Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Presurgical vacuum formed nasoalveolar molding aligners group | Experimental | In this group, all patients will receive 1-2 VF-NAM aligners incorporated with palatal screw in addition to taping from day 1 for 4-6 Months with follow-up every 3 weeks |
|
| conventional Grayson acrylic formed nasoalveolar molding appliances group | Experimental | This group will receive conventional Grayson acrylic formed nasoalveolar molding appliances without taping except some cases, with follow up every week for activation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Presurgical vacuum formed nasoalveolar molding aligners | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the maxillary arch | they will be measured in mm by digital models | T1 and T2 (4- 6 months) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khadega Ali Al Khateeb, PhD | Contact | 00201100739869 | khadejaalkhateeb@yahoo.com | |
| Mohamed Abd El-Ghafour, Lecturer | Contact | 00201007433288 | m.abdelghafour@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Fatma Abdu Abdelsayed, Professor | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40830787 | Derived | Al-Khateeb KA, Aboulfotouh MH, Abdelsayed F, Mohamed W, Abd-El-Ghafour M. Three-dimensional assessment of maxillary arch changes in infants with bilateral cleft lip and palate using vacuum-formed nasoalveolar molding with active screw versus conventional nasoalveolar molding appliances: a randomized clinical trial. BMC Oral Health. 2025 Aug 19;25(1):1339. doi: 10.1186/s12903-025-06607-w. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
single blinded
|
| Conventional Grayson acrylic formed nasoalveolar molding appliances | Device | 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. |
|
| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided