Taking Measurements of a Gum Graft Site as it Heals

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Gingival graft surgery to treat gingival recession

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Graduate Periodontics Clinic
      • Contact: Binnaz Leblebicioglu, DDS, MS, PhD; Phone Number: 614-292-0371; Email: leblebicioglu.1@osu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thickness of the Gingival Flap and Graft	Gingival biotype refers to biological groupings of gingival phenotypes. Biotype has repeatedly been shown to influence clinical outcomes and tissue responses. In this study, the investigators will take biotype into account by measuring the thickness of the flap after it has been raised using tissue callipers. Additionally, the investigators will measure the thickness of the graft using the same method. These measurements will allow the investigators to determine if the biotype of the patient relates to the amount of edema post-surgery, and if that edema is primarily occurring in the flap or the graft itself.	Day of surgery

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Binnaz Leblebicioglu, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession
• Other Study ID Numbers: 2025H0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO