Alt-RAMEC Expansion and Protraction by EDO in Cleft Lip and Palate Patient
Primary Purpose
Cleft Lip and Palate
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Maxillary Expander with Differential Opening (EDO)
Petit Face Mask
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Lip and Palate focused on measuring Alt-RAMEC, expansion, cleft lip and palate patient, cone beam computed tomography (CBCT), protraction, facemask, MAXILLARY EXPANDER WITH DIFFERENTIAL OPENING (EDO)
Eligibility Criteria
Inclusion Criteria:
- Patients of both sexes.
- Cleft lip and palate patients.
- All patient age ranges from 8 to 12 years.
- All the cases showed maxillary arch constriction and deficiently
- All patients had maxillary permanent first molars.
- Primary lip adhesion and palatal closure.
Exclusion Criteria:
Patients had received any surgical assisted expansion or maxillary protraction or fixed orthodontics before.
2. Maxillary dentition unsuitable to bond the expander (less than two dental unit bedside first permanent molar) .
3. Absent maxillary permanent first molars. 4. Uncooperative patients/parents
Sites / Locations
- faculty of dental medicine for Girls, Al- Azhar UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cleft lip and palate patient
Arm Description
Clefts patient with transverse maxillary constriction and anteroposterior deficiency
Outcomes
Primary Outcome Measures
change in 3D dimension of skull after and before expansion
Full skull Cone Beam Computerized Tomography
Secondary Outcome Measures
Full Information
NCT ID
NCT04970095
First Posted
July 16, 2021
Last Updated
July 20, 2021
Sponsor
Faculty of Dental Medicine for Girls
1. Study Identification
Unique Protocol Identification Number
NCT04970095
Brief Title
Alt-RAMEC Expansion and Protraction by EDO in Cleft Lip and Palate Patient
Official Title
Evaluation of Alt-RAMEC by EDO With Facemask in Patients With Cleft Lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty of Dental Medicine for Girls
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the treatment outcome of Alternate Rapid Maxillary Expansion and Constriction Alt-RAMEC protocol on patients with cleft lip and palate, using a differential opening expander and face mask which will be measured and recorded by cone beam computed tomography (CBCT).
Detailed Description
Cleft lip and palate are among the most common deformities in children.Clefts patient are usually having orofacial problems as missing or unerupted permanent teeth, alveolar bone defect, speech difficulty . Patients with cleft lip and palate (CLP) commonly have maxillary arch constriction (maxillary hypoplasia) and Class III malocclusions due to deficient of maxillary growth The upper jaw of patients with cleft palate will be expanded by Maxillary Expander with Differential Opening (EDO) with alternate rapid maxillary expansion and constriction (Alt-RAMEC) , which is opened by opening the expansion device by 1 mm per day for a week, then closing the device at a rate of 1 mm per day in the second week and so on alternately for 7 consecutive weeks after the completion of the expansion, the facemask device will be used to protraction of maxilla the measurement and difference before and after treatment will be assessment by cone beam computed tomography (CBCT). .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate
Keywords
Alt-RAMEC, expansion, cleft lip and palate patient, cone beam computed tomography (CBCT), protraction, facemask, MAXILLARY EXPANDER WITH DIFFERENTIAL OPENING (EDO)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cleft lip and palate patient
Arm Type
Experimental
Arm Description
Clefts patient with transverse maxillary constriction and anteroposterior deficiency
Intervention Type
Device
Intervention Name(s)
Maxillary Expander with Differential Opening (EDO)
Intervention Description
The EDO is designed with two expansion screws positioned transversely. When more expansion is required between the canines, the anterior screw can be further activated. Both expansion screws can be activated to open in a parallel configuration. Pivoting corner screws allow for different amounts of expansion without significant risk of binding during activation.
Intervention Type
Device
Intervention Name(s)
Petit Face Mask
Intervention Description
The face mask is anatomical, multi-adjustable, lightweight and an ideal therapeutic alternative for the correction of Class III malocclusion.
consist of forehead cap chin cap cross bar
Primary Outcome Measure Information:
Title
change in 3D dimension of skull after and before expansion
Description
Full skull Cone Beam Computerized Tomography
Time Frame
six month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients of both sexes.
Cleft lip and palate patients.
All patient age ranges from 8 to 12 years.
All the cases showed maxillary arch constriction and deficiently
All patients had maxillary permanent first molars.
Primary lip adhesion and palatal closure.
Exclusion Criteria:
Patients had received any surgical assisted expansion or maxillary protraction or fixed orthodontics before.
2. Maxillary dentition unsuitable to bond the expander (less than two dental unit bedside first permanent molar) .
3. Absent maxillary permanent first molars. 4. Uncooperative patients/parents
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sarah s. kahlil, master
Phone
+201128899261
Email
sarahabdelaal.p5821@azhar.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed m. elabd, master
Phone
+201064244061
Email
sarahlala83@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
maha m. mohamed, phd
Organizational Affiliation
Lecturer of Orthodontics Department Faculty of Dental Medicine for Girls Al-Azhar University
Official's Role
Study Director
Facility Information:
Facility Name
faculty of dental medicine for Girls, Al- Azhar University
City
Cairo
State/Province
Nasr City
ZIP/Postal Code
0000
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohsena a. abdelrazq, phd
Phone
+201005839539
Email
MohsenaAhmad.el.8.383@azhar.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Evaluation of EDO ,Alt-RAMEC With Facemask in Patients With Cleft lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT)
Citations:
PubMed Identifier
27692413
Citation
Garib D, Lauris RC, Calil LR, Alves AC, Janson G, De Almeida AM, Cevidanes LH, Lauris JR. Dentoskeletal outcomes of a rapid maxillary expander with differential opening in patients with bilateral cleft lip and palate: A prospective clinical trial. Am J Orthod Dentofacial Orthop. 2016 Oct;150(4):564-574. doi: 10.1016/j.ajodo.2016.05.006.
Results Reference
background
PubMed Identifier
33754882
Citation
Singh S, Batra P, Raghavan S, Sharma K, Srivastava A. Evaluation of Alt-RAMEC With Facemask in Patients With Unilateral Cleft lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT) and Finite Element Modeling-A Clinical Prospective Study. Cleft Palate Craniofac J. 2022 Feb;59(2):166-176. doi: 10.1177/10556656211000968. Epub 2021 Mar 23.
Results Reference
background
Links:
URL
https://www.greatlakesdentaltech.com/maxillary-expander-with-differential-opening-edo.html
Description
Maxillary Expander with Differential Opening (EDO)
Learn more about this trial
Alt-RAMEC Expansion and Protraction by EDO in Cleft Lip and Palate Patient
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