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Recruiting NCT07386457

Taking Measurements of a Gum Graft Site as it Heals

— Observational Gingival Recession

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gingival graft surgery to treat gingival recession.
Who it may be relevant to
Registry conditions: Gingival Recession. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Dimensional Changes During Early Healing Following Subepithelial Connective Tissue Graft for Root Coverage

Overview

This is an observational study. The participants in this study will be patients at the Graduate Periodontics Clinic at The Ohio State University who are planning to get a gingival graft to treat their gum recession. Gingival grafts are a common way to treat this recession. The grafting surgery is not part of the study. The main purpose of this study is to better understand the normal healing of a gum graft. In order to do that, the investigators will take different kinds of measurements. 1. It is common for the tissue around the graft to have some swelling after the surgery. The investigators will measure the amount of swelling at different times as the graft heals. This will be done with a digital scanner which is passed over the area. 2. A device which measures blood flow will be used to see how new blood vessels are forming. This is also a device which is only passed over the area, so it is not invasive. 3. Saliva samples will be taken from around the teeth using sterile paper strips. This fluid will be analyzed for substances related to wound healing. 4. Participants will fill out questionnaires about their experience with the graft healing.

Interventions

  • Procedure Gingival graft surgery to treat gingival recession
    Subepithelial connective tissue grafting (SCTG) is a common procedure for the treatment of gingival recession and involves the autotransplantation of connective tissue from a donor site to the site of recession.

Primary outcome measures

  • Tissue Volume Change [Time frame: 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]
  • Correlation with Graft Exposure [Time frame: 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]
  • Inflammatory Cytokines [Time frame: 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]
  • Microvascular blood flow [Time frame: 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]
  • Post-operative Pain and Analgesic Use [Time frame: 2, 3, 7, 14 and 21 days after surgery]
Secondary outcome measures (1)
  • Thickness of the Gingival Flap and Graft [Time frame: Day of surgery]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • The Ohio State University Graduate Periodontics Clinic — Columbus

Identifiers

NCT: NCT07386457 · 2025H0007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗