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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)
This study is currently recruiting participants.
Study NCT00688233   Information provided by Shaheed Beheshti Medical University
First Received: May 23, 2008   Last Updated: May 28, 2008   History of Changes

May 23, 2008
May 28, 2008
December 2007
October 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00688233 on ClinicalTrials.gov Archive Site
sagittal and vertical cephalometric measurements [ Time Frame: before-after ] [ Designated as safety issue: Yes ]
Same as current
 
Effect of the Innovated Seifi's Functional Appliance on Skeletal and Dentoalveolar Changes of Class II/ 1, Deep Bite
Phase 1 Effect of the Innovated Seifi's Functional Appliance on the Skeletal and Dentoalveolar Changes of Class II/Division 1, Deep Bite Cases

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.

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.

Phase I
Interventional
Treatment, Open Label, Single Group Assignment, Efficacy Study
  • Orthodontic Appliance Design
  • Retrognathism
  • Malocclusion, Angle Class II
  • Deepbite
Device: Seifi's Functional
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
20
May 2009
October 2008   (final data collection date for primary outcome measure)

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
Both
8 Years to 12 Years
Yes
Contact: Massoud Seifi, DDS,MSD 98-21-2204-3343 seifimassoud@gmail.com
Iran, Islamic Republic of
 
NCT00688233
Professor Massoud Seifi, Shahid Beheshti Medical University
234567
Shaheed Beheshti Medical University
 
Study Chair: Massoud Seifi, DDS, MSD Shahid Beheshti Medical Sciences University
Shaheed Beheshti Medical University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP