Effect of the Innovated Seifi's Functional Appliance on Skeletal and Dentoalveolar Changes of Class II/ 1, Deep Bite (Seifi-Fx)
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|ClinicalTrials.gov Identifier: NCT00688233|
Recruitment Status : Unknown
Verified May 2008 by Shahid Beheshti University of Medical Sciences.
Recruitment status was: Recruiting
First Posted : June 2, 2008
Last Update Posted : June 2, 2008
|Condition or disease||Intervention/treatment||Phase|
|Orthodontic Appliance Design Retrognathism Malocclusion, Angle Class II Deepbite||Device: Seifi's Functional||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2007|
|Estimated Primary Completion Date :||October 2008|
|Estimated Study Completion Date :||May 2009|
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.
- Overjet and Overbite [ Time Frame: 2-6 month depending on the amount of OJ and OB and the patient compliances ]
- sagittal and vertical cephalometric measurements [ Time Frame: before-after ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688233
|Contact: Massoud Seifi, DDS,MSDfirstname.lastname@example.org|
|Iran, Islamic Republic of|
|Dental School, Shahid Beheshti Medical Sciences University||Recruiting|
|Tehran, Iran, Islamic Republic of|
|Contact: Nafiseh Memar Kermani, DDS 98-21-2240-3010|
|Principal Investigator: Massoud Seifi, DDS, MSD|
|Principal Investigator: Majid Bargrizan, DDS, MSD|
|Principal Investigator: Nafiseh Memar Kermani, DDS|
|Study Chair:||Massoud Seifi, DDS, MSD||Shahid Beheshti Medical Sciences University|