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Reharvested Free Gingival Grafts: 3D Shrinkage and Histological Changes

25. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

20

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
De tredimensionelle ændringer af frit tandkødstransplantat
Tidsramme: Baseline
En intraoral digital scanner vil blive brugt til at vurdere transplantatets dimensionsændringer.
Baseline
De tredimensionelle ændringer af frit tandkødstransplantat.
Tidsramme: 1. måned
En intraoral digital scanner vil blive brugt til at vurdere transplantatets dimensionsændringer.
1. måned
The three-dimensional changes of free gingival graft
Tidsramme: 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.
Tidsramme: 3rd month
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
3rd month
Histological alterations in free gingival grafts
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Keratinized mucosa width
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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,
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Biruni University

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

15. juni 2027

Studieafslutning (Anslået)

15. september 2027

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

25. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2024- BİAEK/17-32

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