Back to resultsEffects of Skeletally Anchored Maxillary Expander Via Two Approaches of Microosteoperforations
Primary Purpose
Posterior Crossbite
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
skeletally anchored maxillary expander
Sponsored by
About this trial
This is an interventional treatment trial for Posterior Crossbite
Eligibility Criteria
Inclusion Criteria:
All patients should satisfy the following criteria:-
- An age range from 18-22.
- Transverse maxillary deficiency.
- Crossbite (unilateral or bilateral)
- No previous orthodontic treatment.
- Good oral and general health.
- No systemic disease/ medication that could interfere with OTM.
Exclusion Criteria:
- History of systemic and medical illness.
- History of extraction of permanent teeth.
- Previos orthodontic treatment.
- Poor oral hygiene or periodontally compromised patient.
- Patient with craniofacial anomaly or previous history of trauma,bruxism or parafunctions.
Sites / Locations
- Al-Azhar univesity
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
skeletal expander with microosteoperforation in mid palatine
skeletal expander with microosteoperforation in mid palatine and buccally
Arm Description
group1.will include ten patients undergo skeletally anchored maxillary expander with microosteoperforation in mid palatine suture
group2.will include ten patients undergo skeletally anchored maxillary expander with microosteoperforation in mid palatine suture and buccally
Outcomes
Primary Outcome Measures
skeletally transverse measurement
using cone beam computed tomography
dentolinear measurement
using cone beam computed tomography
dentoangular measurement
using cone beam computed tomography
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05433038
Brief Title
Effects of Skeletally Anchored Maxillary Expander Via Two Approaches of Microosteoperforations
Official Title
Dento-skeletal Effects of Skeletally Anchored Maxillary Expander Assisted With Two Approaches of Microosteoperforations
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
April 20, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
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
study will be directed to evaluate two approaches of microosteoperforations during skeletally anchored maxillary expansion
Detailed Description
Dento-skeletal effects of skeletally anchored maxillary expander assisted with two approaches of microosteoperforations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Crossbite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
skeletal expander with microosteoperforation in mid palatine
Arm Type
Active Comparator
Arm Description
group1.will include ten patients undergo skeletally anchored maxillary expander with microosteoperforation in mid palatine suture
Arm Title
skeletal expander with microosteoperforation in mid palatine and buccally
Arm Type
Active Comparator
Arm Description
group2.will include ten patients undergo skeletally anchored maxillary expander with microosteoperforation in mid palatine suture and buccally
Intervention Type
Device
Intervention Name(s)
skeletally anchored maxillary expander
Other Intervention Name(s)
mini implant assisted rapid palatine expander
Intervention Description
used from day one and activated two times per day for two weeks
Primary Outcome Measure Information:
Title
skeletally transverse measurement
Description
using cone beam computed tomography
Time Frame
from start of treatment until study completion an average of 1 year
Title
dentolinear measurement
Description
using cone beam computed tomography
Time Frame
from start of treatment until study completion an average of 1 year
Title
dentoangular measurement
Description
using cone beam computed tomography
Time Frame
from start of treatment until study completion an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients should satisfy the following criteria:-
An age range from 18-22.
Transverse maxillary deficiency.
Crossbite (unilateral or bilateral)
No previous orthodontic treatment.
Good oral and general health.
No systemic disease/ medication that could interfere with OTM.
Exclusion Criteria:
History of systemic and medical illness.
History of extraction of permanent teeth.
Previos orthodontic treatment.
Poor oral hygiene or periodontally compromised patient.
Patient with craniofacial anomaly or previous history of trauma,bruxism or parafunctions.
Facility Information:
Facility Name
Al-Azhar univesity
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Effects of Skeletally Anchored Maxillary Expander Via Two Approaches of Microosteoperforations
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