Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06540690

Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients: Controlled Clinical Trial and in Vitro Study

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

50

Participants Needed

2

Research Sites

22 weeks

Total Duration

On this page

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 wound's 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

Eligible

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
Not Eligible

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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Trial Site Locations

Total: 2 locations

1

College of Dentistry - São José dos Campos, Sao Paulo State University

São José dos Campos, São Paulo, Brazil, 12245-310

Actively Recruiting

2

Mauro Pedrine Santamaria and Ana Carolina Ferreira Bonafe

São José dos Campos, São Paulo, Brazil, 12245000

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

Similar Trials

A Cardiometabolic Health Program Linked With Clinical-Commun...

Hypertension

Actively Recruiting

3 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Effect of GaAIAs low-level laser therapy on the healing of human palate mucosa after connective tissue graft harvesting: randomized clinical trial.

Stephanie Botti Fernanandes Dias, Marcus Vinícius Alves Fonseca, Nídia Cristina Castro Dos Santos...

https://pubmed.ncbi.nlm.nih.gov/25373688

Early wound healing and patient morbidity after single-incision vs. trap-door graft harvesting from the palate--a clinical study.

Stefan Fickl, Kai R Fischer, Yvonne Jockel-Schneider...

https://pubmed.ncbi.nlm.nih.gov/24562700