Status:
RECRUITING
Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients
Lead Sponsor:
Universidade Estadual Paulista Júlio de Mesquita Filho
Conditions:
Palate; Wound
Wound Heal
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
Detailed Description
The use of autogenous grafts from the palate for the reconstruction of gingival tissues is considered the gold standard for various periodontal and peri-implant reconstructions. Given the current agin...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 6 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06540690
Start Date
August 1 2023
End Date
January 6 2027
Last Update
August 6 2024
Active Locations (2)
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1
College of Dentistry - São José dos Campos, Sao Paulo State University
São José dos Campos, São Paulo, Brazil, 12245-310
2
Mauro Pedrine Santamaria and Ana Carolina Ferreira Bonafe
São José dos Campos, São Paulo, Brazil, 12245000