Reharvested Free Gingival Grafts: 3D Shrinkage and Histological Changes
2026年5月25日 更新者：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.
研究概览
研究类型
观察性的
注册 (估计的)
20
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ebru Dilmen
- 电话号码：+905435673736
- 邮箱：231115001@st.biruni.edu.tr
学习地点
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Istanbul、土耳其（türkiye）
- Biruni University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
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.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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First free gingival graft
Recipient sites treated with free gingival grafts harvested from the palatal donor site during the initial surgical procedure.
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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.
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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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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游离龈移植物的三维变化
大体时间：基线
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口内数字扫描仪将用于评估移植物的尺寸变化。
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基线
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游离龈移植物的三维变化。
大体时间：第 1 个月
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口内数字扫描仪将用于评估移植物的尺寸变化。
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第 1 个月
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The three-dimensional changes of free gingival graft
大体时间：Postoperative baseline (immediately after surgery)
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An intraoral digital scanner will be used to assess the graft's dimensions alterations.
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Postoperative baseline (immediately after surgery)
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The three-dimensional changes of free gingival graft.
大体时间：3rd month
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An intraoral digital scanner will be used to assess the graft's dimensions alterations.
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3rd month
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Histological alterations in free gingival grafts
大体时间：Baseline (initial graft harvesting procedure)
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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.
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Baseline (initial graft harvesting procedure)
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Histological alterations in re-harvested free gingival grafts
大体时间：63 days after the initial surgery (re-harvesting procedure)
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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.
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63 days after the initial surgery (re-harvesting procedure)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Keratinized mucosa width
大体时间：Baseline (prior to therapy)
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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.
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Baseline (prior to therapy)
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Keratinized mucosa width
大体时间：1st month
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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.
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1st month
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Keratinized mucosa width
大体时间：3rd month
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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.
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3rd month
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Gingival Recession Width
大体时间：Baseline (prior to therapy)
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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.
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Baseline (prior to therapy)
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Gingival Recession Width
大体时间：1st month
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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.
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1st month
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Gingival Recession Width
大体时间：3rd month
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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.
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3rd month
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Gingival Thickness
大体时间：Baseline
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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.
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Baseline
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Gingival Thickness
大体时间：3rd month
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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.
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3rd month
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Landry Healing Index
大体时间：7th day
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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.
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7th day
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Landry Healing Index
大体时间：14th day
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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.
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14th day
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Landry Healing Index
大体时间：28th day
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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.
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28th day
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Growth factor levels in wound fluid
大体时间：3rd day
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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.
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3rd day
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Growth factor levels in wound fluid
大体时间：7th day
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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.
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7th day
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Protein expression levels in free gingival grafts,
大体时间：Baseline (initial graft harvesting procedure)
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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.
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Baseline (initial graft harvesting procedure)
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Protein expression levels in free gingival grafts
大体时间：63 days after the initial surgery (re-harvesting procedure)
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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.
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63 days after the initial surgery (re-harvesting procedure)
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Patient reported outcomes
大体时间：10th day
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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.
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10th day
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Ayşe Ege Selman、Biruni University, Faculty of Dentistry, Department of Periodontology
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.
- Lang NP, Loe H. The relationship between the width of keratinized gingiva and gingival health. J Periodontol. 1972 Oct;43(10):623-7. doi: 10.1902/jop.1972.43.10.623. No abstract available.
- Guglielmoni P, Promsudthi A, Tatakis DN, Trombelli L. Intra- and inter-examiner reproducibility in keratinized tissue width assessment with 3 methods for mucogingival junction determination. J Periodontol. 2001 Feb;72(2):134-9. doi: 10.1902/jop.2001.72.2.134.
- Soileau KM, Brannon RB. A histologic evaluation of various stages of palatal healing following subepithelial connective tissue grafting procedures: a comparison of eight cases. J Periodontol. 2006 Jul;77(7):1267-73. doi: 10.1902/jop.2006.050129.
- Pippi R. Post-Surgical Clinical Monitoring of Soft Tissue Wound Healing in Periodontal and Implant Surgery. Int J Med Sci. 2017 Jul 18;14(8):721-728. doi: 10.7150/ijms.19727. eCollection 2017.
- Parvini P, Galarraga-Vinueza ME, Obreja K, Magini RS, Sader R, Schwarz F. Prospective study assessing three-dimensional changes of mucosal healing following soft tissue augmentation using free gingival grafts. J Periodontol. 2021 Mar;92(3):400-408. doi: 10.1002/JPER.19-0640. Epub 2020 Aug 21.
- Tavelli L, Barootchi S, Stefanini M, Zucchelli G, Giannobile WV, Wang HL. Wound healing dynamics, morbidity, and complications of palatal soft-tissue harvesting. Periodontol 2000. 2023 Jun;92(1):90-119. doi: 10.1111/prd.12466. Epub 2022 Dec 30.
- Silva CO, Ribeiro Edel P, Sallum AW, Tatakis DN. Free gingival grafts: graft shrinkage and donor-site healing in smokers and non-smokers. J Periodontol. 2010 May;81(5):692-701. doi: 10.1902/jop.2010.090381.
- Hatipoglu H, Keceli HG, Guncu GN, Sengun D, Tozum TF. Vertical and horizontal dimensional evaluation of free gingival grafts in the anterior mandible: a case report series. Clin Oral Investig. 2007 Jun;11(2):107-13. doi: 10.1007/s00784-006-0084-x. Epub 2007 Feb 9.
- Keskiner I, Aydogdu A, Balli U, Kaleli AE. Quantitative changes in palatal donor site thickness after free gingival graft harvesting: a pilot study. J Clin Periodontol. 2016 Nov;43(11):976-984. doi: 10.1111/jcpe.12592. Epub 2016 Sep 9.
- Gumus P, Buduneli E. Graft stabilization with cyanoacrylate decreases shrinkage of free gingival grafts. Aust Dent J. 2014 Mar;59(1):57-64. doi: 10.1111/adj.12149. Epub 2014 Feb 4.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月15日
初级完成 (估计的)
2027年6月15日
研究完成 (估计的)
2027年9月15日
研究注册日期
首次提交
2026年5月18日
首先提交符合 QC 标准的
2026年5月25日
首次发布 (实际的)
2026年6月1日
研究记录更新
最后更新发布 (实际的)
2026年6月1日
上次提交的符合 QC 标准的更新
2026年5月25日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.