Back to resultsEvaluation Of Different Rapid Orthodontic Expansion Devices
Primary Purpose
Cross Bite
Status
Completed
Phase
Phase 1
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Rapid Expansion of palatal suture
Sponsored by
About this trial
This is an interventional treatment trial for Cross Bite
Eligibility Criteria
Inclusion Criteria:
- Non-syndromic adolescent patients.
- Patients in need for palatal expansion treatment.
- Average face height.
- No previous orthodontic treatment.
Exclusion Criteria:
- Syndromic adolescent patients.
- Patients not in need for palatal expansion treatment.
- Non-average face height.
- Previous orthodontic treatment.
Sites / Locations
- King Abdulaziz University, Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Haas group (H)
Hyrax (Hx)
Miniscrew-supported (MHx)
Arm Description
Rapid Expansion of palatal suture device: tooth-tissue supported expander (Haas (H)).
Rapid Expansion of palatal suture device: tooth anchored expander (Hyrax (Hx)).
Rapid Expansion of palatal suture device: bone anchored expander (Temporary anchorage devices(miniscrew)-supported (MHx))
Outcomes
Primary Outcome Measures
Amount of skeletal and dental expansion
These are linear measurements which will be measured in millimetres in the first and the second cone beam computed tomography images and the difference will be calculated.
Amount of dental inclination
These are angular measurements which will be measured in degrees in the first and the second cone beam computed tomography images and the difference will be calculated.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03258411
Brief Title
Evaluation Of Different Rapid Orthodontic Expansion Devices
Official Title
Comparison of The Short Term Effects of Different Palatal Expanders Using CBCT.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 10, 2015 (Actual)
Primary Completion Date
February 5, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdulaziz University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluating and comparing the short term effects of different palatal expanders on the amount of palatal expansion and buccal tipping of posterior teeth.
Hypothesis:
H0: There is no difference in the short term effects between the different palatal expanders.
H1: There is a significant difference in the short term effects between the different palatal expanders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cross Bite
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Haas group (H)
Arm Type
Active Comparator
Arm Description
Rapid Expansion of palatal suture device: tooth-tissue supported expander (Haas (H)).
Arm Title
Hyrax (Hx)
Arm Type
Active Comparator
Arm Description
Rapid Expansion of palatal suture device: tooth anchored expander (Hyrax (Hx)).
Arm Title
Miniscrew-supported (MHx)
Arm Type
Active Comparator
Arm Description
Rapid Expansion of palatal suture device: bone anchored expander (Temporary anchorage devices(miniscrew)-supported (MHx))
Intervention Type
Device
Intervention Name(s)
Rapid Expansion of palatal suture
Primary Outcome Measure Information:
Title
Amount of skeletal and dental expansion
Description
These are linear measurements which will be measured in millimetres in the first and the second cone beam computed tomography images and the difference will be calculated.
Time Frame
3 months
Title
Amount of dental inclination
Description
These are angular measurements which will be measured in degrees in the first and the second cone beam computed tomography images and the difference will be calculated.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-syndromic adolescent patients.
Patients in need for palatal expansion treatment.
Average face height.
No previous orthodontic treatment.
Exclusion Criteria:
Syndromic adolescent patients.
Patients not in need for palatal expansion treatment.
Non-average face height.
Previous orthodontic treatment.
Facility Information:
Facility Name
King Abdulaziz University, Faculty of Dentistry
City
Jeddah
State/Province
Makkah
ZIP/Postal Code
21589
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26432315
Citation
Mosleh MI, Kaddah MA, Abd ElSayed FA, ElSayed HS. Comparison of transverse changes during maxillary expansion with 4-point bone-borne and tooth-borne maxillary expanders. Am J Orthod Dentofacial Orthop. 2015 Oct;148(4):599-607. doi: 10.1016/j.ajodo.2015.04.040.
Results Reference
background
PubMed Identifier
20197161
Citation
Lagravere MO, Carey J, Heo G, Toogood RW, Major PW. Transverse, vertical, and anteroposterior changes from bone-anchored maxillary expansion vs traditional rapid maxillary expansion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):304.e1-12; discussion 304-5. doi: 10.1016/j.ajodo.2009.09.016.
Results Reference
background
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Evaluation Of Different Rapid Orthodontic Expansion Devices
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