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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Accuracy of digital and tray impression as a method of recording cleft lip and palate (Veaus Class III) in neonates
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 1.00 Day(s) to 15.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •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).
Exclusion Criteria
- •Cleft associated with other anomalies and syndromes Systemically compromised infants Parents/ guardian not willing to participate in the study.
Outcomes
Primary Outcomes
Accuracy of digital and tray impression as a method of recording cleft lip and palate (Veaus Class III) in neonates
Time Frame: 18months
Adaptation of feeding plate fabricated using digital and tray impression technique
Time Frame: 18months
Secondary Outcomes
- To assess the perception of parents regarding digital and tray impression technique and operator anxiety during recording of impression using both the techniques.(18months)