Study to Measure the Effect of Part Time Versus Full Time Orthodontic Appliance Wear

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-07-31

Brief Summary

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The aim of this study is to assess skeletal (bone) and dental (teeth) changes occurring following wear of a twin block functional appliance (removable brace which postures the lower jaw forward to improve a discrepancy between the upper and lower jaw) for differing time periods.

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Detailed Description

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Functional appliances are ordinarily worn full time in adolescence between 11 and 14 years with a discrepancy between their upper and lower jaws. The reason it is worn between these ages is to avail of the pre pubertal growth spurt, evidence for full time wear is merely empirical.If this appliance only had to be worn part time it would have a significant change in orthodontics in terms of patient acceptance and compliance.The investigators plan on recruiting 84 patients to the study and these subjects will be referred from hospital colleagues. The investigators will randomly allocate the subjects into 2 groups, Group 1 will wear the appliance Full Time(24hours), group 2 will wear the appliance part time(12hours).

The study will be conducted in the Dental Institute at the Royal London Hospital, this hospital setting will be the sole site.

The study will last for 15 months from the time the last patient is recruited. Participants will undergo an initial records appointment where a radiograph and clinical measurements will be taken followed by 12 months of functional appliance treatment where the patient will be reviewed at 6-8weekly intervals and clinical measurements taken.A final radiograph will be taken at 15months.

Conditions

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Class II Division 1 Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Part time (12hour) wear

the' Modified Clark Twin Block' will be worn part time

Group Type ACTIVE_COMPARATOR

Modified Clark Twin Block

Intervention Type DEVICE

The Modified Clark Twin Block is a type of functional orthodontic appliance used to posture the lower jaw forward to treat discrepancies between the upper and lower jaw bones

Full time (24hour) wear

the ' Modified Clark Twin Block' will be worn full time

Group Type ACTIVE_COMPARATOR

Modified Clark Twin Block

Intervention Type DEVICE

The Modified Clark Twin Block is a type of functional orthodontic appliance used to posture the lower jaw forward to treat discrepancies between the upper and lower jaw bones

Interventions

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Modified Clark Twin Block

The Modified Clark Twin Block is a type of functional orthodontic appliance used to posture the lower jaw forward to treat discrepancies between the upper and lower jaw bones

Intervention Type DEVICE

Other Intervention Names

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Clark Twin Block Twin Block Functional Appliance

Eligibility Criteria

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Inclusion Criteria

* Class II div 1 malocclusion(upper front teeth lying more forward than lower front teeth with upper front teeth proclined),
* Overjet(horizontal difference between upper and lower front teeth) measuring minimum of 7mm,
* Male subjects 12--14 years at the start of treatment,
* Female subjects 11--13 years at start of treatment,
* Willingness of the patient and parent to participate in the study.