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

Primary Purpose

Orthodontic Appliance Design, Retrognathism, Malocclusion, Angle Class II

Status

Unknown status

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Seifi's Functional

About this trial

This is an interventional treatment trial for Orthodontic Appliance Design focused on measuring Seifi's Functional, Class II/1, Mandibular Retrognathism

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Dental School, Shahid Beheshti Medical Sciences UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

F-seifi

Arm Description

Outcomes

Primary Outcome Measures

Overjet and Overbite

Secondary Outcome Measures

sagittal and vertical cephalometric measurements

Full Information

NCT ID

NCT00688233

First Posted

May 23, 2008

Last Updated

May 28, 2008

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00688233

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Unknown status

Study Start Date

December 2007 (undefined)

Primary Completion Date

October 2008 (Anticipated)

Study Completion Date

May 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

F-seifi

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Seifi's Functional

Other Intervention Name(s)

Functional Therapy, Class II correction, Deepbite correction

Intervention Description

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

Primary Outcome Measure Information:

Title

Overjet and Overbite

Time Frame

2-6 month depending on the amount of OJ and OB and the patient compliances

Secondary Outcome Measure Information:

Title

sagittal and vertical cephalometric measurements

Time Frame

before-after

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Massoud Seifi, DDS,MSD

Phone

98-21-2204-3343

seifimassoud@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Massoud Seifi, DDS, MSD

Organizational Affiliation

Shahid Beheshti Medical Sciences University

Official's Role

Study Chair

Facility Information:

Facility Name

Dental School, Shahid Beheshti Medical Sciences University

City

Tehran

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nafiseh Memar Kermani, DDS

Phone

98-21-2240-3010

First Name & Middle Initial & Last Name & Degree

Massoud Seifi, DDS, MSD

First Name & Middle Initial & Last Name & Degree

Majid Bargrizan, DDS, MSD

First Name & Middle Initial & Last Name & Degree

Nafiseh Memar Kermani, DDS

12. IPD Sharing Statement

Learn more about this trial

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

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