Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth - Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Survival of restoration
研究概览
简要总结
Atypical cavities, which involve more than two surfaces being one of them vestibular or lingual/palatine, are a challenge for restorative dentistry, since the risk of failure of the restorations are related to the number of surfaces involved. Thus, the objective of this project is to conduct a randomized clinical trial in order to evaluate the efficacy and patient-centered outcomes of a chemically-activated alkasite composite resin in atypical lesions of deciduous molars. Deciduous molars of children between 4 and 7 years of age with at least one atypical cavity lesion in deciduous molars will be selected for the ECR. The selected teeth will be randomly divided into two groups: Chemically activated composite resin Alkasite and resin-Modified glass ionomer cement. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The efficacy of the treatments will be evaluated by the longevity of the restoring procedures and the arrestment of the caries lesions. Patient-centered outcomes will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children will be included who have at least one posterior tooth with atypical caries lesion.
排除标准
- •Patients with special needs
- •Patients general health conditions that may affect the oral cavity
- •Patients non-cooperating in relation to the examination
- •Patients with orthodontic apparatus
- •The parents/guardians or children not to consent to their participation in the study.
- •Teeth with pulp exposure
- •Teeth with spontaneous pain
- •Teeth with mobility
- •Teeth with presence of swelling or fistula close to the tooth
- •Teeth with furcation or cervical injury
- •Teeth with restorations, sealants or enamel formation defects will be excluded.
研究组 & 干预措施
Chemically activated Composite resin Alkasite
Single placement of composite resin on atypical cavities.
干预措施: Dental Restoration with Chemically activated Composite resin Alkasite (Procedure)
Resin-Modified Glass ionomer Cement
Single placement of Resin-Modified Glass ionomer Cement on atypical cavities.
干预措施: Dental Restoration with Resin-Modified Glass ionomer Cement (Procedure)
结局指标
主要结局
Survival of restoration
时间窗: 12 months after treatment.
To evaluate the survival of restoration by clinical examination with FDI index.
次要结局
- Caries lesion progression(12 months after treatment.)
- Oral health-related quality of life(6 month of restorative treatment.)
- Child discomfort(Immediately after the treatment.)
- Secondary caries lesion or on the surface adjacent to the restored tooth(12 months after treatment.)
- Perception of children and parents/guardians(6 months after treatment.)
- Parents/Guardians Satisfaction(6 months after restoration.)
- Post Operative sensitivity of the child(7 ° day after the restorative procedure.)
- Operator perception(6 months after the restoration.)
研究者
Jose Carlos P Imparato
PhD in Pediatric Dentistry
Faculty Sao Leopoldo Mandic Campinas