Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Reharvested Free Gingival Grafts: 3D Shrinkage and Histological Changes

25 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

20

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
First free gingival graft
Recipient sites treated with free gingival grafts harvested from the palatal donor site during the initial surgical procedure.
Procédure: 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.
Procédure: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Les changements tridimensionnels de la greffe gingivale libre
Délai: Référence
Un scanner numérique intra-oral sera utilisé pour évaluer les modifications dimensionnelles du greffon.
Référence
Les changements tridimensionnels de la greffe gingivale libre.
Délai: 1er mois
Un scanner numérique intra-oral sera utilisé pour évaluer les modifications dimensionnelles du greffon.
1er mois
The three-dimensional changes of free gingival graft
Délai: 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.
Délai: 3rd month
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
3rd month
Histological alterations in free gingival grafts
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Keratinized mucosa width
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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,
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Biruni University

Les enquêteurs

  • Chaise d'étude: Ayşe Ege Selman, Biruni University, Faculty of Dentistry, Department of Periodontology

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 juin 2026

Achèvement primaire (Estimé)

15 juin 2027

Achèvement de l'étude (Estimé)

15 septembre 2027

Dates d'inscription aux études

Première soumission

18 mai 2026

Première soumission répondant aux critères de contrôle qualité

25 mai 2026

Première publication (Réel)

1 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 2024- BİAEK/17-32

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner