NCT00688233

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 2, 2008

Status Verified

May 1, 2008

Enrollment Period

10 months

First QC Date

May 23, 2008

Last Update Submit

May 28, 2008

Conditions

Orthodontic Appliance DesignRetrognathismMalocclusion, Angle Class IIDeepbite

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Overjet and Overbite

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

Secondary Outcomes (1)

  • sagittal and vertical cephalometric measurements

    before-after

Study Arms (1)

F-seifi

EXPERIMENTAL
Device: Seifi's Functional

Interventions

Seifi's FunctionalDEVICE

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

Also known as: Functional Therapy, Class II correction, Deepbite correction
F-seifi

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age between 8 - 12 years old
  • Class Π division 1 malocclusion (ANB\>4)
  • Increased over jet (\>4mm)
  • Increased overbite (\>4mm)

You may not qualify if:

  • History of previous orthodontic treatment
  • Evidence of craniofacial syndromes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental School, Shahid Beheshti Medical Sciences University

Tehran, Tehran Province, Iran

RECRUITING

MeSH Terms

Conditions

RetrognathiaMalocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMandibular DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMalocclusionTooth Diseases

Study Officials

  • Massoud Seifi, DDS, MSD

    Shahid Beheshti Medical Sciences University

    STUDY CHAIR

Central Study Contacts

Massoud Seifi, DDS,MSD

CONTACT

98-21-2204-3343seifimassoud@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 23, 2008

First Posted

June 2, 2008

Study Start

December 1, 2007

Primary Completion

October 1, 2008

Study Completion

May 1, 2009

Last Updated

June 2, 2008

Record last verified: 2008-05

Locations

IR(1)