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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07554625 on ClinicalTrials.gov