Clinical and Radiographic Evaluation of a New Bioactive Ionic Resin Material (ACTIVA™ BioACTIVE) Versus Compomer for Class II Restorations in Primary Molars: A Split Mouth Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Clinical evaluation
研究概览
简要总结
A clinical trial to evaluate a filling material (ACTIVA) and compare it to a traditional filling material (compomer) to restore decayed deciduous teeth in children
详细描述
A tooth decay in deciduous teeth has to be restored with proper filling material. ACTIVA™ BioACTIVE is a new filling material which has the ability to release and recharge fluoride in the oral cavity which is important for preventing further tooth decay. In this study we will compare this new filling material with Compomer (the traditional control filling material) by restoring decayed deciduous molars with one of the mentioned filling materials.
Both filling materials have no reported adverse effect and used regularly in the dental practice.
The treatment procedure is performed in healthy children from both genders with decayed deciduous molars aged between 5 to 10 years by one operator in the dental chair under local anesthesia in the department of pediatric dentistry and special care, Ghent University hospital, Ghent, Belgium.
At least 35 teeth is needed to demonstrate an effect. Each material is placed randomly based on randomization done by the computer. Each participant will receive both types of treatments, one type on each side of the mouth.
The participants will come back each six months to check the success of each treatment group by two trained dentists other than the operator. and to check whether the control group performs similar, better or worse than the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
During treatment, the type of filling material was concealed from the patient, and the patient had no information which material was used in each side of the mouth. The type of material was not mentioned in the patient's file. Instead, it was replaced by a combination which the outcomes assessors were not familiar with. The operator was also blinded for the type of restoration during tooth preparation and was informed only at the time of restoration placement. The purpose of this discretion was to ensure double blinding both at the patient, as well as the outcomes assessor level.
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children with American Society of Anesthesiologists (ASA) I score from both gender aged between three and ten years
- •Vital decayed deciduous molar with proximal enamel/dentine caries
- •At least one decayed tooth on each side of the mouth (split mouth)
- •Pt is treatable in the dental chair
- •Parents agreed to participate in the study and signed the informed consent
排除标准
- •Patients with medical conditions or systemic disease
- •Anxious or uncooperative patients who are not treatable in the dental chair
- •Any symptoms like: pain, swelling, abscess or fistula.
- •Extensive caries, dental developmental disturbance, pathological mobility, pulp exposure or indication for pulp therapy
- •Patients with one decayed tooth in the whole mouth (not split mouth)
研究组 & 干预措施
ACTIVA™ BioACTIVE
Restoring cavity using ACTIVA filling material
干预措施: ACTIVA™ BioACTIVE (Drug)
Compomer
Restoring cavity using compomer filling material
干预措施: Compomer (Drug)
结局指标
主要结局
Clinical evaluation
时间窗: 12 months follow-up
Check the filling clinically based on United States Public Health Ryge criteria by a blinded and calibrated assessor
Radiographic evaluation
时间窗: 12 months follow-up
Check the filling radiographically based on Rx photo by a blinded and calibrated assessor
次要结局
- Time needed to place the filling material(Immediately after each intervention)