Back to resultsEffectiveness of Two Maxillary Expanders in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate
Primary Purpose
Cleft Lip and Palate, Maxillary Expansion
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Maxillary Expansion
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Lip and Palate
Eligibility Criteria
Inclusion Criteria:
- Mixed dentition stage;
- Both males and females;
- Lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age;
- Presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft;
- Permanent first maxillary molars present;
- Good periodontal health;
- No previous orthodontic treatment; and
Exclusion Criteria:
- Presence of a syndrome in companion with the present cleft defect.
- Previous secondary alveolar bone grafting.
- Taking medications affecting growth.
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Quadhelix Group
Hyrax Group
Arm Description
Outcomes
Primary Outcome Measures
Maxillary Expansion
Amount of Maxillary Expansion to be measured as distances (mm) on CBCTs and dental models.
Maxillary Expansion
mount of Maxillary Expansion to be measured as angles (degrees) on CBCTs and dental models.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04331977
Brief Title
Effectiveness of Two Maxillary Expanders in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate
Official Title
Effectiveness of Two Rapid Maxillary Expanders (Quadhelix vs Hyrax) in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 2, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This randomized controlled trial is designed to compare between quadlelix appliance vs hyrax expander regrading the their effectiveness in maxillary expansion in patients with cleft.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate, Maxillary Expansion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quadhelix Group
Arm Type
Experimental
Arm Title
Hyrax Group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Maxillary Expansion
Intervention Description
2 appliances to expand the maxillary arch
Primary Outcome Measure Information:
Title
Maxillary Expansion
Description
Amount of Maxillary Expansion to be measured as distances (mm) on CBCTs and dental models.
Time Frame
6 months
Title
Maxillary Expansion
Description
mount of Maxillary Expansion to be measured as angles (degrees) on CBCTs and dental models.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Mixed dentition stage;
Both males and females;
Lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age;
Presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft;
Permanent first maxillary molars present;
Good periodontal health;
No previous orthodontic treatment; and
Exclusion Criteria:
Presence of a syndrome in companion with the present cleft defect.
Previous secondary alveolar bone grafting.
Taking medications affecting growth.
Facility Information:
Facility Name
Faculty of Dentistry
City
Cairo
State/Province
Giza
ZIP/Postal Code
00202
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effectiveness of Two Maxillary Expanders in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate
We'll reach out to this number within 24 hrs