Surgical Treatment of Peri-implantitis Defects
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Test group 1 (T1), Test group 2 (T2), Control group (C).
- Кому может быть актуально
- Состояния в реестре: Peri Implantitis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Efficacy of Electrolysis Decontamination with or Without Leukocyteplatelet Rich Fibrin (L-PRF) in the Surgical Treatment of Peri-implantitis Defects: a Randomized Controlled Trial
Обзор
The aim of this study is to evaluate the efficacy of implant surface decontamination using electrolysis cleaning system. And to evaluate the adjunctive use of L-PRF in promoting soft tissue healing and long-term stability of the peri-implant marginal bone in the surgical treatment of peri-implantitis.
Подробное описание
Research design
* Prospective, in which participants will be recruited and then followed up throughout a specified period of time. * Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either control or test groups. * Single-blinded as the outcome accessors will be blinded to the intervention.
Materials and Methods:
Patients attending Dubai Dental Hospital and requiring treatment of peri-implantitis will be invited to take part in this randomized controlled trial based on the following inclusion and exclusion criteria:
Inclusion criteria:
* Aged 18 or over. * Require treatment of peri-implantitis (defined as the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥ 6 mm, presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling). * Screw retained implant crown. * Good compliance and commitment to attend follow-up review appointments. * Willing to provide informed consent.
Exclusion criteria
* History of surgical therapy of peri-implantitis. * Peri-implant defects indicated for regenerative procedure (i.e. contained bony defect). * Cement retained implant crown. * Systemic/local antibiotics during the previous 6 months. * Bone metabolic disease and/or taking medications that affect bone metabolism. * History of malignancy, radiotherapy or chemotherapy. * Pregnant or lactating women. * Smokers
The study will be conducted following the ethical standards of the Declaration of Helsinki in 1975, as revised in 2013 and the CONSORT statement will be used as a guideline in reporting this study.
Randomization, allocation concealment and blinding:
The participants will be randomly allocated to three equally sized groups using computer-generated numbers:
Control group (C): Conventional open flap debridement Test group 1 (T1): Open flap debridement using (GalvoSurge® - Straumann) Test group 2 (T2): Open flap debridement using (GalvoSurge® - Straumann) combined with L-PRF application
Вмешательства
- Процедура Test group 1 (T1)
Test group 1 (T1): Open flap debridement using electrolysis decontamination - Процедура Test group 2 (T2)
Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF application - Процедура Control group (C)
Conventional open flap debridement
Первичные конечные точки
- Probing pocket depth [Срок оценки: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months]
Вторичные конечные точки (4)
- Presence or absence of plaque, bleeding on probing and suppuration [Срок оценки: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months]
- Peri-implant marginal bone level [Срок оценки: Baseline (prior to surgical intervention), 12 and 24 months]
- Peri-implant soft tissue level [Срок оценки: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months]
- Peri-implant soft tissue thickness (Phenotype) [Срок оценки: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months]
Критерии участия
Критерии включения
- Aged 18 or over.
- Require treatment of peri-implantitis (defined as the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥ 6 mm, presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling).
- Screw retained implant crown.
- Good compliance and commitment to attend follow-up review appointments.
- Willing to provide informed consent.
Критерии исключения
- History of surgical therapy of peri-implantitis.
- Peri-implant defects indicated for regenerative procedure (i.e. contained bony defect).
- Cement retained implant crown.
- Systemic/local antibiotics during the previous 6 months.
- Bone metabolic disease and/or taking medications that affect bone metabolism.
- History of malignancy, radiotherapy or chemotherapy.
- Pregnant or lactating women.
- Smokers
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
Список центров уточняется — проверьте первичный протокол.
Публикации
- Hamzacebi B, Oduncuoglu B, Alaaddinoglu EE. Treatment of Peri-implant Bone Defects with Platelet-Rich Fibrin. Int J Periodontics Restorative Dent. 2015 May-Jun;35(3):415-22. doi: 10.11607/prd.1861. PMID 25909530
Идентификаторы
NCT: NCT06614426 · MBRU IRB-2024-563