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

Phase 1

• Conditions: Orthodontic Appliance Design; Retrognathism; Malocclusion, Angle Class II; Deepbite
• Interventions: Device: Seifi's Functional

• Registration Number: NCT00688233
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-12
• Status Verified: 2008-05
• Study First Submitted: 2008-05-23
• Study First Submitted QC: 2008-05-28
• Last Update Submitted: 2008-05-28
• Study First Posted: 2008-06-02
• Last Update Posted: 2008-06-02
• Primary Completion: 2008-10
• Study Completion: 2009-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
F-seifi	Seifi's Functional	-

Primary Outcome Measures

Name	Time	Method
Overjet and Overbite	2-6 month depending on the amount of OJ and OB and the patient compliances

Secondary Outcome Measures

Name	Time	Method
sagittal and vertical cephalometric measurements	before-after

Trial Locations

Locations (1)

Dental School, Shahid Beheshti Medical Sciences University; 🇮🇷 Tehran, Iran, Islamic Republic of