Clinical trial NCT02190630: Study to Measure the Effect of Part Time Versus Full Time Orthodontic Appliance Wear
Official title: A Prospective Randomised Controlled Trial Investigating the Skeletal and Dental Effects of a Removable Brace That Works on the Upper and Lower Teeth at the Same Time Worn Part Time Versus Full Time
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class II Division 1 Malocclusion
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: National Health Service, United Kingdom
First posted: 2014-07-15
Enrollment: 62
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Exclusion Criteria:

* No previous orthodontic treatment
* No relevant medical history or craniofacial syndrome

Primary outcomes:
measure: remaining overjet measured with an orthodontic ruler
timeFrame: outcome measure will be assessed after 12 months appliance wear and after a 3 month relapse period
measure: Cephalometric Changes
timeFrame: Outcome will be assessed after 12m of appliance wear and after 3 months of settling.
Secondary outcomes:
measure: Comparison of subjective and objective measures of appliance wear
timeFrame: 12 months of appliance wear
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Dental Insitiute Royal London Hospital
Study officials:
affiliation: Queen Mary University of London
name: Kate Counihan, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Mary University of London
name: Jeet Parekh, BDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parekh J, Counihan K, Fleming PS, Pandis N, Sharma PK. Effectiveness of part-time vs full-time wear protocols of Twin-block appliance on dental and skeletal changes: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2019 Feb;155(2):165-172. doi: 10.1016/j.ajodo.2018.07.016.