Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients
Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients: Controlled Clinical Trial and in Vitro Study
Universidade Estadual Paulista Júlio de Mesquita Filho
50 participants
Aug 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria8
- 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).
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Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06540690