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

Malocclusion, Angle Class II Clinical Trial

— Seifi-Fx  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00688233
• Other study ID #: 234567
• Status: Recruiting
• Phase: Phase 1
• First received: May 23, 2008
• Last updated: May 28, 2008
• Start date: December 2007
• Est. completion date: May 2009

Study information

• Verified date: May 2008
• Source: hahid Beheshti University of Medical Sciences
• Contact: Massoud Seifi, DDS,MSD
• Phone: 98-21-2204-3343
• Email: seifimassoud[@]gmail.com
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deepbite
• Malocclusion
• Malocclusion, Angle Class II
• Orthodontic Appliance Design
• Retrognathia
• Retrognathism

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Dental School, Shahid Beheshti Medical Sciences University	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overjet and Overbite		2-6 month depending on the amount of OJ and OB and the patient compliances	Yes
Secondary	sagittal and vertical cephalometric measurements		before-after	Yes