Comparison and evaluation of effectiveness and clinical performance of conventional space maintainer, preformed space maintainer , 3-D printed space maintainer and CAD/CAM space maintainer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- evaluate and compare the clinical effectiveness and survival rate of conventional, preformed, 3D-printed, and CAD/CAM space maintainers in pediatric patients over a 12-month follow-up period. This includes assessment of the appliance’s retention, stability, structural integrity, and ability to maintain the space for the eruption of permanent teeth
研究概览
简要总结
This clinical study is designed to assess and compare the performance of four different types of space maintainers used in pediatric dentistry – conventional, preformed, 3D printed, and CAD CAM fabricated. The trial will involve 60 children between the ages of 4 and 8 who require space maintenance due to early loss of primary molars. Participants will be randomly divided into four groups, each receiving one type of appliance. The devices will be monitored and evaluated at intervals of 1, 6, and 12 months to measure their effectiveness, durability, impact on gum health, and overall satisfaction from both children and their parents. The goal of the study is to determine which type of space maintainer provides the most reliable results and improved patient experience for long-term dental development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Grossly decayed single molars on either side/single side indicated for extraction.
- •2.Sound and healthy teeth adjacent to the extraction site 3.Presence of succedaneous tooth bud 4.No abnormal dental conditions such as crossbite, open bite, and deep bite 5.Presence of at least 1 mm bone overlying the succedaneous tooth germ with less than one- third of the root formed.
- •6.Parents who gave consent.
排除标准
- •1.Grossly carious tooth adjacent to the extraction site 2.Children whose parents refused to give consent 3.Presence of any systemic disease 4.Absence of teeth on the mesial or distal side of the teeth to be extracted 5.In cases of Space Loss.
结局指标
主要结局
evaluate and compare the clinical effectiveness and survival rate of conventional, preformed, 3D-printed, and CAD/CAM space maintainers in pediatric patients over a 12-month follow-up period. This includes assessment of the appliance’s retention, stability, structural integrity, and ability to maintain the space for the eruption of permanent teeth
时间窗: Follow up at baseline, 1 month, 6 months, and 12 months
次要结局
- Patient Comfort: Assessed via Likert Scale for patient/parent satisfaction with comfort levels for Conventional, Preformed, 3D Printed, and CAD/CAM space maintainers.(Material Durability: Evaluated for structural integrity (e.g., solder breakage, loop breakage, de-cementation) at 1, 6, and 12 months.)