3D comparison of soft tissue changes after modified versus conventional free gingival grafts
Three-Dimensional Direct Digital Evaluation of Soft Tissue Volumetric Changes After Modified Free Gingival Graft Surgery: A Randomized Controlled Clinical Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kahramanmaras Sutcu Imam University Academic / other |
| Locations | 1 site (Kahramanmaraş, Kahramanmaraş) |
| Trial ID | NCT07409558 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous two-dimensional clinical reports have shown favorable root coverage and keratinized tissue gain with the modified technique, but volumetric 3D evidence is limited.
Eligibility criteria
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 this trial is running
Kahramanmaraş, Kahramanmaraş
- Kahramanmaraş Sütçü İmam University — Kahramanmaraş, Kahramanmaraş, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: esra bozkurt
- Email: dtesrabozkurt@gmail.com
- Phone: +905533618725
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.