- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07610876
Autologous Demineralized Dentin Graft With or Without Melatonin for Immediate Implant Osseointegration
Effect of Autologous Demineralized Dentin Graft With or Without Melatonin Gel on the Osseo Integration of Immediately Placed Implants: A Randomized Clinical Study
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Patients requiring extraction and immediate implant placement in the maxillary premolar region often present with peri-implant defects and jumping gaps that may compromise osseointegration and long-term implant success. Autogenous bone grafts are considered the gold standard for bone augmentation because of their osteogenic, osteoinductive, and osteoconductive properties; however, they are associated with donor-site morbidity, limited availability, and increased surgical time. Recently, autologous demineralized dentin graft (ADDG) derived from extracted teeth has been introduced as a promising alternative grafting material due to its chemical and histological similarity to alveolar bone.
Dentin and bone share a common embryologic origin and similar composition, including type I collagen and low crystalline hydroxyapatite. Demineralized dentin graft material has demonstrated favorable osteoconductive and osteoinductive properties and has been successfully used in guided bone regeneration and immediate implant procedures. In immediate implant placement, the extracted tooth may be processed and reused as graft material to fill the jumping gap around the implant.
Melatonin (N-acetyl-5-methoxytryptamine) is an antioxidant molecule that has demonstrated beneficial effects on bone metabolism and osseointegration. Melatonin reduces osteoclastic activity, promotes osteoblast differentiation, enhances bone formation, and decreases oxidative stress during healing. Previous studies have suggested that local application of melatonin around dental implants may improve early osseointegration and bone healing.
The purpose of this randomized clinical study is to evaluate clinically and radiographically the effect of using melatonin gel in conjunction with autologous demineralized dentin graft on the osseointegration of immediately placed implants.
Sixteen patients with non-restorable maxillary premolar teeth indicated for extraction and immediate implant placement will be recruited from the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University. Eligible patients will be randomly allocated into two equal groups. In Group I, immediate implants will be placed and the jumping gap will be filled using autologous demineralized dentin graft alone. In Group II, immediate implants will be placed and the jumping gap will be filled using autologous demineralized dentin graft mixed with melatonin gel.
Clinical assessment will include implant stability measurement using the Penguin device, peri-implant sulcus depth, and modified bleeding on probing index. Radiographic evaluation will be performed using cone beam computed tomography (CBCT) to assess marginal bone loss, buccal bone thickness, buccal bone height, jumping distance, and bone density at baseline, immediately after implant placement, and during follow-up periods up to 9 months postoperatively.
The results of this study may help determine whether the addition of melatonin gel to autologous demineralized dentin graft improves osseointegration and peri-implant bone healing in immediate implant placement procedures.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: B.S.D Abd El Fattah ELSaid Attia
- Номер телефона: +20100465932
- Электронная почта: PGS.230043@dent.suez.edu.eg
Места учебы
-
-
-
Ismailia, Египет
- Рекрутинг
- Suez Canal University, Faculty of Dentistry
-
Контакт:
- Dean, Faculty of Dentistry, Suez Canal University
- Номер телефона: (+2064) 3223007
- Электронная почта: President_office@suez.edu.eg
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Age above 20 years
- Non-restorable maxillary premolar teeth
- Candidates for immediate implant placement
- Intact socket walls
- Jumping gap >2 mm
- Non-smokers or light smokers
- No acute infection
- Adequate bone for primary stability
Exclusion Criteria:
- Heavy smokers
- Bruxism or clenching
- Uncontrolled systemic disease
- Chemotherapy/radiotherapy
- Immunocompromised patients
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: ADDG Alone
Participants in this arm will receive immediate implant placement in the maxillary premolar region with jumping gap filling using autologous demineralized dentin graft (ADDG) alone after extraction of non-restorable teeth.
Clinical and radiographic evaluation will be performed during the follow-up period.
|
Autologous demineralized dentin graft prepared from extracted non-restorable teeth will be used for filling the jumping gap around immediately placed dental implants.
Tooth preparation includes removal of restorations, caries, periodontal ligament, pulp tissue, calculus, and cementum, followed by grinding and demineralization using 2% nitric acid before graft placement.
|
|
Экспериментальный: ADDG + Melatonin Gel
Participants in this arm will receive immediate implant placement in the maxillary premolar region with jumping gap filling using autologous demineralized dentin graft (ADDG) mixed with melatonin gel after extraction of non-restorable teeth.
Clinical and radiographic evaluation will be performed during the follow-up period.
|
Melatonin gel will be mixed with autologous demineralized dentin graft and used for filling the jumping gap around immediately placed dental implants in the maxillary premolar region to enhance osseointegration and peri-implant bone healing.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Implant Stability Quotient (ISQ)
Временное ограничение: Baseline and 6 months
|
Measured using Penguin device immediately after implant placement and after 6 months.
|
Baseline and 6 months
|
|
Jumping Distance
Временное ограничение: Immediate postoperative and 9 months after implant placement
|
The horizontal bucco-implant gap (jumping distance) will be measured radiographically using CBCT at 0 mm, 2 mm, and 5 mm apical to the implant shoulder as the perpendicular distance from the implant surface to the inner buccal bone plate.
|
Immediate postoperative and 9 months after implant placement
|
|
Marginal Bone Loss
Временное ограничение: Immediate postoperative and 9 months after implant placement
|
Marginal bone loss will be assessed radiographically using cone beam computed tomography (CBCT) as the vertical distance from the implant platform to the alveolar crest around the implant.
|
Immediate postoperative and 9 months after implant placement
|
|
Bone Density
Временное ограничение: Immediate postoperative and 9 months after implant placement
|
Bone density around the implant will be measured radiographically using CBCT and expressed in Hounsfield units (HU) to evaluate peri-implant bone maturation and osseointegration.
|
Immediate postoperative and 9 months after implant placement
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Buccal Bone Thickness (BBT)
Временное ограничение: Preoperative, immediate postoperative, and 9 months after implant placement
|
Buccal bone thickness will be measured radiographically using standardized CBCT scans at 0 mm, 2 mm, and 5 mm apical to the implant shoulder to evaluate horizontal buccal bone dimensional changes around immediately placed implants.
|
Preoperative, immediate postoperative, and 9 months after implant placement
|
|
Buccal Bone Height (BBH)
Временное ограничение: Preoperative, immediate postoperative, and 9 months after implant placement
|
Buccal bone height will be assessed radiographically using CBCT as the vertical distance from the implant shoulder to the most coronal buccal bone point.
|
Preoperative, immediate postoperative, and 9 months after implant placement
|
|
Peri-Implant Sulcus Depth (PISD)
Временное ограничение: Baseline, 6 months, and 9 months
|
Peri-implant sulcus depth will be measured clinically using a periodontal probe at the buccal, palatal, mesial, and distal aspects around the implant.
|
Baseline, 6 months, and 9 months
|
|
Modified Bleeding on Probing Index (MBOP)
Временное ограничение: Baseline, 6 months, and 9 months
|
Modified bleeding on probing index will be recorded clinically using a periodontal probe to evaluate peri-implant soft tissue inflammation around the implant.
|
Baseline, 6 months, and 9 months
|
Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: Hany Kamel Shalaby, Professor of Oral Medicine and Periodontology, Dean Faculty of Dentistry
- Директор по исследованиям: Shaima Mohammed Morsy, Assistant Professor of Oral Medicine and Periodontology
- Директор по исследованиям: Rasha El-Sayed Afifi, Lecturer of Oral Medicine and Periodontology
- Главный следователь: Abd El Fattah ELSaid Attia, B.S.D, B.S.D
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
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
- 854/2024
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
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.
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. .