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COMPLETED
NCT07554625
NA

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

Sponsor: Hooman Hashemzadeh

View on ClinicalTrials.gov

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.

Official title: Volumetric Analysis of Recipient and Donor Sites Following Free Gingival Graft Surgery Harvested From Different Palatal Donor Sites: A Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

20 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2023-12-01

Completion Date

2025-05-01

Last Updated

2026-04-28

Healthy Volunteers

Yes

Interventions

PROCEDURE

Free Gingival Graft Surgery

Free gingival graft (FGG) surgery was performed under local infiltration anesthesia (Ultracain DS, epinephrine 1:200,000) by a single experienced operator. At the recipient site, a split-thickness recipient bed was prepared at the buccal aspect of mandibular anterior teeth presenting Miller Class I gingival recession. The autogenous free gingival graft was harvested from the assigned palatal donor site (either anterior palatal or posterior palatal/tuberosity region, as per randomization) targeting dimensions of 8x10 mm. The graft was then secured at the recipient site using five 7-0 polypropylene monofilament sutures. No sutures were placed at the donor site; the wound was left to heal by secondary intention. Sutures at the recipient site were removed between postoperative days 10 and 14. All patients received standardized postoperative instructions and analgesic recommendations.

Locations (1)

Ondokuz Mayis University, Faculty of Dentistry, Department of Periodontology

Samsun, Samsun, Turkey (Türkiye)