Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Grayson Acrylic Formed Nasoalveolar Molding Appliances.
NCT ID: NCT04966572
Last Updated: 2021-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2021-03-01
2022-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Presurgical vacuum formed nasoalveolar molding aligners group
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
Presurgical 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.
conventional Grayson acrylic formed nasoalveolar molding appliances group
This group will receive conventional Grayson acrylic formed nasoalveolar molding appliances without taping except some cases, with follow up every week for activation.
Conventional 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.
Interventions
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Presurgical 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.
Conventional 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Day
1 Month
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Khadega Ali Al Khateeb
Phd student, faculty of Dentistry, Cairo university
Principal Investigators
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Fatma Abdu Abdelsayed, Professor
Role: STUDY_DIRECTOR
Cairo University
Locations
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Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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BCLP_ Grayson_ vacuum
Identifier Type: -
Identifier Source: org_study_id
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