3D comparison of soft tissue changes after modified versus conventional free gingival grafts
Official title: Three-Dimensional Direct Digital Evaluation of Soft Tissue Volumetric Changes After Modified Free Gingival Graft Surgery: A Randomized Controlled Clinical Trial
Run by Kahramanmaras Sutcu Imam University · NCT07409558 · Data updated 2026-11-12
This trial will try a modified free gingival graft against a conventional free gingival graft in adults with localized lower-front gum recession to see which better preserves soft tissue thickness and volume.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | Kahramanmaras Sutcu Imam University Academic / other |
| Locations | 1 site (Kahramanmaraş, Kahramanmaraş) |
| Status | Recruiting |
| Started | January 4, 2025 |
| Main results expected | July 1, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT07409558 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are systemically healthy non-smokers with localized Cairo Class II gingival recession ≥3 mm on mandibular incisors, probing depths ≤3 mm, shallow vestibule, minimal tooth mobility, and no cervical restorations may be eligible.
✕Probably not a fit
People who are pregnant or lactating, smokers, have untreated periodontal disease, poor oral hygiene, malpositioned/crowded teeth, systemic conditions or medications affecting healing, or ASA class III+ are unlikely to benefit or be eligible for this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized controlled trial enrolling 34 systemically healthy, non-smoking adults with localized Cairo Class II gingival recession on mandibular incisors. Participants are randomly assigned to receive either a conventional free gingival graft (FGG) or a modified free gingival graft (ModFGG) that uses a connective tissue pedicle to potentially improve vascularization. Clinical measurements and intraoral digital scans are taken at baseline and at 1, 3, and 6 months to allow three-dimensional overlay analysis of soft tissue thickness and volumetric changes, alongside linear measures such as recession depth, keratinized tissue height, and creeping attachment. The design aims to provide quantitative 3D data comparing tissue outcomes between the two grafting techniques.
Why it matters
Potential benefit: If successful, the modified technique could improve graft vascularization and lead to thicker, more stable soft tissue with less postoperative volume loss.
How similar studies have gone: Previous two-dimensional clinical reports have shown favorable root coverage and keratinized tissue gain with the modified technique, but volumetric 3D evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Systemically healthy individuals * Non-smokers * Presence of localized Cairo Class II gingival recession with a vertical recession depth of ≥3 mm on the buccal surfaces of mandibular incisors * Probing pocket depth of ≤3 mm at the tooth/teeth to be treated * No tooth mobility (mobility grade ≤1) * Absence of cervical composite restorations or non-carious cervical lesions * Presence of a shallow vestibule (\<5 mm) Exclusion Criteria: * Pregnancy or lactation * Untreated periodontal disease * Presence of parafunctional habits * Poor oral hygiene, defined as a full-mouth plaque score \>20% * Malpositioned, rotated, or crowded teeth in the buccal position * Known systemic diseases (e.g., acquired immunodeficiency syndrome, diabetes mellitus) * Any condition or medication that may affect gingival wound healing * ASA physical status classification III or higher
Where it's running
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Kahramanmaraş Sütçü İmam University
Kahramanmaraş, Kahramanmaraş, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: esra bozkurt
- Email: dtesrabozkurt@gmail.com
- Phone: +905533618725
Similar studies
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We will test if applying Theravex Tissue Care Plus during a modified free gingival graft and rinsing with Theravex Oral afterward helps adults with lower-front gum recession heal faster and get better root coverage than a saline placebo.
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This trial will test whether applying topical triamcinolone acetonide to the palatal donor site helps adults having free gingival graft surgery heal faster and with less pain than a standard collagen sponge.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.