Effect of Nano-structured Alumina Coating on the Bond Strength of Zirconia Resin-bonded Fixed Dental Prostheses
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: NAC, APA.
- Кому может быть актуально
- Состояния в реестре: Missing Incisors, Zirconia Surface Pretreatment, Children, Adults. Базовые параметры: Без ограничений · 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
- Словения
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The purpose of this study is to evaluate the clinical outcome of resin-bonded fixed dental prostheses (RBFDPs) pretreated with nanostructured alumina coating (NAC). The study adopts a prospective, randomized, controlled, double-blind design contrasting the use of NAC to air-borne particle abrasion (APA) (control) as a surface pretreatment method of zirconia RBFDPs used for replacing missing central or lateral incisors. The primary outcome evaluated is the retention/survival of the zirconia RBFDPs pretreated with APA and NAC.
Подробное описание
Zirconia resin-bonded fixed dental prostheses (RBFDPs) have been regarded as a promising minimally invasive alternative for the replacement of missing central and lateral incisors, offering several advantages to orthodontic space closure or tooth replacement with implant-supported restorations. Debonding of the zirconia RBFDPs represents the main technical complication since clinically established airborne particle abrasion (APA) of an inert zirconia surface does not always provide sufficient resin-bond strength. Further, APA can also impair the mechanical properties of zirconia restoration affecting its long-term success. Nano-structured alumina coating (NAC) presents an alternative non-invasive zirconia surface pretreatment. The aim of this randomized controlled clinical trial is to study the effect of NAC coated bonding surface of zirconia RBFDPs affecting its debonding and clinical survival rate.
The study adopts a prospective, randomized, controlled, double-blind design contrasting the use of NAC to air-borne particle abrasion (APA) as a surface pretreatment method of zirconia RBFDPs. Healthy patients in need of a missing central or lateral incisor replacement are screened and rated to be eligible by two calibrated dentists. RBFDPs are randomly allocated into two groups and inserted by the same operator. The first group, where the bonding surface is pretreated with APA serves a control group. In the second group the restorations are pretreated with NAC. The participants and the operator are blinded to the group assignment in a double-blinded trial design. The primary outcome evaluated is the retention/survival of the RBFDP. Non-parametric tests and Kaplan-Meyer analysis will be used to determine differences between both study groups.
Вмешательства
- Другое NAC
Pretreatment of zirconia RBFDP with nanostructured alumina coating after milling of RBFDP's framework - Другое APA
Air-borne particle abrasion of zirconia RBFDPs prior to bonding
Первичные конечные точки
- Survival rate of zirconia RBFDPs [Срок оценки: From baseline through study completion, an average of 1 year]
Вторичные конечные точки (6)
- Porcelain chipping [Срок оценки: From baseline through study completion, an average of 1 year]
- Zirconia framework fracture [Срок оценки: From baseline through study completion, an average of 1 year]
- Gingivitis [Срок оценки: From baseline through study completion, an average of 1 year]
- Parodontitis [Срок оценки: From baseline through study completion, an average of 1 year]
- Marginal leakage [Срок оценки: From baseline through study completion, an average of 1 year]
- Secondary caries [Срок оценки: From baseline through study completion, an average of 1 year]
Критерии участия
Критерии включения
1\. Patients with missing central or lateral incisor
Критерии исключения
- inadequate edentulous space for the pontic
- signs of bruxism
- abutment tooth with active periodontal or periapical disease
- inadequate enamel bonding surface of the abutment tooth
- inadequate interocclusal space for a retainer wing and a proximal connector
- pontic guidance
- physical or psychological disease likely to interfere with normal conduct of the study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Словения · 1 центр
- Medical Faculty - University of Ljubljana Ljubljana — Ljubljana
Идентификаторы
NCT: NCT04693949 · Adhesion of RBFDPs