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

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

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.

Study Overview

• Status: Unknown
• Conditions: Class II Division 1 Malocclusion
• Intervention / Treatment: Device: Modified Clark Twin Block

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E1 1BB
    • Dental Insitiute Royal London Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Part time (12hour) wear; the' Modified Clark Twin Block' will be worn part time	Device: 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; Other Names: Twin Block; Clark Twin Block; Functional Appliance
ACTIVE_COMPARATOR: Full time (24hour) wear; the ' Modified Clark Twin Block' will be worn full time	Device: 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; Other Names: Twin Block; Clark Twin Block; Functional Appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
remaining overjet measured with an orthodontic ruler	the initial overjet will compared to the final overjet following 12 months of appliance treatment, and 3 months of relapse. overjet will be measured with an orthodontic ruler at every review appointment	outcome measure will be assessed after 12 months appliance wear and after a 3 month relapse period
Cephalometric Changes	Both linear and angular cephalometric changes will be assessed over this timeframe.	Outcome will be assessed after 12m of appliance wear and after 3 months of settling.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of subjective and objective measures of appliance wear	Subjective (patient completed time charts) and objective (theramon micro-sensor) measures of wear will be assessed over 12months of appliance wear.	12 months of appliance wear

Collaborators and Investigators

• Sponsor: Queen Mary University of London
• Collaborators: National Health Service, United Kingdom
• Investigators: Principal Investigator: Kate Counihan, BDS, Queen Mary University of London; Principal Investigator: Jeet Parekh, BDS, Queen Mary University of London

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ANTICIPATED): July 1, 2017
• Study Completion (ANTICIPATED): July 1, 2017

Study Registration Dates

• First Submitted: March 12, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (ESTIMATE): July 15, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 3, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: ReDA Ref: 009038