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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 recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Shaheed Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00688233
First received: May 23, 2008
Last updated: May 28, 2008
Last verified: May 2008
History of Changes
  Purpose

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 Intervention Phase
Orthodontic Appliance Design
Retrognathism
Malocclusion, Angle Class II
Deepbite
 Device: Seifi's Functional
 Phase 1

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • sagittal and vertical cephalometric measurements [ Time Frame: before-after ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688233

Contacts
Contact: Massoud Seifi, DDS,MSD 98-21-2204-3343 seifimassoud@gmail.com

Locations
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
Shaheed Beheshti Medical University
Investigators
Study Chair: Massoud Seifi, DDS, MSD Shahid Beheshti Medical Sciences University
  More Information

No publications provided

Responsible Party: Professor Massoud Seifi, Shahid Beheshti Medical University
ClinicalTrials.gov Identifier: NCT00688233     History of Changes
Other Study ID Numbers: 234567
Study First Received: May 23, 2008
Last Updated: May 28, 2008
Health Authority: Iran: Ministry of Health

Keywords provided by Shaheed Beheshti Medical University:
Seifi's Functional, Class II/1, Mandibular Retrognathism

Additional relevant MeSH terms:
Malocclusion
Malocclusion, Angle Class II
Retrognathism
Overbite
Tooth Diseases
Stomatognathic Diseases
Jaw Abnormalities
Jaw Diseases
 Musculoskeletal Diseases
Mandibular Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 22, 2013