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

NCT ID: NCT05171400

Last Updated: 2021-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-02

Study Completion Date

2022-12-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Wound Healing Insulin Palate; Wound

Keywords

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Wound Healing Drug Delivery System Insulin Fibroin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a double-blind, parallel, superiority, randomized clinical trial with 3 months of follow-up.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control Group (CG)

The palatal wound area will not receive any treatment

Group Type SHAM_COMPARATOR

Palatal Wound

Intervention Type 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)

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

Group Type EXPERIMENTAL

Palatal Wound

Intervention Type 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.

Palatal Wound treated with Silk Fibroin Film

Intervention Type 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.

Insulin-loaded film (IF)

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

Group Type EXPERIMENTAL

Palatal Wound

Intervention Type 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.

Palatal Wound treated with Insulin-loaded Silk Fibroin Film

Intervention Type 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.

Interventions

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Palatal Wound

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.

Intervention Type PROCEDURE

Palatal Wound treated with Silk Fibroin Film

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.

Intervention Type DEVICE

Palatal Wound treated with Insulin-loaded Silk Fibroin Film

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.

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role lead

Responsible Party

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Mauro Pedrine Santamaria

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mauro P Santamaria, PhD

Role: STUDY_DIRECTOR

Sao Paulo State University - Brazil

Manuela Maria V Miguel, MS

Role: PRINCIPAL_INVESTIGATOR

Sao Paulo State University - Brazil

Locations

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Mauro Pedrine Santamaria and Manuela Maria Viana Miguel

São José dos Campos, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Mauro P Santamaria, PhD

Role: CONTACT

Phone: (12) 39479055

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 27756117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30475285 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22564234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25373688 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39801488 (View on PubMed)

Other Identifiers

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UEPJMF11

Identifier Type: -

Identifier Source: org_study_id