Reharvested Free Gingival Grafts: 3D Shrinkage and Histological Changes

May 25, 2026 updated by: Ayse Ege SELMAN, Biruni University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The three-dimensional changes of free gingival graft
Time Frame: Baseline
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
Baseline
The three-dimensional changes of free gingival graft.
Time Frame: 1st month
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
1st month
The three-dimensional changes of free gingival graft
Time Frame: Postoperative baseline (immediately after surgery)
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.
Time Frame: 3rd month
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
3rd month
Histological alterations in free gingival grafts
Time Frame: Baseline (initial graft harvesting procedure)
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
Time Frame: 63 days after the initial surgery (re-harvesting procedure)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized mucosa width
Time Frame: Baseline (prior to therapy)
The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on tooth (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.
Baseline (prior to therapy)
Keratinized mucosa width
Time Frame: 1st month
The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on tooth (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.
1st month
Keratinized mucosa width
Time Frame: 3rd month
The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on tooth (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.
3rd month
Gingival Recession Width
Time Frame: Baseline (prior to therapy)
The widest horizontal distance between the mesial and distal gingival margins of the recession defect at the level of the cementoenamel junction (CEJ) will be measured using a periodontal probe held horizontally.
Baseline (prior to therapy)
Gingival Recession Width
Time Frame: 1st month
The widest horizontal distance between the mesial and distal gingival margins of the recession defect at the level of the cementoenamel junction (CEJ) will be measured using a periodontal probe held horizontally.
1st month
Gingival Recession Width
Time Frame: 3rd month
The widest horizontal distance between the mesial and distal gingival margins of the recession defect at the level of the cementoenamel junction (CEJ) will be measured using a periodontal probe held horizontally.
3rd month
Gingival Thickness
Time Frame: Baseline
Following local anesthesia, measurements will be performed at the distobuccal, midbuccal, and mesiobuccal aspects of the teeth in the recipient area by inserting a #20 spreader with a silicone stopper perpendicular to the gingival surface, 2 mm apical to the gingival margin. After hard tissue contact is achieved, the distance between the tip of the spreader and the silicone stopper will be measured using a digital caliper. The mean value of the measurements will be recorded.
Baseline
Gingival Thickness
Time Frame: 3rd month
Following local anesthesia, measurements will be performed at the distobuccal, midbuccal, and mesiobuccal aspects of the teeth in the recipient area by inserting a #20 spreader with a silicone stopper perpendicular to the gingival surface, 2 mm apical to the gingival margin. After hard tissue contact is achieved, the distance between the tip of the spreader and the silicone stopper will be measured using a digital caliper. The mean value of the measurements will be recorded.
3rd month
Landry Healing Index
Time Frame: 7th day
Healing at the recipient site will be evaluated according to tissue color, presence of bleeding and granulation tissue, suppuration, and epithelialization. Healing will be scored on a scale ranging from 1 to 5.
7th day
Landry Healing Index
Time Frame: 14th day
Healing at the recipient site will be evaluated according to tissue color, presence of bleeding and granulation tissue, suppuration, and epithelialization. Healing will be scored on a scale ranging from 1 to 5.
14th day
Landry Healing Index
Time Frame: 28th day
Healing at the recipient site will be evaluated according to tissue color, presence of bleeding and granulation tissue, suppuration, and epithelialization. Healing will be scored on a scale ranging from 1 to 5.
28th day
Growth factor levels in wound fluid
Time Frame: 3rd day
Wound fluid samples will be collected from the mesiocoronal, distocoronal, mesioapical, and distoapical margins of the surgical recipient site using paper strips (Periopaper®, Oraflow, Plainview, NY, USA). The strips will be gently placed at the relevant sites for 30 seconds while avoiding mechanical trauma. VEGF-A, PDGF, and TGF-β1 levels will be evaluated.
3rd day
Growth factor levels in wound fluid
Time Frame: 7th day
Wound fluid samples will be collected from the mesiocoronal, distocoronal, mesioapical, and distoapical margins of the surgical recipient site using paper strips (Periopaper®, Oraflow, Plainview, NY, USA). The strips will be gently placed at the relevant sites for 30 seconds while avoiding mechanical trauma. VEGF-A, PDGF, and TGF-β1 levels will be evaluated.
7th day
Protein expression levels in free gingival grafts,
Time Frame: Baseline (initial graft harvesting procedure)
Biochemical evaluation of type I collagen, type III collagen, and α-SMA protein expression levels in free gingival graft samples obtained from the donor site.
Baseline (initial graft harvesting procedure)
Protein expression levels in free gingival grafts
Time Frame: 63 days after the initial surgery (re-harvesting procedure)
Biochemical evaluation of type I collagen, type III collagen, and α-SMA protein expression levels in free gingival graft samples obtained from the same donor site.
63 days after the initial surgery (re-harvesting procedure)
Patient reported outcomes
Time Frame: 10th day
After the surgical procedure, patients will be asked to complete a form consisting of 3 items: (1) assessment of the intensity of postoperative pain/discomfort (by Visual Analog Scale), (2) duration of pain (in days) and (3) number of analgesic tablets taken.
10th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biruni University

Investigators

  • Study Chair: Ayşe Ege Selman, Biruni University, Faculty of Dentistry, Department of Periodontology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

September 15, 2027

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

May 25, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024- BİAEK/17-32

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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