Clinical Trials in Brazil / NCT06540690
Recruiting Not applicable

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

NCT06540690 · tracked via the Priya Life Science Brazil tracker
Phase
Not applicable
Started
2023-08-01
Last updated
2024-08-06

Condition(s) studied

Palate; WoundWound HealDiabetes

Investigational drug(s) / intervention(s)

Palatal Wound

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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). * Patients diagnosed with type 2 diabetes for more than 5 years who are using oral hypoglycemic agents or insulin supplementation, with HbA1c levels ranging from ≥ 6.1% to 8.5%. * Non-diabetic patients with HbA1c levels below 6.1%. 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).

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
College of Dentistry - São José dos Campos, Sao Paulo State University São José dos Campos São Paulo Recruiting
Mauro Pedrine Santamaria and Ana Carolina Ferreira Bonafe São José dos Campos São Paulo Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06540690 on ClinicalTrials.gov ↗ ← All trials in Brazil