Effect of Collagen Membrane on Ridge Preservation

Официальное название

Effect of Collagen Membrane on Ridge Preservation for Delayed Implant Placement in Sites With Absent Buccal Bone Wall: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Minimally Invasive tooth extraction
  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.
• Устройство Alveolar ridge preservation with ABCC
  The extraction socket will be grafted with ABCC (SigmaGraft®).
• Устройство Resorbable collagen membrane (InterCollagen® Guide)
  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.

Первичные конечные точки

• Horizontal dimensional changes (%) [Срок оценки: Baseline and 4 months]

Вторичные конечные точки (12)

• Horizontal dimensional changes (%) [Срок оценки: Baseline and 4 months]
• Horizontal dimensional changes (%) [Срок оценки: Baseline and 4 months]
• Vertical dimensional changes (%) [Срок оценки: Baseline and 4 months]
• Vertical dimensional changes (%) [Срок оценки: Baseline and 4 months]
• Volumetric dimensional changes (%) [Срок оценки: Baseline and 4 months]
• Mid-buccal soft tissue contour change (mm) [Срок оценки: Baseline and 4 months]
• Mid-buccal soft tissue volume change (%) [Срок оценки: Baseline and 4 months]
• Interproximal papilla height change (mm) [Срок оценки: Baseline and 4 months]
• Wound healing (Wound Healing Index) [Срок оценки: 1 week, 2 weeks, 1 month, 4 months]
• Incidence of postoperative complications (Percentage) [Срок оценки: 1 week, 2 weeks, 1 month, 4 months]
• Postoperative pain [Срок оценки: Day 1, Day 3, 1 week]
• Oral health-related quality of life (OHIP-14) [Срок оценки: Baseline, 2 weeks, 4 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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);

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Pittsburgh School of Dental Medicine, Department of Periodontics and Prevent — Pittsburgh

Публикации

• 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. PMID 29633268
• 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. PMID 28303642
• 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 PMID 37143289
• 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. PMID 27310522
• 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. PMID 22211304
• 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. PMID 25727443
• 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. PMID 40605823
• 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. PMID 37533162

Идентификаторы

NCT: NCT07580495 · STUDY25080006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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