ART and Hall Technique for the Management of Occlusal-proximal Caries in Primary Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 主要终点
- The restoration survival (changes from baseline up to 36 months)
研究概览
简要总结
The aim of this, two-arm, parallel group, patient-randomised controlled, superiority trial is to evaluate the survival rate of approximal Atraumatic Restorative Treatment (ART) restorations compared to the Hall Technique (HT) placed in a school setting. The investigators will recruit 120 schoolchildren (5-10 years) with at least one occlusal-proximal carious lesion in primary molar. They will be randomized and treated following best-practice protocols to either receive an ART restoration using the high-viscosity glass ionomer cement (EQUIA Forte, capsules, GC Corp.) or a preformed metal crown placed using the HT (3M ESPE) cemented with glass ionomer luting cement (Fuji I Capsules, GC Corp.). Baseline measures and outcome data (at reviews over a three year period) will be assessed through participant report, clinical examination and parent report/ questionnaires.
详细描述
The selected children will be randomly allocated into 2 groups. The control group will comprise cavities treated by ART, following the protocol proposed by Frencken and Holmgren (1999), while the experimental group will comprise cavities treated by HT, according to the guideline published by Innes and Evans (2011). The allocation of patients in each group will be carried out by a random list generated by a specific computer program. To ensure the allocation concealment, the sequence generated by randomization will be distributed in opaque, sealed envelopes, which will be opened by the operator during the treatment, only after the patient is ready to receive treatment.
Operators will be two undergraduate students in dentistry and one experienced specialist in pediatric dentistry that will be trained on how to prepare and fill the cavities according to the original procedures of ART (Frencken and Holmgren, 1999) and also according to HT (Innes and Evans, 2011). The training will include a lecture about the techniques used in this study, as well as a workshop held in the laboratory for students to train handling and application of treatments to be tested. They will also undergo a week of training with patients, to apply the different techniques before starting the study, the latter phase held at the Faculty of Dentistry, University of São Paulo, under the supervision of an experienced dentist in ART and HT.
Each child will be allocated for one of the operators with the aid of a random list. All treatments will be performed on the school premises, in field conditions without the use of dental chair or other facilities from a clinical environment.
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
- None
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged between 5 and 10 years
- •cooperative behavior
- •presenting good health conditions
- •whose parents or legal guardians accept and sign the consent form
- •with at least one occluso-proximal lesion in primary molar
- •only occlusal-proximal surfaces with caries lesions with dentin involvement
- •cavities accessible to hand instruments used in ART
- •absence of fistula or abscess near the selected tooth
- •absence of pulp exposure in the selected tooth
- •absence of mobility in the selected tooth
- •cavity size in the selected tooth not be bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and bucco-lingual directions.
排除标准
- •children younger than 5 years and older than 10
- •non-cooperative behavior
- •without good health conditions
- •whose parents or legal guardians did not accepted and signed the consent form
- •without any occluso-proximal lesion in primary molar
- •caries in the selected tooth reaching other surfaces (than occlusal-proximal surface)
- •occlusal-proximal surface with caries without dentin involvement
- •cavities not accessible to hand instruments
- •fistula or abscess near the selected tooth
- •pulp exposure in the selected tooth
- •mobility in the selected tooth
- •cavity size bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and - bucco-lingual directions.
研究组 & 干预措施
Atraumatic Restorative Treatment
The cavity will be prepared according to the ART (Atraumatic Restorative Treatments) steps and filled with the dental material Glass Ionomer Cement without local anesthesia.
干预措施: Atraumatic Restorative Treatment (Procedure)
Hall Technique
The cavity will not receive any preparation. A stainless crown will be placed and cemented with the dental material Glass Ionomer Cement without local anesthesia.
干预措施: Hall Technique (Procedure)
结局指标
主要结局
The restoration survival (changes from baseline up to 36 months)
时间窗: The treatments will be evaluated after 1 week up to 36 months
The treatments will be classified "success" when they present clinical satisfactory aspect, and the failures will be scored as "minor failures" and "major failures" (adapted from Innes et al., 2007). The minor failures will be those in which there is a defect in the restoration / crown, but it does not interfere with the tooth health. The major failures will be considered when there signs or symptoms of irreversible pulp damage, such as dental fistula / abscess, tooth fracture or failures that cannot be repaired .The ART-restorations and HT scored as satisfactory will be considered as "successful", while those presented minor and major failures will be considered as "failure".
次要结局
- Acceptance of children in relation to treatments performed.(Immediately after treatment (in the same appointment))
- Acceptance of parents in relation to treatments performed.(Immediately after treatment (in the same appointment))
- Occlusal vertical dimension assessment(The measurements will be done before treatment, immediately after treatment (in the same appointment) and at each check-up appointment (1, 2 and 3 weeks and 1, 6, 12, 18, 24, 30 and 36 months))
- Cost-effectiveness assessment(Up 36 months)
- Oral Health Quality of life (OHRQoL) assessment(Before the treatment and during the 6 months recall)
- Child self-reported discomfort(Baseline)
- Perception and concerns related to tooth appearance.(baseline up to 6 months)
研究者
Daniela Prócida Raggio
Associated Professor
University of Sao Paulo