- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07828431
Comparison of Bond Failure Rate of Orthodontic Brackets Bonded With V-Prep and Resin-Modified Glass Ionomer Cement Versus Conventional Acid-Etch Composite Resin
Comparison of Bond Failure Rate of Orthodontic Brackets Bonded With V-Prep and Resin-Modified Glass Ionomer Cement Versus Conventional Acid-Etch Composite Resin: A Split-Mouth Randomized Controlled Trial
Ethical approval will be obtained by the FUSH and informed consent will be obtained from individual patients/guardians in writing. Inclusion and exclusion criteria will be used to obtain random patient samples within the Orthodontic Department of FUCD&H and Baseline parameters like age, gender, O'Leary Plaque Score, malocclusion classification type and degree of overbite will be recorded. Patients will be screened one at a time if they are eligible. For this purpose, sequentially numbered, opaque sealed envelopes will be opened just before the bonding assignment for allocation concealment. Both orally and in writing to all patients. Tooth surfaces will be pumiced and standardized.
While, the Primer light-cured for 10-sec each item, the Control group (enamel) etched for 30-sec, washed for 15-sec and air dried to a frosty white. The tough brackets will be attached, with a baseline underneath, with a thin layer of composite resin pressed down on optimum. Light cured for 10 seconds on mesial and distal surfaces to remove excess adhesive (STEP 7).
Group II (V-Prep): Enamel surface was were in contact with 0%-1.5% diluted Sodium Hypochlorite during 60 seconds, rinsed and thoroughly dried; then the V-Prep was applied. 37% phosphoric acid gel for 30 Sec, rinsed for 15 Sec and dried until a frost white appearance on the etched enamel area. The first is called Primer and will be light cured for 10 seconds. A template will then be provisionally fixed to secure the bottom of the bracket in place with Resin-Modified Glass Ionomer Cement. Clean of excess adhesive, and cure for 10 seconds mesial and distal.
Then instead of going to bonding, this will be taken out and ligated to a 0.012-in Ni-Ti archwire. Will follow a 30 days interval series of 6 follow-up visits, monthly visits throughout 6 months
Обзор исследования
Статус
Подробное описание
Ethical approval will be obtained by the FUSH and informed consent will be obtained from individual patients/guardians in writing. Inclusion and exclusion criteria will be used to obtain random patient samples within the Orthodontic Department of FUCD&H and Baseline parameters like age, gender, O'Leary Plaque Score, malocclusion classification type and degree of overbite will be recorded. Patients will be screened one at a time if they are eligible. For this purpose, sequentially numbered, opaque sealed envelopes will be opened just before the bonding assignment for allocation concealment. Both orally and in writing to all patients. Tooth surfaces will be pumiced and standardized. To minimize inter-operator variability for any of the procedures listed above, all bonding will be completed by a single operator (principal investigator) that has been trained on the trial.
While, the Primer light-cured for 10-sec each item, the Control group (enamel) etched for 30-sec, washed for 15-sec and air dried to a frosty white. The tough brackets will be attached, with a baseline underneath, with a thin layer of composite resin pressed down on optimum. Light cured for 10 seconds on mesial and distal surfaces to remove excess adhesive (STEP 7).
Group II (V-Prep): Enamel surface was were in contact with 0%-1.5% diluted Sodium Hypochlorite during 60 seconds, rinsed and thoroughly dried; then the V-Prep was applied. 37% phosphoric acid gel for 30 Sec, rinsed for 15 Sec and dried until a frost white appearance on the etched enamel area. The first is called Primer and will be light cured for 10 seconds. A template will then be provisionally fixed to secure the bottom of the bracket in place with Resin-Modified Glass Ionomer Cement. Clean of excess adhesive, and cure for 10 seconds mesial and distal Then instead of going to bonding, this will be taken out and ligated to a 0.012-in Ni-Ti archwire. Will follow a 30 days interval series of 6 follow-up visits, monthly visits throughout 6 months
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Punjab Province
-
Rawalpindi, Punjab Province, Пакистан, 44000
- Foundation University College of Dentistry and Hospital
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Patients aged 12-18 years
- The extraction was limited to Two arches.
- Functional Overbite/Underbite ( < 50% or 1, 2-3 mm?)
- Malocclusions Class I or II
Exclusion Criteria:
- Class III malocclusion
- Type 2: Facial Osteopathy (Cleft lip or palate)
- The history of allergic reactions to dental materials goes back to 1903.Allergic reactions to dental materials date back to 1903.
- Developmental enamel defects (fluorosis, hypoplasia)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Одногрупповое задание
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: V-Prep and Resin-Modified Glass Ionomer Cement
V prep with sodium hypochlorite and bonding with RMGIC
|
V-Prep with sodium hypochlorite and bonding with Resin-Modified Glass Ionomer Cement
|
|
Активный компаратор: Conventional Acid-Etch Composite Resin
Conventional Composite Resin Bonding
|
Conventional Composite Resin bonding
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Bond Failure Rate of Orthodontic Brackets
Временное ограничение: 6 months
|
Time-to-failure of orthodontic brackets between the V-Prep and Resin-Modified Glass Ionomer Cement [RMGIC] and conventional 37% phosphoric acid-etch composite resin technique.
|
6 months
|
Соавторы и исследователи
Спонсор
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
- FUCD-Ortho- 26
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана 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.
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