Bilateral Cleft Lip/Palate, Cleft Lip and Palate
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPresurgical vacuum formed nasoalveolar molding aligners
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.
DEVICEConventional Grayson acrylic formed nasoalveolar molding appliances
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
single blinded
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
Yes
Inclusion criteria
* Non-syndromic Infants with complete BCLP infants * Infants less than 1 month of age * Males and females. * Infants with displaced premaxilla * Patients whose parents provided written consent for the study.
Exclusion criteria
* Patients above 1 month of age * Syndromic and systemically ill infants. * Patients with unilateral cleft lip and palate. * Incomplete Cleft lip. * Medically compromised patients * Patient's/guardians who will be unwilling to go through the PNAM therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the maxillary arch | T1 and T2 (4- 6 months) | they will be measured in mm by digital models |
Countries
Egypt
Contacts
Primary ContactKhadega Ali Al Khateeb, PhD
Backup ContactMohamed Abd El-Ghafour, Lecturer
Outcome results
None listed