What is this study trying to find out about wound healing in diabetic and non-diabetic patients?

This study aims to compare how wounds in the palate heal in people with and without diabetes. Researchers want to understand differences in clinical healing, patient comfort, immune responses, and the wound's bacterial makeup. The study is sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho and helps improve knowledge about oral tissue repair affected by diabetes.

Who may be eligible for this wound healing clinical trial?

Adults aged 18 to 80 years with good oral hygiene can participate. Both diabetic individuals with type 2 diabetes for over 5 years and non-diabetic individuals may join. People who are pregnant, breastfeeding, or smoke are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this wound healing clinical trial?

Study-related care, including the surgical procedure and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs outside the study procedures.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 80Years

All Genders

Healthy Volunteers

ID06540690

Study Comparing Healing of Palatal Wounds in Adults With and Without Diabetes Using Free Gingival Grafts

Led by Universidade Estadual Paulista Júlio de Mesquita Filho · Updated on 2024-08-06

Participants Needed

Research Sites

22 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the differences in healing of open wounds in the palatal mucosa between diabetic and non-diabetic patients. This controlled clinical trial aims to better understand how diabetes affects the repair of oral tissues by evaluating clinical signs, patient experiences, immune responses, and the composition of bacteria in the wound. The study enrolls adults with and without type 2 diabetes to compare these factors during healing. Participants will undergo surgery to repair gum tissue defects using a free gingival graft taken from the palate, creating a standardized wound. The study includes two groups one with diabetic patients and one with normoglycemic non-diabetic patients. Both groups will have similar surgical procedures and their healing will be analyzed over a 3-month period. Researchers will monitor wound closure, tissue thickness, epithelial growth, swelling, discomfort, and the wounds bacterial environment. During the study, participants will have multiple assessments including wound area measurements at various time points up to 90 days after surgery. Patient-reported outcomes like pain and quality of life will be tracked, along with biological samples such as saliva and tissue for immune and microbiome analysis. The study will use clinical exams, laboratory tests, and questionnaires to gather comprehensive data on healing and patient experience.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Patients aged 18 to 80 years
Systemically healthy patients with good oral hygiene (plaque and gingival index less than 25%)
No morphological or pathological conditions on the palatine donor area
Indication for tooth extraction and ridge preservation
Teeth involved and adjacent teeth have no periodontal attachment loss
Patients diagnosed with type 2 diabetes for more than 5 years using oral medication or insulin, with HbA1c between 6.1% and 8.5%
Non-diabetic patients with HbA1c below 6.1%
Patients who provide signed informed consent after explanation of risks and benefits

You will not qualify if you...

Patients with systemic conditions contraindicating surgery (e.g., cardiovascular problems, immunodeficiency)
Use of medications interfering with wound healing or contraindicating surgery
Current smokers
Pregnant or breastfeeding patients
Patients with prior periodontal surgery in the study area
Presence of opportunistic oral lesions, especially on the palate
Use of dental prosthesis covering the palate
Thin palatal mucosa (~2.0mm)

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo surgery to harvest a free gingival graft from the palate, creating a standardized wound, followed by suturing of the wound area.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Up to 3 months after surgery

Participants are monitored for wound healing and recovery through clinical evaluations and patient-centered assessments, including wound area, epithelialization, tissue thickness, edema, discomfort, and biomarker analyses.

Multiple visits at baseline, 3, 7, 14, 21, 30, and 90 days after surgery