Diabetes MellitusNCT07500935
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
A study testing Free gingival graft in people with Diabetes Mellitus and Gingival Recession, Generalized, run by Mauro Santamaria at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate local and systemic factors involved in palatal mucosal healing after Free Gingival Graft harvest in diabetic patients and to compare them with those in non-diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Gingival Recession, Generalized, Gingival Recession, Localized
- What is being tested?
- Free gingival graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2026to Apr 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged ≥ 18 years;
- non-diabetic and diabetic patients (HbA1c>7% (American Diabetes Association 2025) managed with oral hypoglycemic agents or insulin;
- in the need of gingival recession treatment (RT1) in upper or lower arches with identifiable or restored cement-enamel junction (CEJ);
- periodontal stable (BoP ≤25%)(Lang et al. 2003);
- no morphological or pathological conditions in the palatal mucosa.
Who cannot join
- patients with cardiovascular, blood dyscrasias, and immunodeficiency that contraindicate surgical procedures;
- taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
- Pregnancy/lactation (assessed via self-report);
- current opportunistic oral lesions that mainly colonize the palate region;
- subjects that have taken antibiotics within the last 3 months or need for antibiotic prophylaxis;
- prisoners;
- signs or symptoms of active extra-oral head and neck infection (swelling) as determined by a dentist at the time of evaluation;
- subjects who cannot read or speak English or Spanish, and do not agree to having the assistance of an interpreter
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
College of Dentistry - University of Kentucky
Lexington, Kentucky, 40536
Mauro Pedrine Santamaria, DDS, Ms, PhD, 859 323 6297, maurosantamaria@uky.edu
Dawn Dawson, 859 323-5409, dawn.dawson@uky.edu
About this study
Official title: Oral Mucosa Wound Healing in Diabetic Patients. A Clinical Study on Open and Closed Wounds
The goal of this clinical trial is to evaluate local and systemic factors involved in palatal mucosal healing after Free Gingival Graft harvest in diabetic patients and to compare them with those in non-diabetic patients.
Diabetic and non-diabetic volunteers of both sexes aged ≥ 18 years with gingival recession may participate. The main questions it aims to answer are:
Read more
- If the palatal wound healing (area of the wound) and percentage of wound epithelialization are different in diabetics compared to non-diabetics.
- If different factors, such as the oral microbiome, inflammatory markers, and others, are associated with the clinical outcome.
Participants will be asked:
- Receive the procedure to treat their gingival recession defects
- To attend follow-up visits at 7, 14, 30, and 90 days after treatment.
- To provide different biological samples
- To answer different questionnaires.
- Being tested
- Free gingival graft
- Keywords
- gingival recession, diabetes, wound healing
- Medical subject headings
- Diabetes Mellitus, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival graftProcedure or surgery
Volunteers with gingival recession will be treated with coronally advanced flap and connective tissue graft (CTG). The CTG will be obtained by harvesting a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm from the palatal area between the distal of the canine and the mesial aspect of the first molar. The palatal wound will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes group | Experimental | Diabetic volunteers with gingival recession will be treated with coronally advanced flap and connective tissue graft (CTG). The CTG will be obtained by harvesting a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm from the palatal area between the distal of the canine and the mesial aspect of the first molar. The palatal wound will be evaluated. Receives: Procedure: Free gingival graft |
| Non-diabetes group | Active comparator | Non-diabetic volunteers with gingival recession will be treated with coronally advanced flap and connective tissue graft (CTG). The CTG will be obtained by harvesting a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm from the palatal area between the distal of the canine and the mesial aspect of the first molar. The palatal wound will be evaluated. Receives: Procedure: Free gingival graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remaining wound area (RWA)
The RWA will be measured in square millimeters using software (Image J- NIH, Bethesda, Maryland, USA) at baseline (trans-operative) and 1, 2, 4, and 12 weeks after the surgery
Measured: 3 months
Secondary outcomes (4)
Epithelialization - EPT
Standardized photographs will be taken after a disclosure solution (Disclosing Agent, Dentsply, Charlotte, NC, USA) application in the wound area at 1,2, 4, and 12 weeks postoperatively. The epithelialized area was calculated as the percentage of the original wound area using software (Image J- NIH, Bethesda, Maryland, USA) calibrated with a measuring scale in the palate.
Measured: 3 months
Insomnia Severity Index Survey
The insomnia survey scores range from 0 to 28 with a higher score indicating greater insomnia.
Measured: Baseline and up to 4 weeks
Tissue thickness - TT
An endodontic spreader with a stop rubber will be inserted at the center of the wound area until reaching the bone. The distance between the instrument tip and the rubber stopper will be measured with a digital caliper
Measured: 3 months
Inflammatory markers
The wound exudate may be collected 1 week after the procedure. Two paper strips (periopaper, Oraflow, Inc.) per wound will be individually placed and left in position for 40-60 s each. Before sampling, the wound will be gently rinsed and dried using water and an air spray. Relative isolation will then be performed immediately. If contamination with blood or saliva occurs, the paper strip will be discarded, and a new sample will be collected. In sequence, both paper strips will be placed into Eppendorf tubes and stored at -80º Celsius for further processing of inflammatory markers by Multiplex assay
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start9 Sep 2026
- Primary completionApr 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mauro Santamaria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mauro Santamaria, University of Kentucky
- Investigators
- Mauro Pedrine Santamaria, DDS, Ms, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500935
- Sponsor's protocol ID
- IRB-109004
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this study, including demographic variables, baseline characteristics, clinical measurements, outcome variables, and relevant covariates. may be made available upon a reasonable request.
Publications
Miguel MMV, Mathias-Santamaria IF, Rossato A, Ferraz LFF, Rangel TP, Casarin RCV, Tatakis DN, Santamaria MP. Enamel matrix derivative effects on palatal mucosa wound healing: Randomized clinical trial. J Periodontal Res. 2021 Dec;56(6):1213-1222. doi: 10.1111/jre.12934. Epub 2021 Sep 19.
PubMed 34541683Santamaria MP, Mathias-Santamaria IF, Ferreira Bonafe AC, Gonzalez OA, Kirakodu S, Monteiro MF, Casarin RCV, Shaddox LM, Miguel MMV. Microbiome and Inflammatory Biomarkers Associated With Palatal Wound Healing. J Periodontal Res. 2025 Jul;60(7):664-675. doi: 10.1111/jre.13373. Epub 2025 Jan 13.
PubMed 39801488