COMPARATIVE EVALUATION OF DIGITAL AND TRAY IMPRESSION TECHNIQUE AS A METHOD OF RECORDING ANATOMICAL DETAILS OF CLEFT LIP AND PALATE IN NEONATES –A RANDOMIZED CONTROLLED CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Accuracy of digital and tray impression as a method of recording cleft lip and palate (Veaus Class III) in neonates
研究概览
简要总结
This study is an open, parallel group, randomized controlled clinical trial evaluating digital and tray impression technique as a method for recording anatomical details of cleft lip and palate in neonates. The study will be conducted on 16 neonates of 1-15 days old with cleft lip and palate {Veau’s class III) reporting to the department of Pediatric and Preventive Dentistry. The primary outcome is to evaluate accuracy of anatomical details of cleft lip and palate recorded using digital and tray impression technique and adaptation of feeding plate fabricated using the same in cleft lip and palate neonates. Secondary outcome is to assess the perception of parents regarding digital and tray impression technique and operator anxiety during recording of impression using both the techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 15.00 Day(s)（—）
- 性别
- All
入选标准
- •Non syndromic male and female cleft lip and palate neonates of 1-15 days of age.
- •Veau’s Class III, cleft lip and palate cases Moderate to well- nourished healthy infants (birth weight ≥ 2500gm).
排除标准
- •Cleft associated with other anomalies and syndromes Systemically compromised infants Parents/ guardian not willing to participate in the study.
结局指标
主要结局
Accuracy of digital and tray impression as a method of recording cleft lip and palate (Veaus Class III) in neonates
时间窗: 18months
Adaptation of feeding plate fabricated using digital and tray impression technique
时间窗: 18months
次要结局
- To assess the perception of parents regarding digital and tray impression technique and operator anxiety during recording of impression using both the techniques.(18months)