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Completed NCT07554625

Volumetric Changes After Free Gingival Graft: Tuberosity vs Palatal Donor Site (VolFGG-TP)

Conditions: Gingival Recession, Periodontal Plastic Surgery

Sex: All
Ages: 20 Years – 40 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 40
Sponsor: Hooman Hashemzadeh

Location: Ondokuz Mayis University, Faculty of Dentistry, Department of Periodontology Samsun Samsun

Summary

This randomized controlled clinical trial evaluated volumetric changes at recipient and donor sites following free gingival graft (FGG) surgery, comparing two different palatal donor regions. Forty systemically healthy non-smoking adults aged 20-40 years with Miller Class I gingival recession defects at the mandibular anterior teeth (teeth 31, 32, 41, and 42) were randomly allocated using a sealed envelope method into two groups based on the donor site: (1) the anterior palatal region (from the distal of the canine to the first molar), and (2) the posterior palatal/tuberosity region (between the first molar and the tuberosity). All grafts were harvested targeting a standardized size of 8x10 mm (80 mm²). Digital intraoral scans (3Shape TRIOS 5) were obtained preoperatively and at 1, 3, and 6 months postoperatively. Volumetric changes at both recipient and donor sites were measured using STL-based superimposition in Exocad software. The aim was to compare time-dependent volumetric change patterns at both the recipient and donor sites between the two donor groups.

Eligibility Criteria

Inclusion Criteria: * Adults aged 20 to 40 years (both male and female) * Presence of Miller Class I gingival recession at mandibular anterior teeth (teeth 31, 32, 41, and 42) * Systemically healthy (no known systemic diseases) * Non-smokers * Adequate oral hygiene * Able and willing to provide written informed consent and attend follow-up visits Exclusion Criteria: * Pregnancy or lactation * Current or past smoking * Diagnosis of diabetes mellitus * Use of isotretinoin or similar systemic anti-acne medications * Inadequate oral hygiene * Current anticoagulant therapy * Systemic contraindications to periodontal surgery * History of previous periodontal surgery at the recipient site

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07554625). StuddyBuddy aggregates publicly available trial information.