Effects of Skeletally Anchored Maxillary Expander Via Two Approaches of Microosteoperforations
Dento-skeletal Effects of Skeletally Anchored Maxillary Expander Assisted With Two Approaches of Microosteoperforations
1 other identifier
interventional
20
1 country
1
Brief Summary
study will be directed to evaluate two approaches of microosteoperforations during skeletally anchored maxillary expansion
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2022
CompletedFirst Submitted
Initial submission to the registry
June 22, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedJune 27, 2022
June 1, 2022
1.9 years
June 22, 2022
June 22, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
skeletally transverse measurement
using cone beam computed tomography
from start of treatment until study completion an average of 1 year
dentolinear measurement
using cone beam computed tomography
from start of treatment until study completion an average of 1 year
dentoangular measurement
using cone beam computed tomography
from start of treatment until study completion an average of 1 year
Study Arms (2)
skeletal expander with microosteoperforation in mid palatine
ACTIVE COMPARATORgroup1.will include ten patients undergo skeletally anchored maxillary expander with microosteoperforation in mid palatine suture
skeletal expander with microosteoperforation in mid palatine and buccally
ACTIVE COMPARATORgroup2.will include ten patients undergo skeletally anchored maxillary expander with microosteoperforation in mid palatine suture and buccally
Interventions
used from day one and activated two times per day for two weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Al-Azhar univesity
Cairo, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- BDS(2006),faculty of dental medicine suze canal university
Study Record Dates
First Submitted
June 22, 2022
First Posted
June 27, 2022
Study Start
May 20, 2022
Primary Completion
April 20, 2024
Study Completion
November 1, 2024
Last Updated
June 27, 2022
Record last verified: 2022-06