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Reharvested Free Gingival Grafts: 3D Shrinkage and Histological Changes

2026년 5월 25일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

관찰

등록 (추정된)

20

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
First free gingival graft
Recipient sites treated with free gingival grafts harvested from the palatal donor site during the initial surgical procedure.
절차: 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.
절차: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
유리치은이식의 3차원적 변화
기간: 기준선
구강 내 디지털 스캐너를 사용하여 이식편의 치수 변경을 평가합니다.
기준선
유리치은이식의 3차원적 변화.
기간: 첫 번째 달
구강 내 디지털 스캐너를 사용하여 이식편의 치수 변경을 평가합니다.
첫 번째 달
The three-dimensional changes of free gingival graft
기간: 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.
기간: 3rd month
An intraoral digital scanner will be used to assess the graft's dimensions alterations.
3rd month
Histological alterations in free gingival grafts
기간: 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
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Keratinized mucosa width
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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,
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Biruni University

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 15일

기본 완료 (추정된)

2027년 6월 15일

연구 완료 (추정된)

2027년 9월 15일

연구 등록 날짜

최초 제출

2026년 5월 18일

QC 기준을 충족하는 최초 제출

2026년 5월 25일

처음 게시됨 (실제)

2026년 6월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 25일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 2024- BİAEK/17-32

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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