Observational Study on Gum Graft Healing

This study is looking at how gum grafts heal after surgery for gingival recession (when your gums pull away from your teeth). You would be a patient at The Ohio State University's Graduate Periodontics Clinic already planning to have a subepithelial connective tissue graft (SCTG) procedure. Researchers will take measurements of your gum graft site as it heals to understand the normal healing process. They will use a digital scanner to measure swelling and look at other factors like how much of the graft is exposed and inflammatory cytokines (proteins involved in inflammation). This is an observational study, meaning the surgery itself is not part of the study, but researchers will collect information about your healing afterward. The study aims to enroll 15 participants between 18 and 50 years old.

Study design
This is an observational study involving about 15 participants. It is not a randomized or blinded study.
What's involved
You would have measurements taken immediately before and after surgery, then on days 2, 3, 7, 14, and 21 after surgery. These measurements include using a digital scanner.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for 21 days after your surgery to track healing.

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NCT07386457

Taking Measurements of a Gum Graft Site as it Heals

Recruiting
Not specifiedAges 18–50Observational
Ohio State University
~15 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:Gingival graft surgery to treat gingival recession

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tissue Volume Change
Measured over Immediately prior to surgery; immediately after surgery; Day 2 post-surgery; Day 3 post-surgery; Day 7 post-surgery; Day 14 post-surgery; Day 21 post-surgery
+4 more outcomes measured
Gingival Recession
1 sites across 1 states
Ohio1
  • Binnaz Leblebicioglu · PRINCIPAL_INVESTIGATOR · Ohio State University
Binnaz Leblebicioglu, DDS, MS, PhD
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Eligibility criteria

Inclusion

Clinical (oral) Ohio State University College of Dentistry patient, treatment planned for SCTG procedure
Miller Recession Class I, II, or III
Teeth; Maxillary or mandibular incisors, canines, pre-molars
Gingival Index ≤ 1
Plaque Index ≤ 1
Able and willing to provide informed consent
Able and willing to complete questionnaire

Exclusion

Carious lesions on the tooth selected for surgical root coverage
Taking any medications affecting the gingiva and/or oral mucosa: phenytoin, calcium channel blockers , cyclosporin A, immunostimulants/ immunomodulators
Quantitative and/or qualitative defects on host inflammatory cells
Organ transplant(s)
Type I or II diabetes
Currently pregnant or lactating
Usage of smokeless tobacco
Physical/mental handicap which can interfere with adequate oral hygiene performance
  • Tissue Volume ChangeImmediately prior to surgery; immediately after surgery; Day 2 post-surgery; Day 3 post-surgery; Day 7 post-surgery; Day 14 post-surgery; Day 21 post-surgery

    3-dimensional digital scans will be taken with an intraoral scanner. Once captured, pre- and post-treatment digital image files will be overlapped and analyzed for dimensional changes in the area of the graft. Using digital software, the investigators will calculate the percentage tissue volume change between each time point, using the post-operative scan as a reference.

  • Correlation with Graft ExposureImmediately prior to surgery; immediately after surgery; Day 2 post-surgery; Day 3 post-surgery; Day 7 post-surgery; Day 14 post-surgery; Day 21 post-surgery

    Surgical approaches for subepithelial connective tissue grafting can vary depending on site anatomical characteristics. The choice is often dictated by the anatomy of the site and the severity of the recession and sometimes by operator preference. For the purpose of this study, exposure of the graft will be analysed as an incidental occurrence as surgical needs dictate whether the graft will be exposed or not.

  • Inflammatory CytokinesImmediately prior to surgery; immediately after surgery; Day 2 post-surgery; Day 3 post-surgery; Day 7 post-surgery; Day 14 post-surgery; Day 21 post-surgery

    Saliva samples will be taken from around the teeth at the surgical site by using sterile paper strips. These will be used to study the release of inflammatory cytokines.

  • Microvascular blood flowImmediately prior to surgery; immediately after surgery; Day 2 post-surgery; Day 3 post-surgery; Day 7 post-surgery; Day 14 post-surgery; Day 21 post-surgery

    Laser Doppler Flowmetry (LDF) is a method of determining the real-time microvascular blood flow in soft tissue. LDF will allow the investigators to measure revascularization of the connective tissue graft and see if the degree of soft tissue dimensional change correlates with LDF measurements at certain time points.

  • Post-operative Pain and Analgesic Use2, 3, 7, 14 and 21 days after surgery

    A post-operative questionnaire will assess the subjects' post-operative pain using visual analog scales, including the location of the pain. The questionnaires will also assess the frequency and effectiveness of the analgesic prescribed.