Comparative evaluation of clinical success of conventional space maintainer versus prefabricated space maintainer in children aged 4 to 9 years - A split-mouth randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
In this split-mouth, randomized control trial, we aimed to compare the efficacy of two different space maintainers namely, conventional and pre fabricated space maintainer. The study will assess survival rate, gingival health, incidence of caries in the abutment tooth, amount of space loss between both the space maintainers. All the parameters are evaluated at baseline, 1 month, 3 months, 6 months and 9 months. The results of this trial will provide valuable insights into the impact of unilateral fixed space maintainers. aiding pedodontists in making informed decisions regarding the choice of space maintainer for improved patient outcomes and quality of care.
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 7.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical criteria: Systemically healthy children.
- •Grossly mutilated or resorbed primary molars bilaterally requiring extraction before the complete eruption of permanent mandibular anteriors.
- •Sound and healthy teeth adjacent to the extraction site.
- •No abnormal dental conditions such as crossbite, open bite, and deep bite.
- •Radiographic criteria: Presence of succedaneous tooth bud.
- •Presence of at least 1 mm bone overlying the succedaneous Tooth germ with less than one-third of the root formed.
排除标准
- •Parents who didn’t give consent Individuals having systemic diseases or severe medically compromised.
- •Grossly carious teeth were adjacent to the created space.
- •Absence of teeth on the mesial or distal side of the teeth to be extracted.
结局指标
主要结局
Survival rate
时间窗: Baseline, 1 month, 3 months, 6 months and 9 months
次要结局
- Gingival health, Incidence of caries in abutment tooth, Space loss(Baseline, 1 month, 3 months, 6 months and 9 months)
研究者
Ayesha Fathima
Saveetha Dental College