Comparing palatal wound healing in diabetic and non-diabetic patients
Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients: Controlled Clinical Trial and in Vitro Study
This study is testing how well wounds in the mouth heal in people with diabetes compared to those without diabetes after surgery to fix gum issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Universidade Estadual Paulista Júlio de Mesquita Filho Academic / other |
| Locations | 2 sites (São José dos Campos, São Paulo and 1 other locations) |
| Trial ID | NCT06540690 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the healing of open wounds in the palatal mucosa between diabetic and non-diabetic patients. It will evaluate clinical outcomes, patient-centered measures, inflammatory biomarkers, and the composition of the wound microbiome. A total of 50 patients will be divided into two groups: one consisting of diabetic patients and the other of normoglycemic patients, both undergoing surgery for mucogingival defect correction with free gingival grafts. The study will assess various parameters over a three-month period to understand the impact of diabetes on wound healing.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older, both diabetic patients with controlled type 2 diabetes and non-diabetic patients with good oral hygiene.
Not a fit: Patients with uncontrolled diabetes, significant periodontal disease, or other systemic health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into improved wound healing strategies for diabetic patients.
How similar studies have performed: Other studies have shown varying results in wound healing among diabetic and non-diabetic patients, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
São José dos Campos, São Paulo and 1 other locations
- College of Dentistry - São José dos Campos, Sao Paulo State University — São José dos Campos, São Paulo, Brazil (Recruiting)
- Mauro Pedrine Santamaria and Ana Carolina Ferreira Bonafe — São José dos Campos, São Paulo, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.