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Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients
RECRUITINGN/ASponsored by Universidade Estadual Paulista Júlio de Mesquita Filho
Actively Recruiting
PhaseN/A
SponsorUniversidade Estadual Paulista Júlio de Mesquita Filho
Started2023-08-01
Est. completion2026-08-01
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06540690
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
Age: 18 Years – 80 YearsHealthy 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).
Conditions3
DiabetesPalate; WoundWound Heal
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Actively Recruiting
PhaseN/A
SponsorUniversidade Estadual Paulista Júlio de Mesquita Filho
Started2023-08-01
Est. completion2026-08-01
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06540690