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

Treatment Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05155774
• Other study ID #: EPM 2017/382-31
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: October 22, 2020

Study information

• Verified date: November 2021
• Source: Region Jönköping County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: October 22, 2020
• Est. primary completion date: October 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Compliance, Patient
• Malocclusion
• Malocclusion, Angle Class II
• Treatment Adherence

Intervention

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

Locations

Country	Name	City	State
Sweden	Institute of Postgraduate Dentaln Education, department of orthodontics	Jönköping	Jönköping City Council

Sponsors (1)

Lead Sponsor	Collaborator
Region Jönköping County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wear time of the Twin Block appliance, compared between participants randomized into two groups with different check up intervals	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	Change in overjet, compared between participants randomized into two groups with different check up intervals	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.
Secondary	Change in overbite, compared between participants randomized into two groups with different check up intervals	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.
Secondary	Change in molar relationship, compared between participants randomized into two groups with different check up intervals	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.