跳至主要内容
临床试验/CTRI/2023/10/058547
CTRI/2023/10/058547已完成2 期

Comparative evaluation of clinical performance of 3D printed space maintainer using PEEK polymer with that of prefabricated stainless steel space maintainer-An In-vivo study

JAHANA SHERIN IM1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年10月20日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
CLINICAL SUCCESS RATE OF 3D PRINTED SPACE MAINTAINER AND PREFABRICATED SPACE MAINTAINER IN PEDIATRIC DENTISTRY INTERMS OF PLAQUE INDEX, GINGIVAL INDEX, RETENTION AND SURVIVAL TIME

研究概览

简要总结

The study’s aim is to compare and evaluate the clinical performance of 3D printed space maintainer using PEEK polymer with that of prefabricated stainless steel space maintainer. The result of the study will give additional information regarding the potential use of PEEK polymer material in fabrication of space maintainer.

It is an in-vivo experimental study with 15 children of age group 6-9 years reporting to dept. of pediatric and preventive dentistry, Yenepoya Dental College, who has two posterior edentulous spaces and indicated for space maintainers.

The study will be commenced only after approval from the institutional ethical committee. Once inclusion and exclusion criteria are satisfied consent from parents and child will be obtained prior to the study.

Impressions of upper and lower arch will be made using rubber-based impression material and then Casts will be poured. The cast will be sent to 3D lab at Yenepoya Incubation Centre for the fabrication of 3D space. And then the appliance will be sterilized according to standard sterilization protocol. Prefabricated space maintainer will be adapted on one edentulous space according to user instructions and 3D designed space maintainer using PEEK will be fixed on the other edentulous space. Both the space maintainers will be luted by using resin modified GIC.

All the procedure will be carried out by single operator. At the end of 6 months, patient will be recalled and parameters like plaque index, gingival index, survival time, patient satisfaction will be evaluated and documented. The above results will be subjected to statistical analysis.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Not Applicable

入排标准

年龄范围
6.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Children of age group 6-9 years with two posterior edentulous spaces due to premature loss of deciduous molars and indicated for space maintainer.

排除标准

  • Medically compromised patients Patients with high caries index Children with dental abnormalities (cross bite/open bite/deep bite) Children with loss of space.

结局指标

主要结局

CLINICAL SUCCESS RATE OF 3D PRINTED SPACE MAINTAINER AND PREFABRICATED SPACE MAINTAINER IN PEDIATRIC DENTISTRY INTERMS OF PLAQUE INDEX, GINGIVAL INDEX, RETENTION AND SURVIVAL TIME

时间窗: 6 months

次要结局

  • CLINICAL SUCCESS RATE OF 3D PRINTED SPACE MAINTAINER AND PREFABRICATED SPACE MAINTAINER IN PEDIATRIC DENTISTRY INTERMS OF PATIENTS SATISFACTION USING VISUAL ANALOGUE SCALE(end of 6 months)

研究者

发起方
JAHANA SHERIN IM
申办方类型
Other [self]

研究点 (1)

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