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Effectiveness of the novel impression tray "cleftray" for infants with cleft lip and palate: a randomized controlled
Ritesh Kalaskar1, Priyanka Bhaje1, Shruti Balasubramanian1
1Department of Pediatric and Preventive Dentistry, Nagpur, India.
Insights
Novel impression trays significantly improve the process of creating feeding plates for infants with cleft lip and palate (CLP). These trays reduce procedure time and material use, offering a superior alternative to traditional methods for infant CLP care.
Area of Science:
- Craniofacial anomalies
- Pediatric dentistry
- Medical device innovation
Background:
- Cleft lip and palate (CLP) is a common congenital deformity impacting infant feeding.
- Feeding plates are essential prosthetics for infants with CLP to facilitate oral feeding.
- Accurate impressions are critical for effective feeding plate fabrication.
Purpose of the Study:
- To compare the effectiveness of novel impression trays against the traditional finger technique for infants with CLP.
- To evaluate the efficiency and clinical outcomes of different impression methods.
Main Methods:
- A randomized controlled trial involving 30 infants with CLP.
- Two groups were formed: one using the traditional finger technique and the other using a specialized acrylic tray (Cleftray).
Main Results:
- The Cleftray group demonstrated reduced impression time and material usage.
- No cyanosis or choking incidents were observed with Cleftray, and doctor anxiety was lower.
- Cleftray provided accurate impressions without distortion, capturing fine details like maxillary tuberosity.
Conclusions:
- Impression trays, such as Cleftray, are superior to traditional methods for recording CLP impressions.
- Further large-scale clinical trials are recommended to validate these findings across diverse parameters.
Objectives:
Cleft lip and palate (CLP) is one of the most common congenital deformities with worldwide prevalence. It causes a range of issues for infants that mainly involve difficulty in feeding due to abnormal oronasal communication. For this purpose, feeding plates are provided to infants to act as an artificial palate to aid in feeding. The most crucial procedure in fabrication of a feeding plate is creation of the impression using the traditional finger technique or impression trays. This preliminary research aims to compare the effectiveness of novel impression trays with that of the traditional finger technique for recording impressions of infants with CLP.
Materials And Methods:
This randomized controlled trial was conducted among 30 infants who were divided into two groups based on the method of obtaining impressions: Group I, finger technique; Group II, specialized acrylic tray (cleftray).
Results:
Use of cleftray required less impression time, a reduced amount of material, no incidence of cyanosis/choking in infants, and lower anxiety among doctors compared to the traditional method. Additionally, there was no distortion of cleft impressions, recorded maxillary tuberosity, or other fine details. Therefore, the novel impression tray (cleftray) exhibited superior outcomes in all the parameters compared to the finger technique.
Conclusion:
Within the limitations of this study, we conclude that impression trays are superior to the traditional finger, spoon, or ice cream stick methods of creating impressions of CLP. However, it is necessary to conduct more clinical trials on a larger population based on other parameters to compare the effectiveness of the two techniques to draw definitive conclusions.
