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

May 28, 2008 updated by: Shahid Beheshti University of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Dental School, Shahid Beheshti Medical Sciences University
        • Contact:
          • Nafiseh Memar Kermani, DDS
          • Phone Number: 98-21-2240-3010
        • Principal Investigator:
          • Massoud Seifi, DDS, MSD
        • Principal Investigator:
          • Majid Bargrizan, DDS, MSD
        • Principal Investigator:
          • Nafiseh Memar Kermani, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: F-seifi
Device: 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.
Other Names:
  • Functional Therapy
  • Class II correction
  • Deepbite correction

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Study Chair: Massoud Seifi, DDS, MSD, Shahid Beheshti Medical Sciences University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

October 1, 2008

Study Completion (Anticipated)

May 1, 2009

Study Registration Dates

First Submitted

May 23, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (Estimate)

June 2, 2008

Study Record Updates

Last Update Posted (Estimate)

June 2, 2008

Last Update Submitted That Met QC Criteria

May 28, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 234567

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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