Clinical trial NCT05155774: Treatment Adherence With Twin-Blocks for Correction of Class II Malocclusion
Official title: Treatment Adherence With Twin-Blocks for Correction of Class II Malocclusion - a Randomized Controlled Trial on Two Check-up Prescriptions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compliance, Patient
Treatment Adherence
Keywords: Orthodontic
Removable
Compliance
Adherence
Twin Block
Lead sponsor: Region Jönköping County
Sponsor class: OTHER_GOV
First posted: 2021-12-14
Enrollment: 73
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Wear time of the Twin Block appliance, compared between participants randomized into two groups with different check up intervals
timeFrame: From randomization to 12 months of treatment
Secondary outcomes:
measure: Change in overjet, compared between participants randomized into two groups with different check up intervals
timeFrame: From randomization to treatment completion, up to 24 months.
measure: Change in overbite, compared between participants randomized into two groups with different check up intervals
timeFrame: From randomization to treatment completion, up to 24 months.
measure: Change in molar relationship, compared between participants randomized into two groups with different check up intervals
timeFrame: From randomization to treatment completion, up to 24 months.
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: Institute of Postgraduate Dentaln Education, department of orthodontics
state: Jönköping City Council
Study officials:
affiliation: Institute of Postgraduate Dental Education, department of Orthodontics, Jönköping, Sweden
name: Anders Magnusson, DDS, DMSc
role: STUDY_CHAIR
affiliation: Orthodontic department, Faculty of odontology, Malmö University, Sweden
name: Mikael Sonesson, DDS, DMSc
role: STUDY_CHAIR
References:
citation: Frilund E, Sonesson M, Magnusson A. Patient compliance with Twin Block appliance during treatment of Class II malocclusion: a randomized controlled trial on two check-up prescriptions. Eur J Orthod. 2023 Mar 31;45(2):142-149. doi: 10.1093/ejo/cjac046.