Conservative Versus Non-conservative Treatment for Severe Dental Caries in Preschool Children and Its Impact on Oral Health-related Quality of Life, Anthropometric Measures, Space Loss and Anxiety: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- oral health-related quality of life
研究概览
简要总结
The purpose of this study is to compare the effectiveness of the conservative (pulpectomy) versus non-conservative treatment (tooth extraction) of primary molars affected with severe dental caries associated to oral health-related quality of life, anthropometric and clinical outcomes.
详细描述
Treatment: evaluate two interventions for treating severe dental caries in primary molared of preschool children.
SAMPLE: preschool children aged 3 to 5 years with severe dental caries (SDC) in primary molars. SDC will be indicated by the Pufa index. The Pufa index records the presence of severely decayed teeth with visible pulp involvement (p), ulceration of the oral mucosa owing to root fragments (u), fistula (f) and abscess (a). Children with pufa-score > 0 in primary molars will be included in the study. All children aged 3 to 5 years, who sought dental screening at the Dental School, University of São Paulo (USP) in August to October 2013 can be initially eligible.
CLINICAL GROUPS RANDOMLY ASSIGNED:
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Group A: Conservative treatment represented by pulpectomies + teeth restoration with composite resin crown.
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Group B: Dental extraction
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Treatment of carious teeth with pufa score =0 will receive dental fillings (01 occlusal surface affected: ART; 02 surfaces affected: composite resin; ≥ 03 surfaces affected: composite resin crown).
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One operator (specialists in paediatric dentistry) blinded to the outcomes will carry out the treatments.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preschool children with severe dental caries (SDC) in primary molars.
- •SDC will be indicated by the Pufa index
- •The Pufa index records the presence of severely decayed teeth with visible pulp involvement (p), ulceration of the oral mucosa owing to root fragments (u), fistula (f) and abscess (a). Children with a pufa-score > 0 will be included in the study.
排除标准
- •Children with severe crowding of anterior teeth
- •Severe arch length deficiencies
- •Children with systemic and neurological diseases or those with illnesses that adversely affect growth according to parents reports
- •Children on regular nutrition supplements
- •Children who had undergone dental treatment in the last three months and who were not willing to participate in the study. Tooth with anomalies, extensive crown destruction and impossibility of absolute isolation in the conservative intervention group.
结局指标
主要结局
oral health-related quality of life
时间窗: 12 months
- OHRQoL instruments: Brazilian SOHO-5 Brazilian ECOHIS
次要结局
- dental anxiety(12 months)
- anthropometric measures(12 months)
- Dental pain(12 months)
- loss of space(12 months)
研究者
Jenny Abanto
Post-doctoral student
University of Sao Paulo