Comparative Evaluation of Clinical Outcomes of Band and loop Space Maintainers: Prefabricated vs 3D Designed Zirconia in Children of Aged 4-10 years– Randomised Controlled Trial (Academic Trial)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To evaluate space maintenance efficiency of 3D Designed space maintainer versus Prefabricated band and loop space maintainer assessed by comparing the mesiodistal spaces pre- and post- 9 months follow-up (3, 6, 9 months) taken from intraoral scans.
研究概览
简要总结
This is a prospective, randomized, parallel clinical trial conducted in a pediatric dental setting. The study aims to compare the effectiveness of 3d Designed zirconia band and loop space maintainer and prefabricated band and loop space maintainer in children on aged 4 to10 years.participants are randomly allocated into two groups such as interventional group 3D Designed zirconia band and loop space maintainer and comparator group of prefabricated band and loop space maintainer of 23 each, evaluation of space maintainence efficiency and other clinical outcomes such as decementation, band breakage, loop breakage, secondary caries over 9 months at followup visits of 3, 6, 9, months. The study will help to identify the effective space maintainer for children. A total of 46 participants will be enrolled at a single centre in India
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •CLINICAL CRITERIA: 1.Child within the age group of 4-10 2.Single primary tooth loss requiring space maintenance programme 3.Otherwise healthy children 4.Sound abutment teeth RADIOGRAPHIC CRITERIA: 5.Presence of succedaneous tooth 6.Presence of more than 1mm bone covering succedaneous tooth radiographically 7.Less than two-thirds of root formation with succedaneous tooth.(Up to Nollas stage 8).
排除标准
- •1.Children with known systematic illness contraindicating placement of band and loop space maintainer 2.Grossly decayed abutment teeth 3.Cases requiring long band and loop space maintainer 4.High caries index 5.Children with poor oral hygiene 6.Multiple carious teeth in same quadrant 7.Prolonged loss of teeth which may need for any space regaining schedule 8.Abnormal sequence of eruption 9.Patient with developing class II and class III malocclusion 10.Presence or anticipated arch length and tooth size discrepancy 11.Otherwise abnormal functional and muscular oral activity.
结局指标
主要结局
To evaluate space maintenance efficiency of 3D Designed space maintainer versus Prefabricated band and loop space maintainer assessed by comparing the mesiodistal spaces pre- and post- 9 months follow-up (3, 6, 9 months) taken from intraoral scans.
时间窗: At the time of procedure, | At 3 months, | At 6 months, | At 9 months.
次要结局
- To analyse survival rates of other clinical outcomes (De-cementation, Loop Breakage, Band Breakage, & Secondary Caries) over 9 months (3, 6, 9 months).(At the time of procedure,)
- To evaluate most common type of failure associated with 3D Designed band & loop space maintainer & prefabricated band & loop space maintainer over 9 months(3, 6, 9 months).(At the time of procedure,)
研究者
Ginjupalli Laharee
AIIMS Mangalagiri