Effect of Collagen Membrane on Ridge Preservation
2 июня 2026 г. обновлено: 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.
Обзор исследования
Статус
Рекрутинг
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
30
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Carla Sanchez, MS
- Номер телефона: 4126241179
- Электронная почта: cab28@pitt.edu
Учебное резервное копирование контактов
- Имя: Debora R Dias, DDS, PhD
- Номер телефона: 4126488595
- Электронная почта: deboradias@pitt.edu
Места учебы
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Pennsylvania
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Pittsburgh, Pennsylvania, Соединенные Штаты, 15213
- Рекрутинг
- University of Pittsburgh School of Dental Medicine, Department of Periodontics and Preventive Dentistry
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Контакт:
- Andrea Ravida, DDS, PhD
- Номер телефона: 7347309678
- Электронная почта: andrearavida@pitt.edu
-
Главный следователь:
- Debora R Dias, DDS, PhD
-
Контакт:
- Debora R Dias, DDS, PhD
- Номер телефона: 412-648-8595
- Электронная почта: deboradias@pitt.edu
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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);
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: 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.
|
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®).
|
|
Экспериментальный: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Horizontal dimensional changes (%)
Временное ограничение: Baseline and 4 months
|
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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Horizontal dimensional changes (%)
Временное ограничение: 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
|
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Horizontal dimensional changes (%)
Временное ограничение: Baseline and 4 months
|
Change in horizontal ridge width at 5 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
|
Baseline and 4 months
|
|
Vertical dimensional changes (%)
Временное ограничение: Baseline and 4 months
|
Change in vertical ridge height at the midbuccal aspect, measured on CBCT scans and expressed in percentage change.
|
Baseline and 4 months
|
|
Vertical dimensional changes (%)
Временное ограничение: Baseline and 4 months
|
Change in vertical ridge height at the mid palatal aspect, measured on CBCT scans and expressed in percentage change.
|
Baseline and 4 months
|
|
Volumetric dimensional changes (%)
Временное ограничение: Baseline and 4 months
|
Change in the volume of the alveolar process (mm3), measured on CBCT scans in comparison to baseline and expressed in percentage change.
|
Baseline and 4 months
|
|
Mid-buccal soft tissue contour change (mm)
Временное ограничение: 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 (%)
Временное ограничение: Baseline and 4 months
|
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.
|
Baseline and 4 months
|
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Interproximal papilla height change (mm)
Временное ограничение: Baseline and 4 months
|
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
|
|
Wound healing (Wound Healing Index)
Временное ограничение: 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)
Временное ограничение: 1 week, 2 weeks, 1 month, 4 months
|
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.
|
1 week, 2 weeks, 1 month, 4 months
|
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Postoperative pain
Временное ограничение: Day 1, Day 3, 1 week
|
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)
Временное ограничение: Baseline, 2 weeks, 4 months
|
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
Временное ограничение: 4 months
|
Ability to place the implant in a prosthetically ideal three-dimensional position at reentry without the need for additional hard-tissue augmentation.
|
4 months
|
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Histological Outcomes
Временное ограничение: 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)
Временное ограничение: 4 months
|
Visual analogue scale (0-100) of patient satisfaction with the appearance of the soft tissues
|
4 months
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Следователи
- Главный следователь: Debora R Dias, DDS, PhD, University of Pittsburgh, Department of Periodontics and Preventive Dentistry
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
26 мая 2026 г.
Первичное завершение (Оцененный)
31 октября 2027 г.
Завершение исследования (Оцененный)
31 октября 2027 г.
Даты регистрации исследования
Первый отправленный
10 апреля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
6 мая 2026 г.
Первый опубликованный (Действительный)
12 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
4 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
2 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- STUDY25080006
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Да
продукт, произведенный в США и экспортированный из США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .