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.
調査の概要
研究の種類
観察的
入学 (推定)
20
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ebru Dilmen
- 電話番号：+905435673736
- メール：231115001@st.biruni.edu.tr
研究場所
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Istanbul、トルコ（Türkiye）
- Biruni University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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遊離歯肉移植片の三次元変化
時間枠：ベースライン
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口腔内デジタル スキャナを使用して、グラフトの寸法変化を評価します。
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ベースライン
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遊離歯肉移植片の三次元変化。
時間枠：1ヶ月目
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口腔内デジタル スキャナを使用して、グラフトの寸法変化を評価します。
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1ヶ月目
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The three-dimensional changes of free gingival graft
時間枠：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.
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Keratinized mucosa width
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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,
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディチェア：Ayşe Ege Selman、Biruni University, Faculty of Dentistry, Department of Periodontology
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月15日
一次修了 (推定)
2027年6月15日
研究の完了 (推定)
2027年9月15日
試験登録日
最初に提出
2026年5月18日
QC基準を満たした最初の提出物
2026年5月25日
最初の投稿 (実際)
2026年6月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月1日
QC基準を満たした最後の更新が送信されました
2026年5月25日
最終確認日
2026年5月1日
詳しくは
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キーワード
その他の研究ID番号
- 2024- BİAEK/17-32
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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