days.

Secondary Outcomes (10)

• Tissue Thickness (TT)

  90 days

• Epithelialization (E)

  90 days

• Early- wound healing index (EWHI)

  14 days

• Tissue Edema (TE)

  7 days

• Oral Health Impact Profile

  14 days

Study Arms (3)

Control Group (CG)

SHAM COMPARATOR

The palatal wound area will not receive any treatment

Procedure: Palatal Wound

Blank Film Group (BF)

EXPERIMENTAL

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

Procedure: Palatal Wound; Device: Palatal Wound treated with Silk Fibroin Film

Insulin-loaded film (IF)

EXPERIMENTAL

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

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

Interventions

Palatal Wound PROCEDURE

With the goal to harvest the free gingival graft (FGG), an 8mm diameter scalpel will be used to ensure standardized wounds. Thereafter, a 2-mm thick FGG will be removed. The wound area will receive 4.0 silk sutures.

Blank Film Group (BF); Control Group (CG); Insulin-loaded film (IF)

Palatal Wound treated with Silk Fibroin Film DEVICE

With the goal to harvest the free gingival graft (FGG), an 8mm diameter scalpel will be used to ensure standardized wounds. Thereafter, a 2-mm thick FGG will be removed. The wound area will receive a silk fibroin film and 4.0 silk sutures.

Blank Film Group (BF)

Palatal Wound treated with Insulin-loaded Silk Fibroin Film DEVICE

With the goal to harvest the free gingival graft (FGG), an 8mm diameter scalpel will be used to ensure standardized wounds. Thereafter, a 2-mm thick FGG will be removed. The wound area will receive a silk fibroin film loaded with insulin and 4.0 silk sutures.

Insulin-loaded film (IF)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

Mauro Pedrine Santamaria and Manuela Maria Viana Miguel

São José dos Campos, São Paulo, 12245000, Brazil

RECRUITING

Related Publications (5)

• Teuschl AH, Zipperle J, Huber-Gries C, Kaplan DL. Silk fibroin based carrier system for delivery of fibrinogen and thrombin as coagulant supplements. J Biomed Mater Res A. 2017 Mar;105(3):687-696. doi: 10.1002/jbm.a.35940. Epub 2016 Nov 7.

  PMID: 27756117 BACKGROUND

• Kamalathevan P, Ooi PS, Loo YL. Silk-Based Biomaterials in Cutaneous Wound Healing: A Systematic Review. Adv Skin Wound Care. 2018 Dec;31(12):565-573. doi: 10.1097/01.ASW.0000546233.35130.a9.

  PMID: 30475285 BACKGROUND

• Chen X, Liu Y, Zhang X. Topical insulin application improves healing by regulating the wound inflammatory response. Wound Repair Regen. 2012 May-Jun;20(3):425-34. doi: 10.1111/j.1524-475X.2012.00792.x.

  PMID: 22564234 BACKGROUND

• Dias SB, Fonseca MV, Dos Santos NC, Mathias IF, Martinho FC, Junior MS, Jardini MA, Santamaria MP. Effect of GaAIAs low-level laser therapy on the healing of human palate mucosa after connective tissue graft harvesting: randomized clinical trial. Lasers Med Sci. 2015 Aug;30(6):1695-702. doi: 10.1007/s10103-014-1685-2. Epub 2014 Nov 6.

  PMID: 25373688 BACKGROUND

• Santamaria MP, Mathias-Santamaria IF, Ferreira Bonafe AC, Gonzalez OA, Kirakodu S, Monteiro MF, Casarin RCV, Shaddox LM, Miguel MMV. Microbiome and Inflammatory Biomarkers Associated With Palatal Wound Healing. J Periodontal Res. 2025 Jul;60(7):664-675. doi: 10.1111/jre.13373. Epub 2025 Jan 13.

  PMID: 39801488 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Wounds and Injuries

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mauro P Santamaria, PhD

  Sao Paulo State University - Brazil

  STUDY DIRECTOR

• Manuela Maria V Miguel, MS

  Sao Paulo State University - Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauro P Santamaria, PhD

CONTACT

(12) 39479055; mauro.santamaria@unesp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a double-blind, parallel, superiority, randomized clinical trial with 3 months of follow-up.

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: December 28, 2021
• Study Start: July 2, 2021
• Primary Completion: August 2, 2022
• Study Completion: December 20, 2022
• Last Updated: December 28, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After the study completion.

Locations

BR (1)