"Evaluation of Clinical Performance and Success Rate of CAD/CAM Versus Conventional Band and Loop Space Maintainer Randomized Clinical Trial and in Vitro Study"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 主要终点
- The success rate of appliances in terms of survival time.
研究概览
简要总结
This study is to evaluate and compare CAD/CAM zircon space maintainer and conventional metal of band and loop space maintainers in terms of plaque deposits and gingival health and, the success rate of the appliances in terms of: survival time, cement loss and appliance breakage. And to compare both appliances in terms of patient satisfaction.
This study consists of two parts: in vivo part (split mouth RCT) and in vitro part:
In vivo study:
Its sample size was found to be (36) cases (i.e. 18 case per group). Sample size calculation was performed using G*Power version 3.1.9.7 Sample size will be increased by about 10% to compensate for the drop-out.
In this in vivo study split mouth will be randomly divided into two groups:
Group 1: Conventional metal band and loop space maintainer Group 2: CAD/CAM zircon band and loop space maintainer
In vitro study:
its sample size was found to be (24) samples (i.e. 8 samples per group). Sample size calculation was performed using G*Power version 3.1.9.7 Sample size will be increased by about 10% to compensate for the drop-out.
Grouping:
The zirconia specimen divided randomly into three groups according to type of cements:
Group 1: Self-adhesive resin cement Group 2: Resin-modified glass ionomer cement Group 3: Universal bioactive cement
详细描述
Introduction:
Primary teeth play an important role in the development and growth of a child. Although their role in esthetics, speech, eating, and to encourage normal function. The other main function of a primary tooth is to hold space for the permanent successor until it's time for eruption. This normal physiologic process can be affected due to early premature loss of primary molars, due to dental caries which may lead to mesial tipping or migration of large permanent molar teeth into the space created. This may result in loss of space leading to discrepancy of arch length, malocclusion, crowding of teeth, cross bite, impaction of permanent premolars, and supra-eruption of opposing tooth. The best approach to maintain arch space and to prevent malocclusion is to use a space maintainer. Band and loop has been used since long as a space maintainer with high success rates. But there are some disadvantages can be associated with space maintainers which include, loss of cement, solder failure, caries formation along the margins of the band, long construction time, and the possibility of metal allergy in some patients. These shortcomings in addition to the rising interest of esthetic dentistry augmented by advances in technology have led to the development of newer materials and designs in the fabrication of space maintainers such as fiber-reinforced composite resins (FRCR) as fixed space maintainers. Digital technologies such as CAD CAM technology and new materials are becoming popular, getting better and changing the way to therapy. The ceramic space maintainer seems to be a suitable alternative to the conventional band and loop space maintainer. The appliance is well tolerated by the patient and also gives the benefit of advanced aesthetics with improved strength and allowing the easiest way of debonding during eruption of permanent successors.
The aim of the current study is:
A) Primary Objective Evaluate and compare CAD/CAM zircon space maintainer and conventional metal of band and loop space maintainers in terms of plaque deposits (Plaque index), gingival health (Gingival index).
The success rate of appliances in terms of survival time, cement loss and appliance breakage.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Double
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged :
- •A-minimum:4years B-maximum: 7 years old
- •Patients who are medically free
- •Premature loss of bilateral primary molar.
- •Sound and healthy buccal and lingual surfaces of selected primary molars.
排除标准
- •Children with dental abnormalities (cross bite, open bite, and deep bite).
- •Parafunctional oral habits.
- •Carious lingual and buccal surfaces of primary molars.
- •Lack of patient/parent compliance and cooperation.
结局指标
主要结局
The success rate of appliances in terms of survival time.
时间窗: Up to 12 months
Clinical evaluation of success rates of the modalities regarding survival time by checking both space maintainers and identify if there is cement loss or breakage of the appliances during the follow up period.
Clinical success: Evaluate and compare CAD/CAM zircon space maintainer and conventional metal of band and loop space maintainers in terms of plaque deposits (Plaque index)
时间窗: Up to 12 months
Plaque index, that is running in a scale from 0 to 3 where 0 means no plaque,1 film of plaque adhering to free gingival margin,2 moderate accumulation of soft deposits on the tooth and gingival margin, and 3 means abundance of soft debris.
Clinical success: Evaluate and compare CAD/CAM zircon space maintainer and conventional metal of band and loop space maintainers in terms of Gingival health, by assessing the gingival index.
时间窗: up to 12 months
Gingival health, scores from 0 to 3 where 0 no inflammation, 1slight redness no bleeding on probing, 2 redness and bleeding on probing, and 3 severe inflammation with edema and ulceration to spontaneous bleeding,47 and patient satisfaction.
次要结局
- Compare both appliances in terms of patient satisfaction.(Up to 12 months)
研究者
sara Abdelkhalek hassan younes
assistant teacher
Ain Shams University