Soft Tissue Augmentation Around Dental Implants
2026年5月18日 更新者：Andrey Vasilyev
The Use of Collagen Matrices and Connective Tissue Grafts for Soft Tissue Augmentation Around Dental Implants
The goal of this study is to determine which method better increases the volume of soft tissues (gums) around dental implants: using the patient's own tissues or applying collagen matrices. The study also evaluates the safety of these methods and their impact on smile aesthetics.
The main questions it aims to answer:
Which method provides greater and more stable increase in gum thickness around the implant? Does the choice of material affect gum color (how well it matches adjacent areas)? What features of healing and cellular tissue structure are observed when using different materials?
Researchers will compare:
Autogenous connective tissue grafts (CTG) - the patient's own connective tissue grafts harvested from the palate or maxillary tuberosity Xenogeneic collagen matrices (XCM) - bioresorbable materials of animal origin (Fibro-Gide® and FibroMatrix®) that do not require harvesting the patient's own tissue
Participants will:
Undergo a surgical procedure to increase soft tissue volume in the area of implant placement (using one of four methods assigned randomly)
Attend clinic visits for follow-up examinations and assessments:
- Before surgery
- 3 months after surgery
- 6 months after surgery
Undergo additional examinations:
- 3D intraoral scanning to assess changes in tissue volume
- Cone-beam computed tomography (CBCT) to measure gum thickness
- Polarized-light photography to evaluate gum color
- Collection of a small tissue sample (biopsy) for laboratory analysis of tissue structure and cellular composition
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
84
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。
研究場所
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Moscow、ロシア、119021
- Central Research Institute of Dental and Maxillofacial Surgery
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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
いいえ
説明
Inclusion Criteria:
- Age between 21 and 75 years
- Requirement for single dental implant placement in the mandibular molar region (replacing no more than one tooth)
- Need for soft tissue augmentation to achieve peri-implant mucosal thickness ≥2 mm
- Signed voluntary informed consent for treatment and research participation
- Ability and willingness to attend all scheduled follow-up examinations for 12 months post-surgery
- Adequate oral hygiene and commitment to maintain it throughout the study period
Exclusion Criteria:
- Presence of systemic diseases in a decompensated stage (e.g., uncontrolled diabetes, severe cardiovascular disease)
- Current or prior use of immunosuppressants, bisphosphonates, or high-dose corticosteroids
- History of cancer, radiation therapy, or chemotherapy within 5 years prior to enrollment
- Need for concurrent bone grafting or immediate implant placement following tooth extraction
- Active periodontal disease or untreated oral infections at the time of surgery
- Heavy smoking (>10 cigarettes/day) or inability to abstain from smoking during the healing period
- Pregnancy or lactation
- Known allergy to collagen, porcine/bovine products, or materials used in the study (sutures, anesthetics)
- Participation in another clinical trial within 30 days prior to enrollment
- Refusal to participate in any stage of the study or inability to comply with study procedures
- Psychological or social conditions that, in the investigator's judgment, may compromise protocol adherence or data reliability
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Palate CTG
Subepithelial connective tissue graft harvested from the hard palate, placed at the implant site to augment soft tissue thickness and volume
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Autogenous subepithelial connective tissue graft harvested from the hard palate (premolar-molar region) using a horizontal incision 2-3 mm apical to the gingival margin.
Epithelium removed microscopically.
Graft secured within a soft-tissue "envelope" at the recipient implant site using U-shaped sutures.
Donor site closed with compression sutures.
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実験的：Tuberosity CTG
Subepithelial connective tissue graft harvested from the maxillary tuberosity, placed at the implant site to augment soft tissue thickness and volume
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Autogenous subepithelial connective tissue graft harvested from the maxillary tuberosity using parallel incisions 2 mm distal to the last molar.
Epithelial strip removed.
Graft placed and secured at the implant site using U-shaped suturing technique.
Donor site closed with interrupted sutures.
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実験的：Fibro-Gide
Xenogeneic collagen matrix (porcine-derived, types I/III collagen), trimmed and placed between the flap and bone to augment soft tissue
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Porcine-derived xenogeneic collagen matrix (types I/III), 6 mm thick, gamma-sterilized.
Trimmed to fit recipient site, placed between flap and bone without suturing to the flap, fully covered by soft tissues during closure.
No donor site required.
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実験的：FibroMatrix
Xenogeneic collagen matrix (bovine pericardium-derived, types I/III collagen), trimmed and placed between the flap and bone to augment soft tissue
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Bovine pericardium-derived xenogeneic collagen matrix (types I/III), 3-4 mm thick, freeze-dried, bilayer structure.
Trimmed to fit recipient site, placed between flap and bone without suturing to the flap, fully covered by soft tissues during closure.
No donor site required.
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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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Change in peri-implant soft tissue thickness from baseline to 6 months post-augmentation
時間枠：Baseline (pre-surgery), 3 months post-surgery, and 6 months post-surgery
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The primary outcome is the mean change in vertical soft tissue thickness at the implant site, measured at three equidistant points (crest, 1 mm apical, 2 mm apical) along the vestibular aspect of the alveolar ridge.
Thickness is assessed using three complementary methods: (1) mucosal puncture with a calibrated spreader and silicone stopper under local anesthesia; (2) superimposition of cone-beam computed tomography (CBCT) scans; and (3) comparison of digital 3D intraoral scans (STL files) using GOM Inspect software.
Measurements are averaged across the three points per site.
The primary analysis compares mean thickness gain between the four intervention groups (palate CTG, tuberosity CTG, Fibro-Gide, FibroMatrix) at 6 months.
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Baseline (pre-surgery), 3 months post-surgery, and 6 months post-surgery
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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
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 (実際)
2021年10月1日
一次修了 (実際)
2024年10月1日
研究の完了 (実際)
2024年10月1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18日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月22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18日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1/20
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 (IPD) will not be shared publicly.
This decision is based on: (1) the single-center, academic nature of the study with a relatively small sample size, which increases re-identification risk even after de-identification; (2) the inclusion of detailed clinical, radiographic, and histological data that may contain sensitive personal health information; (3) ongoing secondary analyses and manuscript preparations by the investigative team; and (4) the absence of a dedicated infrastructure for secure, governed data sharing at this institution.
医薬品およびデバイス情報、研究文書
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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