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

NCT05171400 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-12-28

No results posted yet for this study

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

Interventions

PROCEDURE

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.

DEVICE

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.

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.

Sponsors & Collaborators

  • Universidade Estadual Paulista Júlio de Mesquita Filho

    lead OTHER

Principal Investigators

  • Mauro P Santamaria, PhD · Sao Paulo State University - Brazil

  • Manuela Maria V Miguel, MS · Sao Paulo State University - Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2022-08-02
Completion
2022-12-20

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05171400 on ClinicalTrials.gov