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

ConditionsDiabetes MellitusGingival Recession, GeneralizedGingival Recession, Localized
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMauro Santamaria

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Coronally Advance Flap associated with connective tissue graft (CAF+CTG)

    Procedure/Surgery

    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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Diabetes groupExperimental treatment 1 intervention
Group B: Non-diabetes groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

gingival recession reduction

The amount of reduction in the gingival recession defect. It is calculated by subtracting the final gingival recession values from the initial values

Time frame
6 months

Secondary outcomes

1

Probing depth

measured in millimeters using a periodontal probe at the mid-buccal aspect

Time frame
6 month
2

Clinical attachment level

measured as probing depth + gingival recession

Time frame
6 months
3

PROMIS Adult Sleep Disturbance Survey

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.

Time frame
Baseline and up to 4 weeks
4

Insomnia Severity Index Survey

The insomnia survey scores range from 0 to 28 with a higher score indicating greater insomnia.

Time frame
Baseline and up to 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mauro Santamaria

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: