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NCT Number: NCT07470281

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Gingival Diseases Gingival Recession Gingival Recession, Generalized Gingival Recession, Localized Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Probing depth

    Time frame: 6 month

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

  2. Clinical attachment level

    Time frame: 6 months

    measured as probing depth + gingival recession

  3. 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.

  4. 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.

  5. 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.

  6. Number of analgesics

    Time frame: 7 days

    Number of analgesics taken on the current day for 7 days.

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dawn G Dawson

CONTACT

[email protected]

8593235409

Sponsors and collaborators

Lead sponsor

Mauro Santamaria

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Mar 13, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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