Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients

Launched by UNIVERSIDADE ESTADUAL PAULISTA JÚLIO DE MESQUITA FILHO · Aug 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well wounds in the roof of the mouth (the palate) heal in people with diabetes compared to those without diabetes. The researchers want to understand not just how the wounds close, but also how factors like the patient’s overall health, the germs on the wound, and other personal experiences affect healing. They are looking for participants who are 18 years or older and have good oral hygiene. This includes people with type 2 diabetes who have been diagnosed for at least five years and are managing their condition with medication, as well as non-diabetic individuals.

If you join this study, you'll undergo a procedure related to a tooth extraction, and the team will monitor your healing process closely. They will check things like the way your body responds to the healing, and they may ask about your experiences during recovery. Some people won’t be able to participate, such as those who smoke, are pregnant, or have certain health issues. If you think you might be eligible and are interested, you would need to sign a consent form after learning about the potential risks and benefits. This trial is currently looking for volunteers to help improve our understanding of wound healing in different patient groups.

Gender

ALL

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).