Early Correction of Skeletal Class II Division I by the Hybrid Aesthetic Functional Appliances
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Early correction of skeletal classII division I by the hybrid aesthetic functional appliances (HAF)
Study Overview
Brief Summary
use new hybrid aesthetic functional appliance for treatment of class II div 1 malocclusion.
Detailed Description
The Sample:
The sample size was calculated using PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.
A sample size of 16 data pairs achieves 80.3% power to reject the null hypothesis of zero effect size when the population effect size is 1.00 and the significance level (alpha) is 0.050 using a two-sided paired t-test.
The ten patients will be selected from the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Mansoura University.
The parents of each patient will be informed regarding the study and will sign written consent before starting the treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age included is the mixed dentition stage ( 6 -12 y )
- •skeletal Class II division
- •Overjet more than 4 mm.
Exclusion Criteria
- •Previous orthodontic treatment.
- •Bad oral hygiene.
Arms & Interventions
study group
use new device for treatment of class II malocclusion
Intervention: hybrid aesthetic functional appliance (Device)
Outcomes
Primary Outcomes
Early correction of skeletal classII division I by the hybrid aesthetic functional appliances (HAF)
Time Frame: one year
early treatment of class II division 1 malocclusion using HAF appliance and evaluate the skeletal and dental effect of new appliance by take cephalogram before and after treatments
Secondary Outcomes
No secondary outcomes reported
Investigators
Sohaila Adnan
Principal Investigator
Mansoura University