Treatment Adherence With Twin-Blocks for Correction of Class II Malocclusion

December 20, 2021 updated by: Region Jönköping County

Treatment Adherence With Twin-Blocks for Correction of Class II Malocclusion - a Randomized Controlled Trial on Two Check-up Prescriptions

To compare the effect of two control intervals (once every 4th week or once every 6th week) on the wear time of a Twin Block removable appliance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

If the patient fulfill the inclusion criteria, they will be asked to participate in the study. After being informed about the study and the planned treatment, participants and their guardians will give their written consent to participate in the study.

Therafter they will be consecutively randomized into one of two groups with different control intervals, Group 1 (every 4th week) and Group 2 (every 6th week). They will recieve a clinical and radiological examination and then start treatment with a Twin Block appliance.

The Twin Block appliance will be fitted with a digital timer module to measure the wear time of the appliance objectively.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

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

  • Sweden
    • Jönköping City Council
      • Jönköping, Jönköping City Council, Sweden, 55453
        • Institute of Postgraduate Dentaln Education, department of orthodontics

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 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy patients (ASA 1 and 2)
  • Overjet of 6 mm or more
  • Incomplete lip closure

Exclusion Criteria:

  • Severe chronic conditions such as asthma or allergies
  • Neuroopsychiatric disorders
  • Craniofacial syndromes
  • Previous orthodontic treatment

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group, controlled every 6th week
This group was controlled every 6th week, in accordance with what is deemed to be "golden standard" for treatment with a Twin Block orthodontic appliance.
Device: Twin block
Twin Block orthodontic appliance for treating patients with Angle class II molar relationship and a large horizontal overjet, often in combination with an incomplete lip closure
Experimental: Test group, controlled every 4th week
This group was controlled every 4th week, testing if a more frequent control interval would increase compliance with a Twin block orthodontic appliance.
Device: Twin block
Twin Block orthodontic appliance for treating patients with Angle class II molar relationship and a large horizontal overjet, often in combination with an incomplete lip closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wear time of the Twin Block appliance, compared between participants randomized into two groups with different check up intervals
Time Frame: From randomization to 12 months of treatment
To measure if the wear time of the Twin Block appliance would increase if the control interval increased from once every 6th week to once every 4th week. The wear time was registered using the TheraMon system, and was measured in hours per day.
From randomization to 12 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in overjet, compared between participants randomized into two groups with different check up intervals
Time Frame: From randomization to treatment completion, up to 24 months.
To see if change in overjet would differ between or within the groups before and after treatment was finished. Horizontal overjet was measured in millimetres on study casts before and after treatment was finished.
From randomization to treatment completion, up to 24 months.
Change in overbite, compared between participants randomized into two groups with different check up intervals
Time Frame: From randomization to treatment completion, up to 24 months.
To see if change in overbite would differ between or within the groups before and after treatment. Overbite was measured in millimetres on study casts taken before and after treatment.
From randomization to treatment completion, up to 24 months.
Change in molar relationship, compared between participants randomized into two groups with different check up intervals
Time Frame: From randomization to treatment completion, up to 24 months.
To see how molar relationship would be differ between or within the two groups before and after treatment, measured in Angle classification on study casts before and after treatment completion.
From randomization to treatment completion, up to 24 months.

Collaborators and Investigators

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

Sponsor

Region Jönköping County

Investigators

  • Study Chair: Anders Magnusson, DDS, DMSc, Institute of Postgraduate Dental Education, department of Orthodontics, Jönköping, Sweden
  • Study Chair: Mikael Sonesson, DDS, DMSc, Orthodontic department, Faculty of odontology, Malmö University, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 1, 2018

Primary Completion (Actual)

October 22, 2020

Study Completion (Actual)

October 22, 2020

Study Registration Dates

First Submitted

November 2, 2021

First Submitted That Met QC Criteria

November 30, 2021

First Posted (Actual)

December 14, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPM 2017/382-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Depends on data security in europe and if the data can be securely shared in accordance with GDPR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Treatment Adherence

Clinical Trials on Twin block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe