Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT07386457

Conditions

Gingival Recession

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Gingival graft surgery to treat gingival recession

Study Details

Brief summary:

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.

Conditions

Gingival Recession

Study ID

NCT07386457

Start date

Apr 1, 2026

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

Grafting Surgery Recipients

Patients at the Graduate Periodontics Clinic at The Ohio State University who are having a gingival graft done to treat gingival recesssion.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Locations

The Ohio State University Graduate Periodontics Clinic

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Binnaz Leblebicioglu, DDS, MS, PhD

614-292-0371leblebicioglu.1@osu.edu

More Information

Sponsor

Ohio State University

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-04-20.