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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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00688233
Acronym
Seifi-Fx
Enrollment
20
Registered
2008-06-02
Start date
2007-12-31
Completion date
2009-05-31
Last updated
2008-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DEVICESeifi'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.

Sponsors

Shahid Beheshti University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Overjet and Overbite2-6 month depending on the amount of OJ and OB and the patient compliances

Secondary

MeasureTime frame
sagittal and vertical cephalometric measurementsbefore-after

Countries

Iran

Contacts

Primary ContactMassoud Seifi, DDS,MSD
seifimassoud@gmail.com98-21-2204-3343

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026