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.
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 8, 2021
CompletedFirst Posted
Study publicly available on registry
July 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedJuly 22, 2021
July 1, 2021
6 months
July 8, 2021
July 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in the maxillary arch
they will be measured in mm by digital models
T1 and T2 (4- 6 months)
Study Arms (2)
Presurgical vacuum formed nasoalveolar molding aligners group
EXPERIMENTALIn 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
EXPERIMENTALThis group will receive conventional Grayson acrylic formed nasoalveolar molding appliances without taping except some cases, with follow up every week for activation.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
Related Publications (1)
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.
PMID: 40830787DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fatma Abdu Abdelsayed, Professor
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- single blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Phd student, faculty of Dentistry, Cairo university
Study Record Dates
First Submitted
July 8, 2021
First Posted
July 19, 2021
Study Start
March 1, 2021
Primary Completion
September 1, 2021
Study Completion
March 30, 2022
Last Updated
July 22, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share