Reharvested Free Gingival Grafts: 3D Shrinkage and Histological Changes

Official title

Three-Dimensional Assessment of Graft Shrinkage in Relation to Histological Alterations in Reharvested Free Gingival Grafts From the Same Palatal Donor Site

Overview

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.

Interventions

• Procedure Free gingival graft
  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.
• Procedure Re-harvested free gingival graft
  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.

Primary outcome measures

• The three-dimensional changes of free gingival graft [Time frame: Baseline]
• The three-dimensional changes of free gingival graft [Time frame: Postoperative baseline (immediately after surgery)]
• The three-dimensional changes of free gingival graft. [Time frame: 1st month]
• The three-dimensional changes of free gingival graft. [Time frame: 3rd month]
• Histological alterations in free gingival grafts [Time frame: Baseline (initial graft harvesting procedure)]
• Histological alterations in re-harvested free gingival grafts [Time frame: 63 days after the initial surgery (re-harvesting procedure)]

Secondary outcome measures (12)

• Keratinized mucosa width [Time frame: Baseline (prior to therapy)]
• Keratinized mucosa width [Time frame: 1st month]
• Keratinized mucosa width [Time frame: 3rd month]
• Gingival Recession Width [Time frame: Baseline (prior to therapy)]
• Gingival Recession Width [Time frame: 1st month]
• Gingival Recession Width [Time frame: 3rd month]
• Gingival Thickness [Time frame: Baseline]
• Gingival Thickness [Time frame: 3rd month]
• Landry Healing Index [Time frame: 7th day]
• Landry Healing Index [Time frame: 14th day]
• Landry Healing Index [Time frame: 28th day]
• Growth factor levels in wound fluid [Time frame: 3rd day]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Other

Study locations

Turkey (Türkiye) · 1 center

• Biruni University — Istanbul

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07617987 · 2024- BİAEK/17-32

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗