Clinical and Histological Evaluation of Subepithelial Connective Tissue Graft Maturation at Different Healing Timepoints, With and Without Topical Application of a Polynucleotide- and Hyaluronic Acid-Based Gel
2026年7月13日 更新者：Marcella Kahn、University of Sao Paulo
Clinical and Histological Evaluation of Subepithelial Connective Tissue Graft Maturation at Different Healing Timepoints, With and Without Topical Application of a Polynucleotide- and Hyaluronic Acid-Based Gel: A Randomized, Blinded, Controlled Clinical Trial With a Split-Mouth Design
This study evaluates whether a 9-week healing interval is sufficient for subepithelial connective tissue graft (SCTG) maturation after palatal harvesting, and whether topical application of a polynucleotide and hyaluronic acid gel (Regenfast®) improves tissue quality.
This is a randomized, blinded, controlled clinical trial with a split-mouth design involving 15 participants.
Each participant undergoes bilateral SCTG harvesting from the palate in two surgical sessions 9 weeks apart.
In the first session, one randomized side receives a single topical application of Regenfast® after graft removal; the contralateral side serves as control.
Standardized tissue fragments (3×3 mm, 1.5 mm thickness) are collected from each graft for histological (HE, Picrosirius Red) and immunohistochemical analyses.
Comparisons are made between grafts collected at baseline and after 9 weeks, and between sides treated with or without the gel.
調査の概要
状態
まだ募集していません
詳細な説明
Surgical procedures and sample collections will be performed at Instituto Kahn Odontologia (Rio de Janeiro, Brazil). Laboratory analyses will be conducted at the Histology Laboratory of the School of Dentistry of Ribeirao Preto, University of Sao Paulo (FORP-USP).
SCTG removal will be performed using the double incision technique (Harris, 2003) with a standardized 1.5 mm guide scalpel, under local anesthesia (2% lidocaine, 1:100,000 epinephrine). From each graft, a standardized fragment (3×3 mm, 1.5 mm thickness) will be collected from the distal portion and immediately fixed in 10% buffered formalin for 24-48 hours, then transferred to 70% alcohol.
Laboratory analyses will include: (1) Hematoxylin-eosin (HE) for general morphological assessment; (2) Picrosirius Red under polarized light for quantification of collagen density and proportion of type I and type III collagen fibers; (3) Immunohistochemistry for vascularization assessment, measuring microvessel density (n/mm²) and vascular area (%).
Statistical analysis will use paired Student's t-test or Wilcoxon test for paired samples, depending on data distribution (Shapiro-Wilk test), with significance level of 5% (p<0.05).
研究の種類
介入
入学 (推定)
15
段階
- 適用できない
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：Marcella Kahn, DDS, MS Candidate
- 電話番号：+5521988483846
- メール：mbkahn@usp.br
研究連絡先のバックアップ
- 名前：Michel Reis Messora, DDS, MS, PhD
- メール：m.messora@forp.usp.br
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
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age between 18 and 60 years
- Good general systemic health
- Presence of multiple bilateral gingival recessions with indication for root coverage
Exclusion Criteria:
- Smoking of any intensity
- Pregnancy or lactation
- Oral lesions or alterations in the palatal mucosa
- Previous history of graft harvesting from the donor area
- Continuous use of medications that interfere with the inflammatory response, such as corticosteroids or immunosuppressants
- Autoimmune diseases, coagulation disorders, or other systemic conditions affecting wound healing
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
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Regenfast Gel Application Test Side
Palatal side randomized to receive a single topical application of polynucleotide and hyaluronic acid gel (Regenfast, 0.3 ml) immediately after subepithelial connective tissue graft (SCTG) harvesting in the first surgical session.
The contralateral side receives no intervention.
SCTG is harvested again from the same site after 9 weeks for histological and immunohistochemical analyses.
|
Single topical application of polynucleotide and hyaluronic acid gel (Regenfast, 0.3 ml) to the palatal donor site immediately after subepithelial connective tissue graft harvesting in the first surgical session, before suturing.
Bilateral subepithelial connective tissue graft harvesting from the palatal donor site using the double incision technique (Harris, 2003) with a standardized 1.5 mm guide scalpel, under local anesthesia (2% lidocaine with 1:100,000 epinephrine).
Performed in two surgical sessions with a 9-week interval.
|
|
アクティブコンパレータ：No Intervention - Control Side
Contralateral palatal side receiving no topical intervention after SCTG harvesting in the first surgical session.
SCTG is harvested again from the same site after 9 weeks.
This arm serves as control for both the healing time comparison (baseline vs 9 weeks) and the biomaterial effect comparison.
|
Bilateral subepithelial connective tissue graft harvesting from the palatal donor site using the double incision technique (Harris, 2003) with a standardized 1.5 mm guide scalpel, under local anesthesia (2% lidocaine with 1:100,000 epinephrine).
Performed in two surgical sessions with a 9-week interval.
|
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 |
|---|---|---|
|
Histological Tissue Architecture of the Subepithelial Connective Tissue Graft
時間枠：Baseline and 9 weeks after initial graft harvesting
|
Morphological evaluation of tissue architecture using hematoxylin-eosin (HE) staining, assessing cellular organization, connective tissue maturation, and overall structural quality of grafts harvested at baseline and 9 weeks after initial harvesting, with and without topical application of polynucleotide and hyaluronic acid gel (Regenfast®).
|
Baseline and 9 weeks after initial graft harvesting
|
|
Collagen Density and Fiber Maturation of the Subepithelial Connective Tissue Graft
時間枠：Baseline and 9 weeks after initial graft harvesting
|
Quantification of collagen density and proportion of type I and type III collagen fibers using Picrosirius Red staining under polarized light microscopy, comparing grafts harvested at baseline and 9 weeks after initial harvesting, with and without topical application of polynucleotide and hyaluronic acid gel (Regenfast®).
|
Baseline and 9 weeks after initial graft harvesting
|
|
Microvascular Density and Vascular Area of the Subepithelial Connective Tissue Graft
時間枠：Baseline and 9 weeks after initial graft harvesting
|
Immunohistochemical evaluation of vascularization, assessing microvessel density (number/mm²) and vascular area (%) of grafts harvested at baseline and 9 weeks after initial harvesting, with and without topical application of polynucleotide and hyaluronic acid gel (Regenfast®).
|
Baseline and 9 weeks after initial graft harvesting
|
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
- 主任研究者：Marcella B Kahn, DDS, MS Candidate、Faculdade de Odontologia de Ribeirão Preto, Universidade de São Paulo (FORP-USP)
- スタディチェア：Michel Reis Messora, DDS, MS, PhD、Faculdade de Odontologia de Ribeirão Preto, Universidade de São Paulo (FORP-USP) Role: Study Chair
- スタディディレクター：Sergio Kahn, DDS, MS, PhD、Instituto Kahn Odontologia, Rio de Janeiro
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
- 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.
- Harris RJ. The connective tissue and partial thickness double pedicle graft: a predictable method of obtaining root coverage. J Periodontol. 1992 May;63(5):477-86. doi: 10.1902/jop.1992.63.5.477.
- Pilloni A, Rojas MA, Trezza C, Carere M, De Filippis A, Marsala RL, Marini L. Clinical effects of the adjunctive use of polynucleotide and hyaluronic acid-based gel in the subgingival re-instrumentation of residual periodontal pockets: A randomized, split-mouth clinical trial. J Periodontol. 2023 Mar;94(3):354-363. doi: 10.1002/JPER.22-0225. Epub 2022 Nov 23.
- 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.
- Tavelli L, Barootchi S, Siqueira R, Kauffmann F, Majzoub J, Stefanini M, Zucchelli G, Wang HL. Three-Dimensional Volumetric Analysis of the Palatal Donor Site Following Soft Tissue Harvesting. Int J Periodontics Restorative Dent. 2022 May-Jun;42(3):393-399. doi: 10.11607/prd.5268.
- Harris RJ. Histologic evaluation of connective tissue grafts in humans. Int J Periodontics Restorative Dent. 2003 Dec;23(6):575-83.
- Cairo F, Cavalcanti R, Barbato L, Nieri M, Castelluzzo W, di Martino M, Pilloni A. Polynucleotides and Hyaluronic Acid (PN-HA) Mixture With or Without Deproteinized Bovine Bone Mineral as a Novel Approach for the Treatment of Deep Infrabony Defects: A Retrospective Case Series. Int J Periodontics Restorative Dent. 2025 Mar 6;45(2):153-163. doi: 10.11607/prd.7065.
- Skierska I, Gorski B, Fus L. Tunnel technique and subepithelial connective tissue graft, with or without cross-linked hyaluronic acid, in the treatment of multiple gingival recessions: 12-month outcomes of a randomized clinical trial. J Periodontol. 2024 Nov;95(11):1060-1072. doi: 10.1002/JPER.24-0093. Epub 2024 May 29.
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7月1日
一次修了 (推定)
2026年10月31日
研究の完了 (推定)
2027年2月27日
試験登録日
最初に提出
2026年7月1日
QC基準を満たした最初の提出物
2026年7月13日
最初の投稿 (実際)
2026年7月16日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月16日
QC基準を満たした最後の更新が送信されました
2026年7月13日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 95625625.9.0000.5419 (その他の識別子：Plataforma Brasil)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data will not be shared.
Participant confidentiality is ensured through numerical coding, and all collected data will be used exclusively for scientific purposes within the scope of this study, in accordance with the ethical principles of the Declaration of Helsinki and the approved protocol.
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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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