Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07617987

Reharvested Free Gingival Grafts: 3D Shrinkage and Histological Changes

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Insufficient Keratinized Gingiva

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Biruni University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ebru Dilmen

CONTACT

[email protected]

+905435673736

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.