Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients
Recruiting now · Not applicable
Conditions studied: Palate; Wound, Wound Heal, Diabetes
In brief
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.
Key facts
- Study ID
- NCT06540690
- Run by
- Universidade Estadual Paulista Júlio de Mesquita Filho
- People needed
- 50
- Starts
- 2023-08-01
- Expected to finish
- 2027-01-06
- Last updated by the study team
- 2024-08-06
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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%.
You may not qualify if…
- 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 is running
- College of Dentistry - São José dos Campos, Sao Paulo State University — São José dos Campos, São Paulo, Brazil (enrolling)
- Mauro Pedrine Santamaria and Ana Carolina Ferreira Bonafe — São José dos Campos, São Paulo, Brazil (enrolling)
Full record on ClinicalTrials.gov
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