Patient-centred, Developmental and Quality-of-life Outcomes Following Zirconia Crown Restoration Versus Extraction of Severely Mutilated Primary Anterior Teeth: a Pragmatic Comparative Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Change in Oral Health-Related Quality of Life (OHRQoL)
研究概览
简要总结
Severely mutilated anterior primary teeth in preschool children are frequently managed by extraction. However, premature loss of anterior primary teeth has been associated with adverse functional, developmental and psychosocial outcomes, including impaired oral health-related quality of life (OHRQoL), speech concerns and negative self-image.
Prefabricated zirconia crowns offer an aesthetic and durable restorative alternative for compromised anterior primary teeth. Despite increasing clinical use, comparative evidence evaluating zirconia crown restoration versus extraction under equivalent conditions using validated patient-centred, developmental and economic outcomes remains limited.
This pragmatic, prospective, non-randomised controlled clinical study aims to compare zirconia crown restoration and extraction of severely mutilated anterior primary teeth performed under GA in preschool children. Outcomes include OHRQoL, parental satisfaction, child self-image, and speech development.
详细描述
Early childhood caries (ECC) remains one of the most prevalent chronic conditions in preschool children. Management of decayed anterior primary teeth is particularly challenging due to young age, limited cooperation and extensive tooth destruction. As a result, extraction is often selected as a definitive treatment.
However, systematic and rapid reviews have demonstrated associations between premature loss of primary anterior teeth and adverse outcomes, including reduced OHRQoL, speech distortion, altered oral habits and psychosocial impacts. These reviews have consistently highlighted the need for prospective, patient-centred studies employing validated outcome measures and addressing methodological limitations of earlier research.
Prefabricated zirconia crowns have emerged as an aesthetic and durable restorative option for anterior primary teeth. While clinical success and parental acceptance have been reported, direct comparisons with extraction that incorporate patient-centred outcomes and economic evaluation are scarce.
This study addresses these gaps by prospectively comparing zirconia crown restoration and extraction of decayed anterior primary teeth, using validated OHRQoL, parental satisfaction, child self-image and speech development.
Study Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •Children aged 3-5 years
- •Presence of one or more decayed primary anterior teeth
- •Written informed consent from parent or legal guardian
排除标准
- •Craniofacial anomalies or genetic syndromes
- •Diagnosed developmental delay or speech disorders
- •Previous speech therapy
- •Systemic disease contraindicating general anaesthesia
结局指标
主要结局
Change in Oral Health-Related Quality of Life (OHRQoL)
时间窗: 1 month and 3 months
* Measurement Tool: Early Childhood Oral Health Impact Scale (ECOHIS), parent-reported * Time Frame: Baseline (pre-treatment), 1 month post-treatment, 3 months post-treatment (primary endpoint) * Units: Total score (0-52) and domain scores * Description: Higher scores indicate poorer OHRQoL
次要结局
- 1. Parental Satisfaction(1 month and 3 months)
- 2. Child Self-Image(1 month and 3 months)
- 3. Speech Development(1 month and 3 months)
研究者
Passant Nagy
Associate Professor
Cairo University