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OpenTrials
Completed

NCT Number: NCT05155774

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

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.

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Key information

Conditions

Compliance, Patient Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence Treatment Adherence and Compliance

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Postgraduate Dentaln Education, department of orthodontics

Jönköping, Jönköping City Council, 55453, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Twin Block

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Region Jönköping County

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 14, 2021
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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