Application of Alloplastic Bone Graft With Polycaprolactone (PCL) Membrane and ECM-Collagen Membrane on Secondary Socket Healing in Third Molar Surgery. (PCL ECM)
A Comparative Study on the Application of Alloplastic Bone Graft With Polycaprolactone (PCL) Membrane and ECM-Collagen Membrane on Secondary Socket Healing in Third Molar Surgery.
This study compared two membrane materials: 1. polycaprolactone (PCL) and 2. Extracellular matrix collagen membrane (ECM) as alternative. This is to see how well they prevent bone and gum damage after lower wisdom tooth removal. In this split-mouth trial, participants had both lower wisdom teeth removed, with one socket receiving PCL membrane and the other receiving ECM membrane after socket filled with EthOss (an alloplastic bone graft). Over a 24-week follow-up period, researchers tracked patient clinically on their comfort, gum healing, and new bone growth using X-rays.
Обзор исследования
Статус
Статус
Условия
Условия
Вмешательство/лечение
Вмешательство/лечение
Подробное описание
Surgical removal of impacted mandibular third molars (M3) often associated with post-operative morbidities such as pain, facial swelling, limited mouth opening and injuries to the inferior alveolar nerve or lingual nerve. In addition, it can result in compromised periodontal health of the adjacent second molar (M2) and reduced alveolar bone height at the M3 region. The defect can be restored using bone substitutes with membrane. This study aims to assess wound healing of the surgical sites of third molar surgery with application of alloplastic bone graft with PCL membrane and ECM-collagen membrane. This is a split-mouth, double blinded, randomized controlled study. Participants underwent surgical removal of bilateral impacted mandibular third molars with either socket covered with PCL membrane and ECM-collagen membrane after filled up EthOss® alloplastic graft. The participants will be reviewed at post-operative 1 week (T1), 1 month (T2), 3 months (T3) and 6 months (T4) to monitor for signs of graft reaction/rejection. Periodontal assessments were performed at these four visits to assess the soft tissue healing. Radiological assessment (intraoral periapical x-ray) will be done at preoperative and post-operative week 24 to assess bone depth.
Тип исследования
Тип исследования
Регистрация (Оцененный)
Регистрация
Фаза
Фаза
- Фаза 4
Контакты и местонахождение
Места учебы
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Kuala Lumpur, Малайзия, 50603
- Faculty of Dentistry, Universiti Malaya
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Критерии участия
Критерии приемлемости
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
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Patient who requires surgical removal of bilateral impacted M3.
- Patient with impacted bilateral M3 which are sound.
- Impacted bilateral M3 classified as Class I or II with Level A or B according to Pell and Gregory's classification.
- Presence of disease-free mandibular second molar (M2) adjacent to the M3 to be extracted
- Patient aged 18 to 35 years old who are medically fit
Exclusion Criteria:
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Impacted M3 associated with:
- Fracture of angle of mandible.
- Radiological evidence of cyst or tumour.
- Incomplete root formation.
- Acute pulpitis or severe pericoronitis that is not under controlled.
- Gross dental caries.
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Retained roots of mandibular third molar with history of removal or coronectomy of unerupted/impacted M3.
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Patients with periodontal disease
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Patients with absence of lower second molars.
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Medically compromised patients
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Pregnant women.
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Patient on oral contraceptives.
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Current or previous bisphosphonate therapy or history of radiotherapy to the jaws.
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Active smokers
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Одногрупповое задание
- Маскировка: Тройной
Количество рук
Оружие и интервенции
Группа участников / АрмияГруппа участников / Армия |
Вмешательство/лечениеВмешательство/лечение |
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Активный компаратор: PCL membrane
This is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. PCL membrane and Intervention 2. ECM collagen membrane after socket filled with Ethoss alloplast material simultaneously on either sides of the lower third molar |
This is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. PCL membrane and Intervention 2.ECM collagen membrane simultaneously on opposite sides of the lower third molar after socket filled up with alloplast.
Другие имена:
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Активный компаратор: ECM collagen membrane
This is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. PCL membrane and Intervention 2. ECM collagen membrane after socket filled with Ethoss alloplast material simultaneously on either sides of the lower third molar |
This is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. PCL membrane and Intervention 2.ECM collagen membrane simultaneously on opposite sides of the lower third molar after socket filled up with alloplast. |
Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Periodontal health assessment on lower second molar (1)
Временное ограничение: baseline on day of surgery, 12 weeks and 24 weeks after surgery
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1. Modified Plaque Score (from Score 0: No plaque present. Score 1: No visible plaque, but a periodontal probe skimmed across the tooth surface reveals soft plaque biofilm on the tip. Score 2: Visible plaque that can be easily seen with the naked eye without using a probe., modified bleeding score and gingival recession, periodontal pocketing depth)-- the lower the score, the better the periodontal health. |
baseline on day of surgery, 12 weeks and 24 weeks after surgery
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Periodontal health assessment on lower second molar (2)
Временное ограничение: baseline on day of surgery, 12 weeks and 24 weeks after surgery
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Modified Bleeding Score (Score 0: No bleeding observed after probing. Score 1: Bleeding is present.)-- the lower the score, the better the periodontal health |
baseline on day of surgery, 12 weeks and 24 weeks after surgery
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Periodontal health assessment on lower second molar (3)
Временное ограничение: baseline on day of surgery, 12 weeks and 24 weeks after surgery
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Periodontal Pocketing Depth (PPD) (measurement in milimeter, 1-3mm indicate healthy sulcus while >5mm indicate periodontal disesase)-- the lower the score, the better the periodontal health. |
baseline on day of surgery, 12 weeks and 24 weeks after surgery
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Periodontal health assessment on lower second molar (4)
Временное ограничение: baseline on day of surgery, 12 weeks and 24 weeks after surgery
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Gingival Recession- measurement in mm for gingival margin below the cementoenamel junction. - the lower the score, the better the periodontal health. |
baseline on day of surgery, 12 weeks and 24 weeks after surgery
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Periodontal health assessment on lower second molar (5)
Временное ограничение: baseline on day of surgery, 12 weeks and 24 weeks after surgery
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The healing index of Landry (Grade 1 poor to Grade 5 excellent) |
baseline on day of surgery, 12 weeks and 24 weeks after surgery
|
Вторичные показатели результатов
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The width of keratinized tissue
Временное ограничение: baseline on day of surgery, 12 weeks and 24 weeks after surgery
|
The width of the keratinized gingiva will also be measured buccolingual at 6mm distal to the M2. |
baseline on day of surgery, 12 weeks and 24 weeks after surgery
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Bone gain at distal of lower second molar
Временное ограничение: radiograph taken prior to surgery and 24 weeks after surgery
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The radiographic bone level will be measured at T0 and T4 as the distance between the distal point of a line passing through the cemento-enamel junction of M2 (mesial and distal projection of M2's CEJ) and the bone peak distal to M2, at the bottom of the bony defect Measurement in milimeter. |
radiograph taken prior to surgery and 24 weeks after surgery
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Соавторы и исследователи
Спонсор
Спонсор
Соавторы
Соавторы
Следователи
Следователи
- Директор по исследованиям: Wei Cheong Ngeow, PhD, Department of Oral and Maxillofacial Clinical Sciences, Faculty of Dentistry, Universiti Malaya, Malaysia
- Главный следователь: Rou Enn Ng, BDS, Department of Oral and Maxillofacial Clinical Sciences, Faculty of Dentistry, Universiti Malaya, Malaysia
Публикации и полезные ссылки
Общие публикации
- Aimetti, M., Romano, F., Pigella, E., Pranzini, F., & Debernaerdi, C. (2005). Treatment of Wide, Shallow, and Predominantly 1-Wall Intrabony Defects With a Bioabsorbable Membrane: A Randomized Controlled Clinical Trial. Journal of Periodontology, 76(8), 1354-1361. Bohner, M., Santoni, B. L. G., & Dobelin, N. (2020). Beta-tricalcium phosphate for bone substitution: Synthesis and properties. Acta Biomater, 113, 23-41. Canullo, L., Rossi-Fedele, G., Camodeca, F., Menini, M., & Pesce, P. (2021). A Pilot Retrospective Study on the Effect of Bone Grafting after Wisdom Teeth Extraction. Materials (Basel), 14(11https://doi.org/10.3390/ma14112844). Chen, G., Sato, T., Ohgushi, H., Ushida, T., Tateishi, T., & Tanaka, J. (2005). Culturing of skin fibroblasts in a thin PLGA-collagen hybrid mesh. Biomaterials, 26(15), 2559-2566. De Angelis, N., Pesce, P., Poedjiastoeti, W., Suwandi, T., Tjandrawinata, R., Bagnasco, F., & Menini, M. (2024). 3D-Printable Biopolymers for Socket Preservation Technique: Soft Tissues Response: A Pilot Randomised Clinical Study. Dent J (Basel), 12(10). Retrieved Oct 7, from https://www.ncbi.nlm.nih.gov/pubmed/39452449 Dodson, T. B. (2004). Management of Mandibular Third Molar Extraction Sites to Prevent Periodontal Defects. Journal of Oral and Maxillofacial Surgery, 62(10), 1213-1224. Fairbairn, P., Kilner, S., O'Hooley, D., Fish, A., & Kurtzman, G. M. (2023). Sinus Augmentation for Implant Placement Utilizing a Novel Synthetic Graft Material with Delayed Immediate Socket Grafting: A 2-Year Case Study. J. Clin. Med, 12(1). Goh, B. T., Teh, L. Y., Tan, D. B., Zhang, Z., & Teoh, S. H. (2015). Novel 3D polycaprolactone scaffold for ridge preservation--a pilot randomised controlled clinical trial. Clin Oral Implants Res, 26(3), 271-277. Retrieved Mar, from https://www.ncbi.nlm.nih.gov/pubmed/25263527 Jambhekar, S., Kernen, F., & Bidra, A. S. (2015). Clinical and histologic outcomes of socket grafting after flapless tooth extraction:
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Начало исследования
Первичное завершение (Оцененный)
Первичное завершение
Завершение исследования (Оцененный)
Завершение исследования
Даты регистрации исследования
Первый отправленный
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Первый опубликованный
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее опубликованное обновление
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- DF OS 2512/0060 (P)
- UMG057E-2025 (Другой номер гранта/финансирования: Universiti Internal Grant (DPRG))
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Individual participant data (IPD) will not be shared to protect participant confidentiality and privacy. The informed consent approved by the Ethics Committee/Institutional Review Board (IRB) did not include explicit authorization from participants for secondary data sharing or broad external repository deposition. Furthermore, due to the granular nature of the clinical data collected, full de-identification cannot be guaranteed without risk of re-identification. Aggregate data, summary statistics, and primary outcomes will instead be made available through peer-reviewed publications.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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. .