Gingival RecessionNCT07386457
Taking Measurements of a Gum Graft Site as it Heals
An observational study of Gingival Recession, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Gingival graft surgery to treat gingival recession
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Graduate Periodontics Clinic
Columbus, Ohio, 43210
Binnaz Leblebicioglu, DDS, MS, PhD, 614-292-0371, leblebicioglu.1@osu.edu
About this study
Official title: 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.
- 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.
- 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.
- Saliva samples will be taken from around the teeth using sterile paper strips. This fluid will be analyzed for substances related to wound healing.
- Participants will fill out questionnaires about their experience with the graft healing.
- Conditions
- Gingival Recession
- Being tested
- Gingival graft surgery to treat gingival recession
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival graft surgery to treat gingival recessionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Gingival graft surgery to treat gingival recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2, 3, 7, 14 and 21 days after surgery
Secondary outcomes (1)
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.
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Apr 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binnaz Leblebicioglu, Ohio State University
- Investigators
- Binnaz Leblebicioglu, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386457
- Sponsor's protocol ID
- 2025H0007
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dimensional Changes During Early Healing Following Subepithelial Connective Tissue Graft for Root Coverage
- ClinicalTrials.gov ID
- NCT07386457
- Acronym / sponsor ID
- 2025H0007
- Conditions
- Gingival Recession
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- Saliva samples will be taken from around the teeth using sterile paper strips. This fluid will be analyzed for substances related to wound healing.
- Participants will fill out questionnaires about their experience with the graft healing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Grafting Surgery Recipients | – | Procedure: Gingival graft surgery to treat gingival recessionPatients at the Graduate Periodontics Clinic at The Ohio State University who are having a gingival graft done to treat gingival recesssion. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gingival graft surgery to treat gingival recessionSubepithelial 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. | Procedure or surgery | Grafting Surgery Recipients |
Primary outcome
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
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 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
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 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
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 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
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 Use
Time frame: 2, 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.
1 secondary outcome
Thickness of the Gingival Flap and Graft
Time frame: Day of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Gingival Recession
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Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
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i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Graduate Periodontics Clinic
Columbus, United States
Binnaz Leblebicioglu principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Recession, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.