Efficacy of Hall Technique in Atypical Lesions on Primary Teeth: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Clinical longevity of restoration
研究概览
简要总结
Atypical carious cavities could be defined as carious lesions in more than 2 surfaces of the same tooth. Dental practitioners have shown difficulties related to material's maintenance in such type of cavities and therefore, several treatment options have been used. However, most of them have shown a great failure percentage. A randomized clinical trial will be developed with the objective of assessing the Hall technique in comparison with the composite resin incremental technique in 364 primary molars' atypical carious lesions of children between 4 and 9 years old. Initially, two previously calibrated examiners will perform caries diagnosis by means of visual assessment and intraoral examination. Selected teeth will be randomly allocated into two groups. Teeth in the first group will be submitted to prefabricated stainless steel crowns treatment (Hall technique); and the other, to composite resin incremental technique, which will be always placed under rubber dam isolation. Lesions' clinical and radiographic follow-up will be conducted after 6 and 12 months.
Treatment's efficacy will be assessed by means of four main outcomes:
- Longevity, marginal adaptation, possible modification in patients' vertical dimension, and caries lesion progression;
- Patient-focused criteria (satisfaction, discomfort and quality of life impact);
- cost-efficacy; and
- Treatment-related parents', children' and operators' perception.
Other variables could be further analysed as secondary outcomes, such as techniques performing time among operators, impact of the socio-economic characteristics on restorations' longevity, and restorations' type impact on the antagonist tooth. Comparisons between groups will be addressed using the Kaplan-Meier survival test as well as Long-Rank test. Cox Regression will be used to enable the assessment of other variables' influence in the results. Significance value of 5% will be adopted for all analysis.
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
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children must have at least one molar with atypical caries lesion (involving more than two surfaces);
- •parents or legal guardians accept and sign the informed consent form.
排除标准
- •children with special needs and/or systematic diseases with oral impairment;
- •teeth with spontaneous painful symptoms or necrotized and teeth presenting restorations, sealants, developmental enamel defects, pulp exposure or other signs related to endodontic treatment.
研究组 & 干预措施
Hall Technique
single placement of stainless dental crowns on atypical cavities
干预措施: Dental Restoration with Stainless Crown (Other)
Composite Resin
single placement of composite resin on atypical cavities
干预措施: Dental Restoration with Composite Resin (Other)
结局指标
主要结局
Clinical longevity of restoration
时间窗: Change from baseline until 6 and 12 months
The clinical evaluation will be performed by the non-blinded examiners. The examiner will use the criteria proposed by Innes et al. (2007) for both interventions.
次要结局
- Caregivers' satisfaction with the treatment(Baseline and 6 months)
- Impact on children's quality of life (6-9 years old)(Baseline and 6 months)
- Children's perceptions about the treatment(Baseline, 6 and 12 months)
- Radiographical caries lesion progression(Baseline, 6 and 12 months)
- Marginal adaptation of the stainless steel crowns(Baseline, 6 and 12 months)
- Biofilm retention of the stainless steel crowns(Baseline, 6 and 12 months)
- Caregivers' perceptions about the treatment(Baseline, 6 and 12 months)
- Treatments' cost-efficacy(Through study completion (12 months))
- Impact on children's quality of life (4-5 years old)(Baseline and 6 months)
- Clinicians' perceptions about the treatment(Baseline, 6 and 12 months)
- Clinicians' satisfaction with the treatment(Baseline and 6 months)
- Change in patient's vertical dimension(Baseline, 30 days, 6 and 12 months)
- Antagonist's level of intrusion(Baseline, 6 and 12 months)
- Clinical caries lesion progression(Baseline, 6 and 12 months)
- Children's satisfaction with the treatment(Baseline and 6 months)
- Children self-reported discomfort(Baseline)
研究者
Jose Carlos P Imparato
PhD, Senior Lecturer
Faculty Sao Leopoldo Mandic Campinas