Comparing palatal wound healing in diabetic and non-diabetic patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the healing of open wounds in the palatal mucosa between diabetic and non-diabetic patients. It will evaluate clinical outcomes, patient-centered measures, inflammatory biomarkers, and the composition of the wound microbiome. A total of 50 patients will be divided into two groups: one consisting of diabetic patients and the other of normoglycemic patients, both undergoing surgery for mucogingival defect correction with free gingival grafts. The study will assess various parameters over a three-month period to understand the impact of diabetes on wound healing.

Why it matters

Who can join: the full rules

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).

Where it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.