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Effect of the Innovated Seifi's Functional Appliance on Skeletal and Dentoalveolar Changes of Class II/ 1, Deep Bite (Seifi-Fx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Shahid Beheshti University of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Orthodontic Appliance Design Retrognathism Malocclusion, Angle Class II Deepbite Device: Seifi's Functional Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2007
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: F-seifi 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.
Other Names:
  • Functional Therapy
  • Class II correction
  • Deepbite correction

Primary Outcome Measures :
  1. Overjet and Overbite [ Time Frame: 2-6 month depending on the amount of OJ and OB and the patient compliances ]

Secondary Outcome Measures :
  1. sagittal and vertical cephalometric measurements [ Time Frame: before-after ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age between 8 - 12 years old
  • Class Π division 1 malocclusion (ANB>4)
  • Increased over jet (>4mm)
  • Increased overbite (>4mm)

Exclusion Criteria:

  • History of previous orthodontic treatment
  • Evidence of craniofacial syndromes

Information from the National Library of Medicine

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 identifier (NCT number): NCT00688233

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Contact: Massoud Seifi, DDS,MSD 98-21-2204-3343

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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         
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
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Study Chair: Massoud Seifi, DDS, MSD Shahid Beheshti Medical Sciences University

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Responsible Party: Professor Massoud Seifi, Shahid Beheshti Medical University Identifier: NCT00688233    
Other Study ID Numbers: 234567
First Posted: June 2, 2008    Key Record Dates
Last Update Posted: June 2, 2008
Last Verified: May 2008
Keywords provided by Shahid Beheshti University of Medical Sciences:
Seifi's Functional, Class II/1, Mandibular Retrognathism
Additional relevant MeSH terms:
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Malocclusion, Angle Class II
Tooth Diseases
Stomatognathic Diseases
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Mandibular Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities