The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents' satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve and facilitate the surgical procedure after lip closure. This might decrease the need of further interventions to improve esthetics and function of CLP patients. This trial will help the patients and practitioners in taking the decision of inclusion of NAM in the CLP treatment protocol as a mandatory step or skip a useless procedure with all of its burden.
In this randomized trial, 4 groups will be included. The first group will receive a modified nasoalveolar molding appliance in addition to taping. In the second group, the patient will receive the CAD/NAM. the third group is tape only, while the fourth group remain untreated. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, photographs for nasal esthetics and interlabial gap outcome and maxillary models for the maxillary dimension change outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
63
Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is routine step in Grayson's nasoalveolar molding technique).
Infants will receive a tape only on the upper lip segments to mold it to touch each other.
computer aided design NAM
Faculty of Dentistry
Cairo, Egypt
Parents' satisfaction
It will be assessed using Questionnaire.
Time frame: 3 months
Nasal Esthetics: a- Nostril height
It will be measured in mm by Digital ruler on the images using a software.
Time frame: 3 months
Nasal Esthetics: b- Nostril width
It will be measured in mm by Digital ruler on the images using a software.
Time frame: 3 months
Nasal Esthetics: c- Nasal sill height
It will be measured in mm by Digital ruler on the images using a software.
Time frame: 3 months
Nasal Esthetics: d- Nostril area
It will be measured on the images in mm 2 (square) using a software measuring area.
Time frame: 3 months
Interlabial gap
It will be measured in mm by Digital ruler on the images using a software.
Time frame: 3 months
Maxillary Arch Dimension
It will be measured as distances in mm between landmarks identified on the dental models assessing the anterioposterior, transverse and vertical changes.
Time frame: 3 months
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