- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07589751
Biomaterials Exposed to Oral Environment: Which One is the Appropriate Option?
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
- Ethical considerations and patient selection This study will be previously submitted to the ethical committee of PUCRS - Brazil for appreciation and evaluation following the international ethical guidelines for clinical studies. Following ethical acceptance, patients needing non-molar tooth extraction with four/three walls of alveolar integrity will be selected for this study. Exclusion and inclusion criteria will be applied in the patient's selection according to potential systemic diseases and external habits that influence bone regeneration. (please, check inclusion and exclusion criteria).
Surgical procedures and group division Following patient selection, minimal invasive extractions will be performed and standard alveolar preservation will be done using Bio-oss Collagen® - Geistlich for alveolar filling and (BioGide® or Mucograft® Seal - Geistlich, depending on the study group) for covering the gap-filling procedure showing one biomaterial side exposed to the oral cavity environment. The patients will be divided randomly into three experimental groups of 20 patients each, completing 60 patients. One group will receive alveolar preservation with Bio-oss Collagen® + BioGide® and the other group will receive alveolar preservation with Bio-oss Collagen® + Mucograft® Seal. A negative control group will be applied without any type of alveolar preservation, only minimally invasive extraction.
Evaluation time points will be named T0, T1, T2, T3 (T0 = immediate after surgery, T1 = 1 week, T2 = 3 weeks, T3 = 3 months).
After surgeries, patients will receive detailed verbal and written post-operative instructions, prescriptions for anti-inflammatory medication (ibuprofen 600 mg for 3 days, if needed), and antibiotic therapy (amoxicillin 500 mg every 8h for 7 days or, in case of penicillin allergy, clindamycin 300 mg every 6h for 7 days). Patients will be recalled at 1 (T1), 3 weeks (T2), and after three months (T3). Sutures were removed at 1 week. Patients will be advised to not use mouth rinses in order to not compromise the surgical procedure. Normal hygiene using toothbrushes and toothpastes will be indicated to the patients to maintain clean conditions.
Following surgical procedures, the surgical sites will be evaluated regarding biomaterial contamination, clinical tissue healing, and radiographic conditions.
Biomaterial surface contamination For biomaterial contamination, a sterilized swab for bacterial analysis will be used directly over the procedure (per patient/per time) for investigation of potential biomaterial surface contamination at T0, T1, and T2. Following this, the bacterial collection will be processed and evaluated at the Microbiological laboratory. The potential bacterial collection will be spread in agar plates and cultured in a stove under appropriate bacteria conditions for 24 hours. Bacteria colonies will be evaluated and counted comparing the proposed groups and time points in this study.
A control collection will be performed before the surgical procedure in the tooth extraction region using a sterilized swab to evaluate the previous microbiome and similarities to the post-surgery evaluations.
- Radiographic evaluation For radiographic investigation, digital periapical radiographs will be performed on pre-operatory days (for diagnostics of tooth extraction); at T1 and T3, evaluating potential procedure failures or infiltration by comparing the time points. Measurements will be performed digitally using the radiographic software associated with the X-ray to investigate regenerated bone and possible bacterial infiltration comparing the groups.
- Qualitative and quantitative clinical outcomes Early clinical healing will be evaluated at three different times (T0, T1, T2, T3) through clinical observation and alveolar measurements using a periodontal probe in millimeters. Linear alveolar size and soft tissue contour measurements will be evaluated using a periodontal probe (measuring the mesio-distal and buccal-lingual/palatal distance in millimeters) according to the alveolo size and possible alveolo changes, directly after tooth extraction, at T0, T1, T2, and T3. Additionally, qualitative photographs will be performed for evaluation of early tissue healing, possible infection, possible failures, and/or dehiscence.
- Patient-reported outcome measures Patients will be asked to rate their level of post-operative discomfort and overall satisfaction after alveolar ridge preservation at T0, T1, T2 and T3. The questionnaire will be applied using a simple table with a 100-point visual analogue scale where the patient will be able to select from 0 to 100 (0 for worst evaluation and 100 for the higher evaluation). (Couso-Queiruga et al. Influence of healing time on the outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: a randomized clinical trial. Journal of clinical periodontology, 50(2), 132-146, 2023).
- Statistical analysis The data will be analyzed using one-way ANOVA, followed by post hoc testing Tukey HSD test if necessary, comparing the three experimental groups in the three different time points. Bacterial assays will be performed in triplicate for each time point. A significant variation between groups was considered to occur at 5% (p < 0.05).
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Бразилия, 90619900
- PUCRS
-
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
Adult subjects in need of non-molar maxillary or mandibular single tooth extraction at the PUCRS university - Porto Alegre - Brazil.
- > 18 years of age
- non-molar tooth indicated for extraction
- intact sockets upon extractions
- Patients using removable provisional prosthesis (accessible to remove possible contact with surgical site) or patients without prosthesis after tooth extraction.
Exclusion Criteria:
- Current smokers
- Uncontrolled Diabetes Mellitus
- Mandibular incisors
- Patients receiving chemo or radiotherapy or history of these treatments in the previous 5 years
- Any other disease or medications that may compromise normal wound healing
- Unwilling or unable to sing the informed consent
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: Negative control group
A negative control group will be applied without any type of alveolar preservation, only minimally invasive extraction.
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|
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Экспериментальный: Group test 1
Alveolar ridge preservation (ARP) using Bio-Oss Collagen® + Bio-Gide® exposed to the oral environment.
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Alveolar ridge preservation (ARP) using Bio-Oss Collagen® + Bio-Gide® exposed to the oral environment.
ARP using Bio-Oss Collagen® + Mucograft® Seal® exposed to the oral environment.
|
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Экспериментальный: Group test 2
Alveolar ridge preservation using Bio-Oss Collagen® + Mucograft® Seal® exposed to the oral environment.
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Alveolar ridge preservation (ARP) using Bio-Oss Collagen® + Bio-Gide® exposed to the oral environment.
ARP using Bio-Oss Collagen® + Mucograft® Seal® exposed to the oral environment.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Alveolar dimension changes (millimetres)
Временное ограничение: From the surgery to the last follow-up at 3 months
|
To compare the alveolar dimensions (vertically and horizontally) in millimetres of two different approaches using biomaterials (collagen membrane vs.
collagen matrix) when intentionally exposed to the oral environment after an alveolar preservation procedure without primary closure, and a negative control without alveolar preservation.
These measures will be done using periodontal probes by a trained and calibrated evaluator.
|
From the surgery to the last follow-up at 3 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Biomaterial contamination (colony count - bacterial colony number)
Временное ограничение: Immediately after surgery to 21 days of follow-up
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To compare the number of colonies formed after contamination collection with swabs on the surfaces of two different biomaterials (collagen membrane vs collagen matrix) when intentionally exposed to the oral environment following an alveolar preservation procedure without primary closure.
The number of colonies will be counted with a microscope and tabulated in accordance with microbiological standards.
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Immediately after surgery to 21 days of follow-up
|
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Radiographic alveolar bone dimensions (vertical and horizontal measures) in millimetres
Временное ограничение: From the surgery to the last follow-up at 3 months
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A radiographic comparison of the alveolar dimension changes between the three groups will be done using digital periapical radiographs and a digital ruler in the radiographic software to measure the alveolar dimensions (vertically and horizontally) in millimetres after the surgical procedures.
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From the surgery to the last follow-up at 3 months
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Patient-related outcomes (OHIP-49 and VAS questionnaires) - score
Временное ограничение: From the surgery to the last follow-up at 3 months.
|
To investigate the quality of life measurements using the OHIP-49 questionnaire and to measure pain using the VAS scale questionnaire after the surgical interventions.
These questionnaires have a scale pointing 1 to 5, which generates a score for each question.
Therefore, the measure will be a final score at each time point.
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From the surgery to the last follow-up at 3 months.
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Соавторы и исследователи
Соавторы
Публикации и полезные ссылки
Общие публикации
- Couso-Queiruga E, Weber HA, Garaicoa-Pazmino C, Barwacz C, Kalleme M, Galindo-Moreno P, Avila-Ortiz G. Influence of healing time on the outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: A randomized clinical trial. J Clin Periodontol. 2023 Feb;50(2):132-146. doi: 10.1111/jcpe.13744. Epub 2022 Nov 18.
- Barootchi S, Tavelli L, Majzoub J, Stefanini M, Wang HL, Avila-Ortiz G. Alveolar ridge preservation: Complications and cost-effectiveness. Periodontol 2000. 2023 Jun;92(1):235-262. doi: 10.1111/prd.12469. Epub 2022 Dec 29.
- Kunrath MF, Dahlin C. The Impact of Early Saliva Interaction on Dental Implants and Biomaterials for Oral Regeneration: An Overview. Int J Mol Sci. 2022 Feb 11;23(4):2024. doi: 10.3390/ijms23042024.
- Kunrath MF, Giraldo-Osorno PM, Mendes K, Gomes ATPC, Rosa N, Barros M, Dahlin C. Unveiling the consequences of early human saliva contamination on membranes for guided bone regeneration. J Periodontal Res. 2024 Dec;59(6):1196-1209. doi: 10.1111/jre.13266. Epub 2024 Apr 22.
- Buser D, Urban I, Monje A, Kunrath MF, Dahlin C. Guided bone regeneration in implant dentistry: Basic principle, progress over 35 years, and recent research activities. Periodontol 2000. 2023 Oct;93(1):9-25. doi: 10.1111/prd.12539.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- CAAE 92555525.3.0000.5336
- MTA 24-209 (Другой номер гранта/финансирования: Geistlich Pharma AG)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Совместное использование IPD Поддерживающий тип информации
- САП
- МКФ
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. .
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