Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either presurgical vacuum-formed nasoalveolar molding aligners VF (NAM) or conventional Grayson acrylic formed nasoalveolar molding appliances in order to evaluate their effect on the maxillary arch.
The aim of this trial is to evaluate and compare the short-term effect of VF (NAM) aligners with conventional Grayson appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards maxillary arch changes. Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive presurgical vacuum-formed nasoalveolar molding aligners while the second group will receive conventional Grayson acrylic formed nasoalveolar molding appliances. The follow-up period will be 4-6 months till surgical lip closure. The changes in the maxillary arch will be assessed by digital maxillary models.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
at first visit, the infants will receive this appliance which is a maxillary vacuum plate incorporated with palatal screw, the infant's parents will be instructed to activate the screw and apply horizontal tap which will be placed at the base of nose in order to approximate lip segments and to change tape daily. After that, The infants will be recalled one week after the first visit to add the nasal stents into the appliance.
at first visit, the infants will receive this appliance which is a maxillary acrylic plate without adding taping, the infants will be recalled bi weekly for activating the appliance. When the cleft alveolar gap is reduced to 6mm or less, a pair of nasal stents will be added to mold the nasal cartilage. the infants will be followed up for 4-6 months.
Cairo University
Cairo, Egypt
RECRUITINGChanges in the maxillary arch
they will be measured in mm by digital models
Time frame: T1 and T2 (4- 6 months)
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