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.
Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Conventional Grayson Acrylic Formed Nasoalveolar Molding Appliances: A Randomized Clinical Trial
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Khadega Ali Al Khateeb, PhD
- Phone Number: 00201100739869
- Email: khadejaalkhateeb@yahoo.com
Study Contact Backup
- Name: Mohamed Abd El-Ghafour, lecturer
- Phone Number: 00201007433288
- Email: m.abdelghafour@dentistry.cu.edu.eg
Study Locations
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Cairo, Egypt
- Recruiting
- Cairo University
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Contact:
- Mohamed Abd El-Ghafour, lecturer
- Phone Number: 00201007433288
- Email: m.abdelghafour@dentistry.cu.edu.eg
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Contact:
- Mai Aboul Fotouh, lecturer
- Phone Number: 00201001884499
- Email: mai.aboulfotouh@dentistry.cu.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
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.
|
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Experimental: 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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in the maxillary arch
Time Frame: T1 and T2 (4- 6 months)
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they will be measured in mm by digital models
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T1 and T2 (4- 6 months)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCLP_ Grayson_ vacuum
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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