Evaluation of the Success Rate of Prefabricated Versus Conventional Band and Loop Space Maintainers in Children With Prematurely Lost First Primary Molars A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- appliance success
研究概览
简要总结
To assess the clinical efficacy of prefabricated space maintainers compared to conventional ones, focusing on preserving the integrity of each component of bands and loops, avoidance of soft tissue impingement as well as preservation of arch dimensions.
详细描述
Management of the developing occlusion lies firmly within the scope of pediatric dentistry, therefore protection of dental arch integrity and inter-arch relations in the premature loss of teeth can be guaranteed by placing space maintainers. Conventional appliances are used successfully as space maintainers, although they have some disadvantages.The need for at least two visits to delivery, therefore cannot be planned in patients under general anesthesia. Fabrication of conventional and loop requires an alginate impression and laboratory work.
Prefabricated band and loop devices have been introduced to dentistry in recent times. They can possibly overcome most of the previously mentioned limitations of conventional space maintainers. The prefabricated band and loop space maintainer is adjusted and applied in one visit and therefore can be planned in patients under general anesthesia. Other advantages include less time, more patient and parent satisfaction, and no laboratory work
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)
盲法说明
Blinding will not be feasible neither for the operator nor the patient. As there are some differences in the clinical steps, the form of the appliances and number of needed visits.
Outcome assessor and Statistician will be blinded from the intervention and control not knowing which group represents which procedure.
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical criteria Medically free children.
- •Patient and parent showing cooperation and compliance.
- •Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy.
- •Freshly extracted single molars unilaterally or bilaterally
- •Unilateral or bilateral loss of primary molars before or after the eruption of the first permanent molar
- •Caries free or restored the mandibular second primary molars and deciduous canines in the side of the extraction maintained throughout the entire follow-up period.
- •Radiographic criteria
- •Presence of succedaneous tooth bud.
- •Presence of at least 1 mm bone overlying the succedaneous tooth germ
- •1/3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars.
排除标准
- •• Children with any parafunctional habits.
- •Children with previous allergies to stainless steel.
- •Permanent successors with 2/3 of its roots formed and space analysis does not indicate the fabrication of space maintainer.
结局指标
主要结局
appliance success
时间窗: 0-3-9 month
evaluation of clinical success criteria ( • Integrity of each component of band and loop - solder breakdown - decementation - abutment fracture - Soft tissue impingement ) Clinical examination by operator ( binary yes or no )
次要结局
- arch dimension(0-9 month)
- • Patient satisfaction(during insertion of appliance)
- • Cost effectiveness(through study completion , an average of 9 month)
- Space loss between the abutment teeth.(0-9 month)
研究者
amal fathy mahmoud mohammed elsayed saker
principal investigator
Cairo University