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Trial NCT00688233

Resource URI: http://static.linkedct.org/resource/trials/NCT00688233
linkedct:acronym Seifi-Fx
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/45387>
linkedct:brief_title Effect of the Innovated Seifi's Functional Appliance on Skeletal and Dentoalveolar Changes of Class II/ 1, Deep Bite
linkedct:condition <http://static.linkedct.org/resource/condition/11584>
linkedct:condition <http://static.linkedct.org/resource/condition/3618>
linkedct:condition <http://static.linkedct.org/resource/condition/7767>
linkedct:condition <http://static.linkedct.org/resource/condition/9329>
linkedct:criteria Inclusion Criteria: - Age between 8 - 12 years old - Class  division 1 malocclusion (ANB>4) - Increased over jet (>4mm) - Increased overbite (>4mm) Exclusion Criteria: - History of previous orthodontic treatment - Evidence of craniofacial syndromes
linkedct:description 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers Accepts Healthy Volunteers
linkedct:eligibility_maximum_age 12 Years
linkedct:eligibility_minimum_age 8 Years
linkedct:end_date May 2009
linkedct:enrollment 20 (xsd:int)
linkedct:firstreceived_date May 23, 2008
linkedct:id NCT00688233
linkedct:intervention <http://static.linkedct.org/resource/intervention/46540>
rdfs:label Trial NCT00688233
linkedct:lastchanged_date May 28, 2008
linkedct:lead_sponsor_agency Shaheed Beheshti Medical University
linkedct:location <http://static.linkedct.org/resource/location/72997>
linkedct:nct_id NCT00688233
linkedct:number_of_arms 1 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct: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
linkedct:org_study_id 234567
linkedct:overall_contact_email seifimassoud@gmail.com
linkedct:overall_contact_last_name Massoud Seifi, DDS,MSD
linkedct:overall_contact_phone 98-21-2204-3343
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/39407>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/1388>
foaf:page <http://clinicaltrials.gov/show/NCT00688233>
linkedct:phase Phase 1
linkedct:primary_completion_date October 2008
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/36774>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/98933>
linkedct:source Shaheed Beheshti Medical University
linkedct:start_date December 2007
linkedct:study_design Treatment, Open Label, Single Group Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary For improving the appearance of protruded upper front teeth when lower front teeth may touch palatal mucosa or have proximity to that; the innovated Seifi's Functional Appliance may be used.
rdf:type linkedct:trials
linkedct:verification_date May 2008