Effect of Collagen Membrane on Ridge Preservation
2026年6月2日 更新者：Debora Dias
Effect of Collagen Membrane on Ridge Preservation for Delayed Implant Placement in Sites With Absent Buccal Bone Wall: A Randomized Controlled Trial
This study will evaluate whether adding a resorbable collagen membrane to an anorganic bone-collagen composite (ABCC) graft improves ridge preservation after tooth extraction. Ridge preservation is a procedure used to maintain the shape and volume of the jawbone following tooth removal, which is important for future dental implant placement.
Participants will be randomly assigned to receive either ABCC alone or ABCC combined with a collagen membrane. Healing outcomes will be assessed after approximately 4 months using three-dimensional cone beam computed tomography (CBCT) scans.
The primary outcome is the change in horizontal ridge dimension (width). Secondary outcomes include vertical and contour changes in ridge dimensions, changes in soft tissue contour assessed with digital scans, postoperative healing and complications (such as wound dehiscence, swelling, or infection), and patient-reported outcomes, including pain and satisfaction. In a subset of participants, bone healing will also be evaluated using laboratory and imaging analyses of bone samples obtained at the time of implant placement. The study will additionally assess whether the treatment allows implant placement in the ideal position without the need for further bone grafting.
調査の概要
状態
募集
詳細な説明
This study is a clinical trial that evaluates two different approaches to preserve the jawbone after tooth extraction in areas where part of the bone is already missing. Preserving the bone is important to support future dental implants.
Participants will be randomly assigned (like flipping a coin) to receive one of two treatments: a bone graft material alone, or the same bone graft combined with a protective collagen membrane placed over it.
Tooth extraction and follow-up care will be performed in the same manner for all participants. After approximately 4 months of healing, participants will return for dental implant placement.
During the healing period and at the time of implant placement, the research team will evaluate how well the bone and gums have healed. This will include three-dimensional CBCT scans, digital intraoral scans, and clinical measurements. In some participants, a small sample of bone will be collected at the time of implant placement to study bone healing.
The study will compare how effectively each treatment maintains the shape and volume of the jawbone, the quality of soft tissue healing, the risk of complications, patient-reported outcomes (PROs), including comfort and satisfaction, and whether additional procedures are required prior to implant placement.
研究の種類
介入
入学 (推定)
30
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：Carla Sanchez, MS
- 電話番号：4126241179
- メール：cab28@pitt.edu
研究連絡先のバックアップ
- 名前：Debora R Dias, DDS, PhD
- 電話番号：4126488595
- メール：deboradias@pitt.edu
研究場所
-
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- 募集
- University of Pittsburgh School of Dental Medicine, Department of Periodontics and Preventive Dentistry
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コンタクト：
- Andrea Ravida, DDS, PhD
- 電話番号：7347309678
- メール：andrearavida@pitt.edu
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主任研究者：
- Debora R Dias, DDS, PhD
-
コンタクト：
- Debora R Dias, DDS, PhD
- 電話番号：412-648-8595
- メール：deboradias@pitt.edu
-
-
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:
- Adults aged 18-80
- Indicated for extraction of a single-rooted maxillary tooth
- ≥ 50% buccal bone dehiscence confirmed by CBCT reconstructions
- Presence of both adjacent teeth
- No interproximal bone loss
- ASA I-II health status
- Ability to comply with required procedures, including attending required number of clinic visits
Exclusion Criteria:
- Patients diagnosed with periodontitis adjacent to the area to be treated
- History of allergic reactions to local anesthetics or bone graft material (self-reported);
- Current heavy smokers (≥ 10 cigarettes/day) or those who quit smoking recently (self-reported; last 6 months);
- Diagnosis of diabetes mellitus, liver or kidney failure (self-reported);
- Presence of active infectious diseases of any kind;
- History of chemotherapy or radiation therapy to the head or neck within the past 5 years (self-reported);
- Severe hematologic disorders (risk for hemorrhage)(self-reported);
- Assumption of corticosteroids, IV bisphosphonates or immunosuppressive drugs;
- Any history of alcohol or drug abuse (self-reported);
- Pregnancy or plans to become pregnant within 4 months of study enrollment (self-reported);
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Control group (bone graft only)
Control group (bone graft only): The socket will be grafted with ABCC alone.
The socket entrance will be covered with a collagen sponge, which will be secured with passive cross-mattress polytetrafluoroethylene sutures (PTFE) without attempting primary closure.
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Tooth extraction will be performed by a calibrated periodontist using a minimally invasive, flapless, atraumatic technique with periotomes and elevators to preserve socket architecture.
Granulation tissue will be carefully removed without flap elevation.
The extraction socket will be grafted with ABCC (SigmaGraft®).
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実験的：Test group (bone graft + collagen membrane)
Test group (bone graft + collagen membrane): A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate the resorbable collagen membrane (InterCollagen® Guide, SigmaGraft).
The socket will then be grafted with ABCC.
The socket entrance will be covered with a collagen sponge, which will be secured with passive cross-mattress PTFE sutures without attempting primary closure.
|
Tooth extraction will be performed by a calibrated periodontist using a minimally invasive, flapless, atraumatic technique with periotomes and elevators to preserve socket architecture.
Granulation tissue will be carefully removed without flap elevation.
The extraction socket will be grafted with ABCC (SigmaGraft®).
A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate a resorbable collagen membrane (InterCollagen® Guide; SigmaGraft®).
The membrane will be positioned in the buccal tunnel to replace the missing buccal bone wall and provide graft containment.
|
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 |
|---|---|---|
|
Horizontal dimensional changes (%)
時間枠：Baseline and 4 months
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Change in horizontal ridge width at 3 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
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Baseline and 4 months
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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 |
|---|---|---|
|
Horizontal dimensional changes (%)
時間枠：Baseline and 4 months
|
Change in horizontal ridge width at 1 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
|
Baseline and 4 months
|
|
Horizontal dimensional changes (%)
時間枠：Baseline and 4 months
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Change in horizontal ridge width at 5 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
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Baseline and 4 months
|
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Vertical dimensional changes (%)
時間枠：Baseline and 4 months
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Change in vertical ridge height at the midbuccal aspect, measured on CBCT scans and expressed in percentage change.
|
Baseline and 4 months
|
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Vertical dimensional changes (%)
時間枠：Baseline and 4 months
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Change in vertical ridge height at the mid palatal aspect, measured on CBCT scans and expressed in percentage change.
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Baseline and 4 months
|
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Volumetric dimensional changes (%)
時間枠：Baseline and 4 months
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Change in the volume of the alveolar process (mm3), measured on CBCT scans in comparison to baseline and expressed in percentage change.
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Baseline and 4 months
|
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Mid-buccal soft tissue contour change (mm)
時間枠：Baseline and 4 months
|
Linear measurement (mm) of mid-buccal soft tissue profile change assessed by superimposition of stereolithography (STL) datasets.
Adjacent teeth are used as reference for alignment.
A positive value indicates soft tissue gain; a negative value indicates recession.
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Baseline and 4 months
|
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Mid-buccal soft tissue volume change (%)
時間枠：Baseline and 4 months
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Volumetric change (mm³) in mid-buccal soft tissue contour calculated by superimposition of STL datasets and expressed in percentage.
Color-coded deviation maps will illustrate areas of soft tissue collapse or gain.
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Baseline and 4 months
|
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Interproximal papilla height change (mm)
時間枠：Baseline and 4 months
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Linear measurement (mm) of interproximal papilla height change assessed by superimposition of STL datasets in comparison to baseline.
A positive value indicates papilla gain; a negative value indicates papilla loss.
|
Baseline and 4 months
|
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Wound healing (Wound Healing Index)
時間枠：1 week, 2 weeks, 1 month, 4 months
|
Wound healing quality assessed using the Wound Healing Index (WHI), a 3-point ordinal scale where 1 = uneventful healing (complete soft tissue coverage, no complications), 2 = normal healing with minor complications, and 3 = poor healing (dehiscence, exposure, or infection requiring intervention).
Lower scores indicate better healing.
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1 week, 2 weeks, 1 month, 4 months
|
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Incidence of postoperative complications (Percentage)
時間枠：1 week, 2 weeks, 1 month, 4 months
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Proportion of participants experiencing at least one postoperative complication (edema, erythema, suppuration, graft exposure, or wound dehiscence) at any follow-up visit.
Complications will be recorded by a blinded clinical examiner at each scheduled visit.
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1 week, 2 weeks, 1 month, 4 months
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Postoperative pain
時間枠：Day 1, Day 3, 1 week
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Numeric scale (0-10) for pain after the extraction and ridge preservation procedure.
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Day 1, Day 3, 1 week
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Oral health-related quality of life (OHIP-14)
時間枠：Baseline, 2 weeks, 4 months
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Oral health-related quality of life assessed using the Oral Health Impact Profile - 14 (OHIP-14), a validated 14-item questionnaire.
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Baseline, 2 weeks, 4 months
|
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Feasibility of prosthetically ideal implant placement without additional augmentation
時間枠：4 months
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Ability to place the implant in a prosthetically ideal three-dimensional position at reentry without the need for additional hard-tissue augmentation.
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4 months
|
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Histological Outcomes
時間枠：4 months
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In a subset of patients, a bone core biopsy will be obtained.
Percent area of new bone, residual graft, and marrow spaces assessed by histomorphometric analysis of bone core biopsies obtained at the time of implant placement.
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4 months
|
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Patient satisfaction (VAS)
時間枠：4 months
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Visual analogue scale (0-100) of patient satisfaction with the appearance of the soft tissues
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4 months
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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
協力者
捜査官
- 主任研究者：Debora R Dias, DDS, PhD、University of Pittsburgh, Department of Periodontics and Preventive Dentistry
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
- Thoma DS, Zeltner M, Hilbe M, Hammerle CH, Husler J, Jung RE. Randomized controlled clinical study evaluating effectiveness and safety of a volume-stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites. J Clin Periodontol. 2016 Oct;43(10):874-85. doi: 10.1111/jcpe.12588. Epub 2016 Aug 12.
- Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
- Hutton CG, Johnson GK, Barwacz CA, Allareddy V, Avila-Ortiz G. Comparison of two different surgical approaches to increase peri-implant mucosal thickness: A randomized controlled clinical trial. J Periodontol. 2018 Jul;89(7):807-814. doi: 10.1002/JPER.17-0597. Epub 2018 Jul 20.
- Natto ZS, Parashis A, Steffensen B, Ganguly R, Finkelman MD, Jeong YN. Efficacy of collagen matrix seal and collagen sponge on ridge preservation in combination with bone allograft: A randomized controlled clinical trial. J Clin Periodontol. 2017 Jun;44(6):649-659. doi: 10.1111/jcpe.12722. Epub 2017 May 26.
- Tonetti MS, Sanz M, Avila-Ortiz G, Berglundh T, Cairo F, Derks J, Figuero E, Graziani F, Guerra F, Heitz-Mayfield L, Jung RE, Lai H, Needleman I, Papapanou PN, Sailer I, Sanz-Sanchez I, Schwarz F, Shi J, Thoma D. Relevant domains, core outcome sets and measurements for implant dentistry clinical trials: The Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus report. J Clin Periodontol. 2023 May;50 Suppl 25:5-21. doi: 10.1111/jcpe.13808. Epub 2023 May 4.
- Vignoletti F, Matesanz P, Rodrigo D, Figuero E, Martin C, Sanz M. Surgical protocols for ridge preservation after tooth extraction. A systematic review. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:22-38. doi: 10.1111/j.1600-0501.2011.02331.x.
- Barone A, Toti P, Quaranta A, Alfonsi F, Cucchi A, Calvo-Guirado JL, Negri B, Di Felice R, Covani U. Volumetric analysis of remodelling pattern after ridge preservation comparing use of two types of xenografts. A multicentre randomized clinical trial. Clin Oral Implants Res. 2016 Nov;27(11):e105-e115. doi: 10.1111/clr.12572. Epub 2015 Feb 26.
- Avila-Ortiz G, Couso-Queiruga E, Stuhr S, Chambrone L. Long-term outcomes of post-extraction alveolar ridge preservation and alveolar ridge reconstruction followed by delayed implant placement: A systematic review. Periodontol 2000. 2025 Jul 3. doi: 10.1111/prd.12642. Online ahead of print.
- Araujo MG, Dias DR, Matarazzo F. Anatomical characteristics of the alveolar process and basal bone that have an effect on socket healing. Periodontol 2000. 2023 Oct;93(1):277-288. doi: 10.1111/prd.12506. Epub 2023 Aug 2.
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)
2026年5月26日
一次修了 (推定)
2027年10月31日
研究の完了 (推定)
2027年10月31日
試験登録日
最初に提出
2026年4月10日
QC基準を満たした最初の提出物
2026年5月6日
最初の投稿 (実際)
2026年5月12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6月2日
最終確認日
2026年6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
- STUDY25080006
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 outside the primary research group due to concerns regarding participant privacy and confidentiality, as approved by the University of Pittsburgh Institutional Review Board.
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
はい
米国で製造され、米国から輸出された製品。
いいえ
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