Effect of the Innovated Seifi's Functional Appliance on Skeletal and Dentoalveolar Changes of Class II/ 1, Deep Bite (Seifi-Fx)
Recruitment status was: Recruiting
Orthodontic Appliance Design
Malocclusion, Angle Class II
Device: Seifi's Functional
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 Effect of the Innovated Seifi's Functional Appliance on the Skeletal and Dentoalveolar Changes of Class II/Division 1, Deep Bite Cases|
- Overjet and Overbite [ Time Frame: 2-6 month depending on the amount of OJ and OB and the patient compliances ] [ Designated as safety issue: Yes ]
- sagittal and vertical cephalometric measurements [ Time Frame: before-after ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2007|
|Estimated Study Completion Date:||May 2009|
|Estimated Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Device: Seifi's Functional
Patient with Class II Division 1 and Deepbite malocclusion will wear the Seifi's Functional to get the benefit of skeletal and dentoalveolar correction.
Records will be obtained for each patient by the same operator before treatment and at the end of treatment. The appliance in this study is designed by Prof. Seifi and will be constructed by a well trained technician in the orthodontic laboratory of shahid Beheshti School of dentistry under the supervision of the operator. The appliance consists of a jack screw in the midpalatal region plus two Adams' clasps on the upper 1st molars and four Kimia clasps on the buccal embrasure of the upper deciduous molars or premolars. For the mandibular portion there is an incisal clasp and incisors are capped by acrylic.
The participants will be advised to use the appliance 24 hours per day except for meal times and when brushing the teeth or reading Farsi or English in class room.
Each patient will pay his/her first recall visit to the orthodontic department one week after the appliance delivery and will be instructed to turn the maxillary expansion jack screw 1:4 turn twice a week to achieve coordination of the upper and lower arches in the transverse dimension. The patients will be evaluated over one month intervals and necessary adjustments were made.
All cephalometric records, before and after treatment, will be coded and analyzed by a second party and the ultimate results and evaluations will be made.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688233
|Iran, Islamic Republic of|
|Dental School, Shahid Beheshti Medical Sciences University|
|Tehran, Iran, Islamic Republic of|
|Study Chair:||Massoud Seifi, DDS, MSD||Shahid Beheshti Medical Sciences University|