Peri-Implant Soft Tissue Augmentation Using a Free Connective Tissue Graft With an Epithelial Collar
2026年5月29日 更新者：I.M. Sechenov First Moscow State Medical University
Application of a Free Connective Tissue Graft With an Epithelial Collar for Peri-Implant Soft Tissue Augmentation in Patients With Soft Tissue Deficiency Around Dental Implants
A prospective randomized interventional clinical trial (RCT) with a parallel-group design is planned.
The study sample will include 32 patients randomly allocated into two groups according to the surgical intervention performed.
In the first group, a free connective tissue graft with an epithelial collar will be used.
In the second group, a free connective tissue graft without an epithelial collar will be used.
In the postoperative period, assessment of changes in the width of keratinized mucosa, soft tissue thickness, pain severity, postoperative swelling, and patient quality of life will be performed.
調査の概要
状態
積極的、募集していない
条件
詳細な説明
The aim of this study is to perform a comparative analysis of the effectiveness of free connective tissue grafts with and without an epithelial collar for peri-implant soft tissue augmentation. Examination and treatment of patients will be carried out at the Department of Oral Surgery of the E.V. Borovsky Institute of Dentistry, Sechenov University.
The study population will include patients with bounded or distal edentulous defects of the upper or lower jaw combined with soft tissue thickness deficiency around dental implants (<2 mm), requiring peri-implant soft tissue augmentation using a free connective tissue graft.
All patients will be randomly allocated into two groups according to the surgical intervention method. In the first group (n=16), a free connective tissue graft without an epithelial collar will be used, while in the second group (n=16), a free connective tissue graft with an epithelial collar will be used. The groups will be comparable in terms of age and sex characteristics.
Patient randomization will be performed intraoperatively as follows: after dental implant placement and preparation of the recipient site, an envelope containing the randomly assigned treatment method will be opened. Patients in both groups will undergo dental implant placement according to the standard surgical protocol combined with peri-implant soft tissue augmentation.
A mucosal incision will be performed followed by elevation of a mucoperiosteal flap, preparation of the implant bed, and placement of the dental implant. Subsequently, the recipient site will be prepared and a free connective tissue graft harvested from the maxillary tuberosity or palatal area. Depending on the allocated group, a graft with or without an epithelial collar will be used. The graft will be fixed to the mucoperiosteal flap, followed by tension-free wound closure, while the donor site will be closed primarily.
In the postoperative period, standard antibacterial and anti-inflammatory therapy combined with topical antiseptic agents will be prescribed.
研究の種類
介入
入学 (実際)
32
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
- I.M. Sechenov First Moscow State Medical University (Sechenov 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
健康ボランティアの受け入れ
はい
説明
- Written informed consent for participation in the study;
- Age between 18 and 45 years;
- Bounded edentulous defects of the upper or lower jaw involving 1-2 teeth combined with soft tissue thickness deficiency around dental implants (<2 mm);
- Teeth without periodontal pathology, with probing depth not exceeding 3 mm throughout the gingival sulcus;
- Satisfactory level of oral hygiene;
- Absence of systemic diseases in the stage of exacerbation or decompensation.
Non-inclusion criteria:
- Patients who previously underwent connective tissue graft harvesting from the same donor site;
- Patients with impacted third molars in the donor site area;
- Presence of concomitant diseases in the stage of exacerbation or decompensation;
- Patients with malignant neoplasms, as well as patients who underwent radiation therapy or chemotherapy within the previous 5 years;
- Patients with a smoking history of more than 10 years.
Exclusion Criteria:
- Patient refusal to continue participation in the study;
- Pregnant or breastfeeding women;
- Patients with coagulation disorders (hemophilia, von Willebrand disease, or anticoagulant therapy);
- Patients with diseases affecting soft tissue healing processes (insulin-dependent diabetes mellitus).
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：first group
Patients will receive a free connective tissue graft without an epithelial collar
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実験的：second group
Patients will receive a free connective tissue graft with epithelial collar
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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 |
|---|---|---|
|
Change in the Width of Keratinized Mucosa
時間枠：Day 90 compared to the 0th day (initial value)
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Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by digital scanning before surgery and on postoperative day 90.
Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points.
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Day 90 compared to the 0th day (initial value)
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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 |
|---|---|---|
|
Change in the Width of Keratinized Mucosa
時間枠：Day 180 compared to the 0th day (initial value)
|
Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by laboratory scanning before surgery and on postoperative day 180.
Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points.
|
Day 180 compared to the 0th day (initial value)
|
|
Assessment of Scar Formation According to the Modified Scar Index (MSI)
時間枠：Day 90 compared to the 0th day (initial value)
|
Assessment of postoperative soft tissue scar quality around dental implants is performed using the Modified Scar Index (MSI) according to Mombelli et al., based on the evaluation of five parameters: scar color, scar contour, soft tissue deformity, scar tissue texture, and wound margin separation.
Each parameter is assessed using a 3-point scale, where: 0 = optimal tissue condition; 1 = moderate scar changes; 2 = pronounced scar changes.
The total MSI score ranges from 0 to 10, with lower scores indicating better clinical outcomes and minimal scar formation.
Clinical assessment is performed visually and by palpation, with additional evaluation using clinical photographs when necessary.
|
Day 90 compared to the 0th day (initial value)
|
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Assessment of Scar Formation According to the Modified Scar Index (MSI)
時間枠：Day 180 compared to the 0th day (initial value)
|
Assessment of postoperative soft tissue scar quality around dental implants is performed using the Modified Scar Index (MSI) according to Mombelli et al., based on the evaluation of five parameters: scar color, scar contour, soft tissue deformity, scar tissue texture, and wound margin separation.
Each parameter is assessed using a 3-point scale, where: 0 = optimal tissue condition; 1 = moderate scar changes; 2 = pronounced scar changes.
The total MSI score ranges from 0 to 10, with lower scores indicating better clinical outcomes and minimal scar formation.
Clinical assessment is performed visually and by palpation, with additional evaluation using clinical photographs when necessary.
|
Day 180 compared to the 0th day (initial value)
|
|
Assessment of Pain Severity
時間枠：4 hours compared to the 0th day (initial value)
|
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
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4 hours compared to the 0th day (initial value)
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Assessment of Pain Severity
時間枠：Day 1 compared to the 0th day (initial value)
|
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
|
Day 1 compared to the 0th day (initial value)
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Assessment of Pain Severity
時間枠：Day 3 compared to the 0th day (initial value)
|
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
|
Day 3 compared to the 0th day (initial value)
|
|
Assessment of Pain Severity
時間枠：Day 5 compared to the 0th day (initial value)
|
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
|
Day 5 compared to the 0th day (initial value)
|
|
Assessment of Pain Severity
時間枠：Day 7 compared to the 0th day (initial value)
|
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
|
Day 7 compared to the 0th day (initial value)
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Assessment of Postoperative Swelling Severity
時間枠：Day 1 compared to the 0th day (initial value)
|
Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
|
Day 1 compared to the 0th day (initial value)
|
|
Assessment of Postoperative Swelling Severity
時間枠：Day 3 compared to the 0th day (initial value)
|
Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
|
Day 3 compared to the 0th day (initial value)
|
|
Assessment of Postoperative Swelling Severity
時間枠：Day 5 compared to the 0th day (initial value)
|
Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
|
Day 5 compared to the 0th day (initial value)
|
|
Assessment of Postoperative Swelling Severity
時間枠：Day 7 compared to the 0th day (initial value)
|
Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
|
Day 7 compared to the 0th day (initial value)
|
|
Assessment of Bleeding
時間枠：Day 1 compared to the 0th day (initial value)
|
Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
|
Day 1 compared to the 0th day (initial value)
|
|
Assessment of Bleeding
時間枠：Day 3 compared to the 0th day (initial value)
|
Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
|
Day 3 compared to the 0th day (initial value)
|
|
Assessment of Bleeding
時間枠：Day 5 compared to the 0th day (initial value)
|
Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
|
Day 5 compared to the 0th day (initial value)
|
|
Assessment of Bleeding
時間枠：Day 7 compared to the 0th day (initial value)
|
Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
|
Day 7 compared to the 0th day (initial value)
|
|
Assessment of Analgesic Intake
時間枠：Day 1 compared to the 0th day (initial value)
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Assessment of the number of Nimesulide 100 mg tablets taken per day.
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Day 1 compared to the 0th day (initial value)
|
|
Assessment of Analgesic Intake
時間枠：Day 3 compared to the 0th day (initial value)
|
Assessment of the number of Nimesulide 100 mg tablets taken per day.
|
Day 3 compared to the 0th day (initial value)
|
|
Assessment of Analgesic Intake
時間枠：Day 5 compared to the 0th day (initial value)
|
Assessment of the number of Nimesulide 100 mg tablets taken per day.
|
Day 5 compared to the 0th day (initial value)
|
|
Assessment of Analgesic Intake
時間枠：Day 7 compared to the 0th day (initial value)
|
Assessment of the number of Nimesulide 100 mg tablets taken per day.
|
Day 7 compared to the 0th day (initial value)
|
|
Quality of Life Assessment According to OHIP-14
時間枠：Day 0 (initial value)
|
Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
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Day 0 (initial value)
|
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Quality of Life Assessment According to OHIP-14
時間枠：Day 7 compared to the 0th day (initial value)
|
Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
|
Day 7 compared to the 0th day (initial value)
|
|
Quality of Life Assessment According to OHIP-14
時間枠：Day 90-93 compared to the 0th day (initial value)
|
Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
|
Day 90-93 compared to the 0th day (initial value)
|
|
Quality of Life Assessment According to OHIP-14
時間枠：Day 180-186 compared to the 0th day (initial value)
|
Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
|
Day 180-186 compared to the 0th day (initial value)
|
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。
捜査官
- 主任研究者：Igor P Ashurko、I.M. Sechenov First Moscow State Medical University (Sechenov University)
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)
2024年6月20日
一次修了 (推定)
2026年6月20日
研究の完了 (推定)
2026年8月20日
試験登録日
最初に提出
2026年5月29日
QC基準を満たした最初の提出物
2026年5月29日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4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29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
キーワード
その他の研究ID番号
- AI-05
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いいえ
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いいえ
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いいえ
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