Reharvested Free Gingival Grafts: 3D Shrinkage and Histological Changes

NCT07617987 | Not Yet Recruiting

• 1 other identifier: 2024- BİAEK/17-32
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the dimensional stability of free gingival grafts (FGG) and to investigate the relationship between graft shrinkage (GS) and the histological and biochemical characteristics of grafts reharvested from the same palatal donor site. The primary objective is to investigate the relationship between histological alterations in grafts reharvested from the same donor site and graft shrinkage at the recipient site. This study is designed as a split-mouth study in which FGGs are applied to contralateral recipient sites within the same patient. Each participant will receive two grafts: an initial graft harvested from the palatal donor site and a second graft reharvested from the same donor site 63 days after the initial procedure. Graft dimensional changes will be evaluated using three-dimensional digital measurements. Intraoral digital scans will be obtained at baseline, immediately after surgery, and at 1 and 3 months postoperatively. GS will be assessed through superimposition of digital models. In addition, histological, histomorphometric, and immunohistochemical analyses will be performed on tissue samples obtained from the donor site to evaluate collagen characteristics and epithelial structure. Furthermore, protein expression levels of specific markers, including collagen type I, collagen type III, and alpha-smooth muscle actin (α-SMA), will be assessed. Early wound healing at the recipient site will be evaluated using the Landry healing index at postoperative days 7, 14, and 28. In addition, biological mediators, including transforming growth factor beta 1 (TGF-β1), vascular endothelial growth factor A (VEGF-A), and platelet-derived growth factor (PDGF), will be analyzed in wound exudate samples obtained from the recipient site to biochemically assess the early healing process.

Conditions

Insufficient Keratinized Gingiva

Keywords

free gingival graft

Outcome Measures

Primary Outcomes (6)

• The three-dimensional changes of free gingival graft

  An intraoral digital scanner will be used to assess the graft's dimensions alterations.

  Baseline

• The three-dimensional changes of free gingival graft

  An intraoral digital scanner will be used to assess the graft's dimensions alterations.

  Postoperative baseline (immediately after surgery)

• The three-dimensional changes of free gingival graft.

  An intraoral digital scanner will be used to assess the graft's dimensions alterations.

  1st month

• The three-dimensional changes of free gingival graft.

  An intraoral digital scanner will be used to assess the graft's dimensions alterations.

  3rd month

• Histological alterations in free gingival grafts

  Histomorphometric and immunohistochemical evaluation of epithelial thickness and Type I and Type III collagen ratios in free gingival graft samples obtained from the palatal donor site.

  Baseline (initial graft harvesting procedure)

• Histological alterations in re-harvested free gingival grafts

  Histomorphometric and immunohistochemical evaluation of epithelial thickness and Type I and Type III collagen ratios in free gingival graft samples reharvested from the same palatal donor site.

  63 days after the initial surgery (re-harvesting procedure)

Secondary Outcomes (16)

• Keratinized mucosa width

  Baseline (prior to therapy)

• Keratinized mucosa width

  1st month

• Keratinized mucosa width

  3rd month

• Gingival Recession Width

  Baseline (prior to therapy)

• Gingival Recession Width

  1st month

Study Arms (2)

First free gingival graft

Recipient sites treated with free gingival grafts harvested from the palatal donor site during the initial surgical procedure.

Procedure: Free gingival graft

Re-harvested free gingival graft

Recipient sites treated with free gingival grafts re-harvested from the same palatal donor site 63 days after the initial surgery.

Procedure: Re-harvested free gingival graft

Interventions

Free gingival graft PROCEDURE

Following adequate local anesthesia, a horizontal incision will be made at the level of the mucogingival junction to prepare the recipient bed. A split-thickness flap will be elevated without disturbing the periosteum. A free gingival graft will be harvested from the palatal donor site during the initial surgical procedure. The harvested graft will then be transferred to the recipient site, shaped to the desired dimensions, and stabilized with sutures.

First free gingival graft

Re-harvested free gingival graft PROCEDURE

Following adequate local anesthesia, a horizontal incision will be made at the level of the mucogingival junction to prepare the recipient bed. A split-thickness flap will be elevated without disturbing the periosteum. A free gingival graft will be reharvested from the same palatal donor site 63 days after the initial surgery. The harvested graft will then be transferred to the recipient site, shaped to the desired dimensions, and stabilized with sutures.

Re-harvested free gingival graft

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Systemically healthy, non-smoking individuals aged 18-65 years with insufficient keratinized gingiva (\<2 mm; Lang \& Löe, 1972) involving the bilateral mandibular canine and/or premolar regions will be included in the study.

You may qualify if:

• Individuals aged between 18 and 65 years,
• Absence of any systemic disease that may adversely affect periodontal health and wound healing,
• Non-smokers,
• Periodontally healthy individuals,
• Mean plaque index (PI) score \<1 following non-surgical periodontal therapy (NSPT),
• No use of antibiotics or anti-inflammatory drugs within the last 3 months,
• Not being pregnant or breastfeeding,
• Willingness to participate in the study by signing the informed consent form.

You may not qualify if:

• Presence of any systemic disease contraindicating surgical procedures,
• Use of medications or supplements affecting bleeding or wound healing,
• Presence of uncontrolled diabetes mellitus (HbA1c \>7),
• Pregnancy or breastfeeding,
• History of chemotherapy or radiotherapy within the last 6 months,
• History of antibiotic use within the last 3 months,
• Palatal mucosal thickness \<3 mm or presence of palatal torus,
• Presence of deep and narrow (U-shaped) or shallow palatal vaults interfering with palatal measurements,
• Non-compliance with treatment or follow-up protocols.

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

Related Publications (11)

• Keskiner I, Aydogdu A, Balli U, Kaleli AE. Quantitative changes in palatal donor site thickness after free gingival graft harvesting: a pilot study. J Clin Periodontol. 2016 Nov;43(11):976-984. doi: 10.1111/jcpe.12592. Epub 2016 Sep 9.

  PMID: 27330024 BACKGROUND

• Hatipoglu H, Keceli HG, Guncu GN, Sengun D, Tozum TF. Vertical and horizontal dimensional evaluation of free gingival grafts in the anterior mandible: a case report series. Clin Oral Investig. 2007 Jun;11(2):107-13. doi: 10.1007/s00784-006-0084-x. Epub 2007 Feb 9.

  PMID: 17294229 BACKGROUND

• Pippi R. Post-Surgical Clinical Monitoring of Soft Tissue Wound Healing in Periodontal and Implant Surgery. Int J Med Sci. 2017 Jul 18;14(8):721-728. doi: 10.7150/ijms.19727. eCollection 2017.

  PMID: 28824306 BACKGROUND

• Guglielmoni P, Promsudthi A, Tatakis DN, Trombelli L. Intra- and inter-examiner reproducibility in keratinized tissue width assessment with 3 methods for mucogingival junction determination. J Periodontol. 2001 Feb;72(2):134-9. doi: 10.1902/jop.2001.72.2.134.

  PMID: 11288784 BACKGROUND

• Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.

  PMID: 24640997 BACKGROUND

• 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, Stefanini M, Zucchelli G, Giannobile WV, Wang HL. Wound healing dynamics, morbidity, and complications of palatal soft-tissue harvesting. Periodontol 2000. 2023 Jun;92(1):90-119. doi: 10.1111/prd.12466. Epub 2022 Dec 30.

  PMID: 36583690 BACKGROUND

• Gumus P, Buduneli E. Graft stabilization with cyanoacrylate decreases shrinkage of free gingival grafts. Aust Dent J. 2014 Mar;59(1):57-64. doi: 10.1111/adj.12149. Epub 2014 Feb 4.

  PMID: 24494804 BACKGROUND

• Soileau KM, Brannon RB. A histologic evaluation of various stages of palatal healing following subepithelial connective tissue grafting procedures: a comparison of eight cases. J Periodontol. 2006 Jul;77(7):1267-73. doi: 10.1902/jop.2006.050129.

  PMID: 16805692 BACKGROUND

• Silva CO, Ribeiro Edel P, Sallum AW, Tatakis DN. Free gingival grafts: graft shrinkage and donor-site healing in smokers and non-smokers. J Periodontol. 2010 May;81(5):692-701. doi: 10.1902/jop.2010.090381.

  PMID: 20429648 BACKGROUND

• Lang NP, Loe H. The relationship between the width of keratinized gingiva and gingival health. J Periodontol. 1972 Oct;43(10):623-7. doi: 10.1902/jop.1972.43.10.623. No abstract available.

  PMID: 4507712 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Palatal soft tissue samples Wound fluid samples

Study Officials

• Ayşe Ege Selman

  Biruni University, Faculty of Dentistry, Department of Periodontology

  STUDY CHAIR

Central Study Contacts

Ebru Dilmen

CONTACT

+905435673736; 231115001@st.biruni.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 1, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

TU (1)