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

NCT07554625 | Completed

• 1 other identifier: B.30.2.ODM.0.20.08/569
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession; Periodontal Plastic Surgery

Keywords

free gingival graft; palatal donor site; volumetric analysis; digital dentistry; intraoral scanner

Outcome Measures

Primary Outcomes (1)

• Volumetric change at the recipient site

  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.

  1, 3, and 6 months postoperatively

Secondary Outcomes (2)

• 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

Study Arms (2)

Anterior Palatal Donor Group

EXPERIMENTAL

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.

Procedure: Free Gingival Graft from Anterior Palatal Donor Site

Posterior Palatal / Tuberosity Donor Group

EXPERIMENTAL

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.

Procedure: Free Gingival Graft from Posterior Palatal / Tuberosity Donor Site

Interventions

Free Gingival Graft from Anterior Palatal Donor Site PROCEDURE

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.

Anterior Palatal Donor Group

Free Gingival Graft from Posterior Palatal / Tuberosity Donor Site PROCEDURE

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.

Posterior Palatal / Tuberosity Donor Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hooman Hashemzadeh: lead

Study Sites (1)

Ondokuz Mayis University, Faculty of Dentistry, Department of Periodontology

Samsun, Samsun, 55270, Turkey (Türkiye)

Location

Related Publications (2)

• Parvini P, Galarraga-Vinueza ME, Obreja K, Magini RS, Sader R, Schwarz F. Prospective study assessing three-dimensional changes of mucosal healing following soft tissue augmentation using free gingival grafts. J Periodontol. 2021 Mar;92(3):400-408. doi: 10.1002/JPER.19-0640. Epub 2020 Aug 21.

  PMID: 33448379 BACKGROUND

• Tavelli L, Barootchi S, Siqueira R, Kauffmann F, Majzoub J, Stefanini M, Zucchelli G, Wang HL. Three-Dimensional Volumetric Analysis of the Palatal Donor Site Following Soft Tissue Harvesting. Int J Periodontics Restorative Dent. 2022 May-Jun;42(3):393-399. doi: 10.11607/prd.5268.

  PMID: 35472117 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Tugrul Kirtiloglu, PHD

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

• Emir Akan

  Ondokuz Mayıs University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sub-Investigator, Department of Periodontology

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: December 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)