Volumetric Analysis of Recipient and Donor Sites Following Free Gingival Graft Surgery Harvested From Different Palatal Donor Sites: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Volumetric change at the recipient site
Study Overview
Brief 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.
Detailed Description
BACKGROUND:
Free gingival graft (FGG) is a well-established procedure to augment keratinized tissue width and manage gingival recession defects. Despite widespread clinical use, comparative data on volumetric outcomes from different palatal donor sites remain limited, and most existing studies rely on one-dimensional clinical measurements rather than volumetric analysis. Emerging evidence suggests that donor tissue composition may differ between anterior palatal and posterior palatal/tuberosity regions, potentially influencing graft behavior at the recipient site.
STUDY DESIGN:
Single-center, parallel-group, randomized controlled clinical trial with 1:1 allocation via sealed envelope randomization.
INTERVENTION:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Anterior Palatal Donor Group
Free gingival graft was harvested from the anterior palatal region, defined as the area between the distal of the maxillary canine and the first molar. The graft was targeted to be 8x10 mm (approximately 80 mm²) in dimension. After harvesting, the graft was placed at the recipient site (Miller Class I gingival recession at mandibular anterior teeth 31, 32, 41, 42) and stabilized with five 7-0 polypropylene sutures. The donor site was left to heal by secondary intention without sutures.
Intervention: Free Gingival Graft from Anterior Palatal Donor Site (Procedure)
Posterior Palatal / Tuberosity Donor Group
Free gingival graft was harvested exclusively from the maxillary tuberosity region. The graft was targeted to be 8x10 mm (approximately 80 mm²) in dimension. After harvesting, the graft was placed at the recipient site (Miller Class I gingival recession at mandibular anterior teeth 31, 32, 41, 42) and stabilized with five 7-0 polypropylene sutures. The donor site was left to heal by secondary intention without sutures.
Intervention: Free Gingival Graft from Posterior Palatal / Tuberosity Donor Site (Procedure)
Outcomes
Primary Outcomes
Volumetric change at the recipient site
Time Frame: 1, 3, and 6 months postoperatively
Standardized volumetric change (mm³) at the recipient site compared with preoperative baseline (T0), measured via three-dimensional STL-based superimposition of intraoral scans (3Shape TRIOS 5) using Exocad software. Volumetric data were mathematically normalized to a theoretical standard graft surface area of 80 mm² (8x10 mm) to account for minor graft size variations. Negative values indicate volume loss; positive values indicate volume gain relative to baseline.
Secondary Outcomes
- Volumetric change at the donor site(1, 3, and 6 months postoperatively)
- Time × donor-site interaction effect on volumetric change at the recipient site(Across 1, 3, and 6 months postoperatively)
Investigators
Hooman Hashemzadeh
Sub-Investigator, Department of Periodontology
Ondokuz Mayıs University