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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-08-01 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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: * 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).
Frequently Asked Questions
Who can join the NCT06540690 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Palate; Wound. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06540690 currently recruiting?
Yes, NCT06540690 is actively recruiting participants. Visit ClinicalTrials.gov or contact Universidade Estadual Paulista Júlio de Mesquita Filho to inquire about joining.
Where is the NCT06540690 trial being conducted?
This trial is being conducted at São José dos Campos, Brazil, São José dos Campos, Brazil.
Who is sponsoring the NCT06540690 clinical trial?
NCT06540690 is sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho. The trial plans to enroll 50 participants.