Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT06540690

Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients

Led by Universidade Estadual Paulista Júlio de Mesquita Filho · Updated on 2024-08-06

50

Participants Needed

2

Research Sites

179 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to characterize and compare the closure of open wounds in the palatal mucosa of diabetic and non-diabetic patients, evaluate clinical, patient-centered and immunological parameters as well as wound microbiome composition.

CONDITIONS

Official Title

Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older with good oral hygiene, shown by plaque and gingival indices below 25%
  • No morphological or pathological conditions on the palatal donor area
  • Patients requiring tooth extraction and ridge preservation
  • Teeth included in the study and adjacent teeth must not have periodontal insertion loss
  • Patients who provide informed consent after being fully informed about the study
  • Diabetic patients with type 2 diabetes for over 5 years using oral hypoglycemic agents or insulin and HbA1c between 61 6.1% and 8.5%
  • Non-diabetic patients with HbA1c below 6.1%
Not Eligible

You will not qualify if you...

  • Patients with systemic illnesses contraindicating surgery such as cardiovascular disease, blood disorders, immunodeficiency, or diabetes other than type 2
  • Patients taking medications that affect wound healing or contraindicate surgery
  • Current smokers
  • Pregnant or breastfeeding patients
  • Patients who have had periodontal surgery in the study area
  • Patients with opportunistic oral lesions, especially on the palate
  • Use of dental prosthesis covering the palate
  • Thin palatal mucosa approximately 2.0 mm thick

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

College of Dentistry - São José dos Campos, Sao Paulo State University

São José dos Campos, São Paulo, Brazil, 12245-310

Actively Recruiting

2

Mauro Pedrine Santamaria and Ana Carolina Ferreira Bonafe

São José dos Campos, São Paulo, Brazil, 12245000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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