Volumetric Changes After Free Gingival Graft: Tuberosity vs Palatal Donor Site (VolFGG-TP)
NCT07554625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-08-13
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.
Conditions
- Gingival Recession
- Periodontal Plastic Surgery
Interventions
- PROCEDURE
-
Free Gingival Graft from Anterior Palatal Donor Site
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 anterior palatal region, defined as the area between the distal aspect of the maxillary canine and the first molar, targeting dimensions of 8 × 10 mm. The graft was 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.
- PROCEDURE
-
Free Gingival Graft from Posterior Palatal / Tuberosity Donor Site
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 maxillary tuberosity / posterior palatal region, targeting dimensions of 8 × 10 mm. The graft was 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.
Sponsors & Collaborators
-
Hooman Hashemzadeh
lead OTHER
Principal Investigators
-
Tugrul Kirtiloglu, PHD · Ondokuz Mayıs University
-
Emir Akan · Ondokuz Mayıs University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-12-01
- Primary Completion
- 2025-05-01
- Completion
- 2025-05-01
Countries
- Turkey (Türkiye)
Study Locations
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