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

Study Overview
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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.

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

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

Intervention / Treatment
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* Device: Seifi's Functional


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F-seifi<br> | Device: Seifi's Functional<br>* Patient with Class II Division 1 and Deepbite malocclusion will wear the Seifi's Functional to get the benefit of skeletal and dentoalveolar correction.<br>* Other names: Deepbite correction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overjet and Overbite |  | 2-6 month depending on the amount of OJ and OB and the patient compliances | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sagittal and vertical cephalometric measurements |  | before-after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seifi's Functional, Class II/1, Mandibular Retrognathism