Taking Measurements of a Gum Graft Site as it Heals

NCT07386457 | Recruiting

• 1 other identifier: 2025H0007
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 4.Participants will fill out questionnaires about their experience with the graft healing.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (5)

• Tissue Volume Change

  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.

  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

  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.

  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

  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.

  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

  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.

  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

  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.

  2, 3, 7, 14 and 21 days after surgery

Secondary Outcomes (1)

• Thickness of the Gingival Flap and Graft

  Day of surgery

Study Arms (1)

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.

Procedure: Gingival graft surgery to treat gingival recession

Interventions

Gingival graft surgery to treat gingival recession PROCEDURE

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.

Grafting Surgery Recipients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The patients will be recruited from the patient pool of the Ohio State graduate periodontics clinic. These patients are referred to the Ohio State clinics to treat gum recession. Potential participants will be recruited after they have been treatment planned for subepithelial connective tissue grafting in the periodontics clinic. At the time of treatment planning, the investigators will present the option to participate in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Graduate Periodontics Clinic

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Binnaz Leblebicioglu

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)