Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial

April 29, 2026 updated by: Mauro Santamaria

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:

  1. If the palatal wound healing (area of the wound) and percentage of wound epithelialization are different in diabetics compared to non-diabetics.
  2. 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • College of Dentistry - University of Kentucky
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Diabetes group
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.
Procedure: Free gingival graft
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.
Active Comparator: Non-diabetes group
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.
Procedure: Free gingival graft
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Remaining wound area (RWA)
Time Frame: 3 months
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
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index Survey
Time Frame: Baseline and up to 4 weeks
The insomnia survey scores range from 0 to 28 with a higher score indicating greater insomnia.
Baseline and up to 4 weeks
Epithelialization - EPT
Time Frame: 3 months
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.
3 months
Tissue thickness - TT
Time Frame: 3 months
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
3 months
Inflammatory markers
Time Frame: 2 weeks
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
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mauro Santamaria

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mauro Pedrine Santamaria, DDS, Ms, PhD, University Of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-109004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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