NCT06540690 Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients
| NCT ID | NCT06540690 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidade Estadual Paulista Júlio de Mesquita Filho |
| Condition | Palate; Wound |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2026-08-01 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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: