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

NCT ID: NCT00688233

Last Updated: 2008-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-05-31

Brief Summary

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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

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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.

Conditions

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Orthodontic Appliance Design Retrognathism Malocclusion, Angle Class II Deepbite

Keywords

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Seifi's Functional, Class II/1, Mandibular Retrognathism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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F-seifi

Group Type EXPERIMENTAL

Seifi's Functional

Intervention Type DEVICE

Patient with Class II Division 1 and Deepbite malocclusion will wear the Seifi's Functional to get the benefit of skeletal and dentoalveolar correction.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Functional Therapy Class II correction Deepbite correction

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Shahid Beheshti Medical University

Principal Investigators

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Massoud Seifi, DDS, MSD

Role: STUDY_CHAIR

Shahid Beheshti Medical Sciences University

Locations

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Dental School, Shahid Beheshti Medical Sciences University

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Massoud Seifi, DDS,MSD

Role: CONTACT

Phone: 98-21-2204-3343

Email: [email protected]

Facility Contacts

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Nafiseh Memar Kermani, DDS

Role: primary

Other Identifiers

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234567

Identifier Type: -

Identifier Source: org_study_id