NCT02427282

Brief Summary

This study aimed to compare the effectiveness and efficiency of miniscrew-supported and standard frog molar distalizing appliances.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2012

Typical duration for phase_1

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

July 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
Last Updated

May 4, 2015

Status Verified

April 1, 2015

Enrollment Period

2.4 years

First QC Date

April 19, 2015

Last Update Submit

April 30, 2015

Conditions

Distalization by Miniscrews

Outcome Measures

Primary Outcomes (1)

  • mesial migration of anterior teeth measured in millimeter and angles by using cone beam computerized tomography

    pretreatment and postdistalization records as cone beam computerized tomography and cast analysis

    6months

Study Arms (2)

MS. Frog

ACTIVE COMPARATOR

miniscrew-supported frog molar distalizing appliance

Device: miniscrew-supported Frog molar distalizing appliance

Stand. Frog

EXPERIMENTAL

Standard Frog appliance

Device: Standard Frog molar distalizing appliance

Interventions

miniscrew-supported Frog molar distalizing applianceDEVICE

miniscrew 10mm length and 1.7mm diameter FORESTADENT company

Also known as: Skeletal Frog
MS. Frog
Standard Frog molar distalizing applianceDEVICE

Nance buttons attached to first premolars band

Also known as: Conventional Frog
Stand. Frog

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All the subjects had an age range from 11 to 16 years with a mean of ±13.5 years.
  • All the subjects had skeletal Class 1 or mild skeletal Class 2 due to maxillary excess.
  • All the subjects had bilateral Class II molar relationship.
  • All subjects were free from any dental anomalies.
  • All subjects had good oral hygiene.

You may not qualify if:

  • Missing permanent teeth with exception of 3rd molar.
  • Previous orthodontic treatment.
  • Systemic disease that may influence orthodontic treatment and drug intake.
  • Periodontal disease.
  • Functional mandibular deviations and facial asymmetry.
  • History of parafunctional habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate, orthodontic department

Study Record Dates

First Submitted

April 19, 2015

First Posted

April 28, 2015

Study Start

July 1, 2012

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

May 4, 2015

Record last verified: 2015-04