NCT00248014

Brief Summary

This investigation aims at distinguishing the subjects that react in a favorable way to the treatment protocol we propose for the Class II treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

3.1 years

First QC Date

November 1, 2005

Last Update Submit

January 18, 2012

Conditions

CLASS II DIVISION 1 MALOCCLUSION

Keywords

CLASS IIFUNCTIONAL APPLIANCEMANDIBULAR ADVANCEMENT STABILITY

Outcome Measures

Primary Outcomes (1)

  • Achievement of Class I relationship

    18 months

Interventions

Mandibular Advancement Via A Functional ApplianceDEVICE

Functional appliance

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Class II Division 1 malocclusion
  • Crowding no more than 4 mm per side
  • Healthy subjects

You may not qualify if:

  • Hormonal imbalances
  • TMJ symptoms
  • Craniofacial abnormalities
  • Arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthodontic Clinic of Auth

Thessaloniki, Macedonia, 54124, Greece

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • EFFI BASDRA, PHD

    ASSISTANT PROFESSOR

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Ioanna Gidarakou

Study Record Dates

First Submitted

November 1, 2005

First Posted

November 3, 2005

Study Start

October 1, 2005

Primary Completion

November 1, 2008

Study Completion

April 1, 2009

Last Updated

January 19, 2012

Record last verified: 2012-01

Locations

GR(1)