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

Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT00688233
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
17
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
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 :
Dec 1, 2007
Anticipated Primary Completion Date :
Oct 1, 2008
Anticipated Study Completion Date :
May 1, 2009

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overjet and Overbite [2-6 month depending on the amount of OJ and OB and the patient compliances]

    Secondary Outcome Measures

    1. sagittal and vertical cephalometric measurements [before-after]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 12 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dental School, Shahid Beheshti Medical Sciences University Tehran Iran, Islamic Republic of

    Sponsors and Collaborators

    • Shahid Beheshti University of Medical Sciences

    Investigators

    • Study Chair: Massoud Seifi, DDS, MSD, Shahid Beheshti Medical Sciences University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00688233
    Other Study ID Numbers:
    • 234567
    First Posted:
    Jun 2, 2008
    Last Update Posted:
    Jun 2, 2008
    Last Verified:
    May 1, 2008
    Keywords provided by , ,
    Seifi's Functional, Class II/1, Mandibular Retrognathism
    Additional relevant MeSH terms:
    Retrognathia
    Malocclusion
    Malocclusion, Angle Class II
    Overbite

    Study Results

    No Results Posted as of Jun 2, 2008