Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.

May 5, 2026 updated by: Mauro Santamaria

Oral Mucosa Wound Healing in Diabetic Patients. A Clinical Study on Closed Wounds

The goal of this clinical trial is to evaluate local and systemic factors involved in oral mucosal healing after gingival recession treatment 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 gingival recession reduction and percentage of root coverage 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, 90, and 180 days after treatment.
  • To provide different biological samples
  • To answer different questionnaires.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • 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 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

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetes group
Procedure: Coronally Advance Flap associated with connective tissue graft (CAF+CTG)
A CAF will be performed following the gingival recession (GR) defect features extending beyond the mucogingival junction (MGJ) in a split-full-split thickness design. In sequence, a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm, will be harvested from the palatal area between the distal of the canine and the mesial aspect of the first molar. The FGG will be trimmed based on the GR defect features and de-epithelialized to achieve a final thickness of 1 mm. The de-epithelialized graft (CTG) will be sutured in position, at the level of the cement-enamel junction (CEJ), using interrupted absorbable sutures. Finally, the flap margin will be repositioned 2 mm coronal to CEJ
Active Comparator: Non-diabetes group
Procedure: Coronally Advance Flap associated with connective tissue graft (CAF+CTG)
A CAF will be performed following the gingival recession (GR) defect features extending beyond the mucogingival junction (MGJ) in a split-full-split thickness design. In sequence, a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm, will be harvested from the palatal area between the distal of the canine and the mesial aspect of the first molar. The FGG will be trimmed based on the GR defect features and de-epithelialized to achieve a final thickness of 1 mm. The de-epithelialized graft (CTG) will be sutured in position, at the level of the cement-enamel junction (CEJ), using interrupted absorbable sutures. Finally, the flap margin will be repositioned 2 mm coronal to CEJ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gingival recession reduction
Time Frame: 6 months
The amount of reduction in the gingival recession defect. It is calculated by subtracting the final gingival recession values from the initial values
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth
Time Frame: 6 month
measured in millimeters using a periodontal probe at the mid-buccal aspect
6 month
Clinical attachment level
Time Frame: 6 months
measured as probing depth + gingival recession
6 months
PROMIS Adult Sleep Disturbance Survey
Time Frame: Baseline and up to 4 weeks
The Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance survey has each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Baseline and up to 4 weeks
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
Change in Dentin hypersensitivity
Time Frame: Baseline and up to 6 months
The participants may be asked about the dentin hypersensitivity in the gingival recession site after a 3-second air blast and self-report esthetic perceptions before the surgery and 3 and 6 months after the surgical protocol.
Baseline and up to 6 months
Number of analgesics
Time Frame: 7 days
Number of analgesics taken on the current day for 7 days.
7 days
Discomfort
Time Frame: 7 days
Participants will be asked to report the discomfort level using a visual analog scale for 7 days after the surgery. Scale ranges from 0 to 10 with a higher score equating to increased discomfort.
7 days
Root Coverage Esthetic Score
Time Frame: 6 months
The aesthetics of the site will be assessed using the Root Coverage Esthetic - RES Score visually with score (0 "minimum" - 10 "maximum"). A higher score equates to a better esthetic outcome.
6 months
gingival crevicular fluid (GCF) inflammatory markers
Time Frame: 6 months
The gingival crevicular fluid (GCF) may be collected from the Gingival Recession defect sites before the surgery (visit 1), and 1-,2-, 4-, 12-, 24-weeks after the procedure. Two paper strips (periopaper, Oraflow, Inc.) will be inserted gently into the sulcus for 30 seconds. Before sampling, the area will be gently rinsed and dried using water and an air spray.
6 months

Collaborators and Investigators

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

Sponsor

Mauro Santamaria

Investigators

  • Principal Investigator: Mauro 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)

July 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 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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