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

Primary Purpose

Class II Division 1 Malocclusion

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Modified Clark Twin Block
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Class II Division 1 Malocclusion

Eligibility Criteria

11 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dental Insitiute Royal London Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Part time (12hour) wear

Full time (24hour) wear

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Cephalometric Changes
Both linear and angular cephalometric changes will be assessed over this timeframe.

Secondary Outcome Measures

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.

Full Information

First Posted
March 12, 2014
Last Updated
January 3, 2017
Sponsor
Queen Mary University of London
Collaborators
National Health Service, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT02190630
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London
Collaborators
National Health Service, United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part time (12hour) wear
Arm Type
Active Comparator
Arm Description
the' Modified Clark Twin Block' will be worn part time
Arm Title
Full time (24hour) wear
Arm Type
Active Comparator
Arm Description
the ' Modified Clark Twin Block' will be worn full time
Intervention Type
Device
Intervention Name(s)
Modified Clark Twin Block
Other Intervention Name(s)
Clark Twin Block, Twin Block, Functional Appliance
Intervention Description
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
Primary Outcome Measure Information:
Title
remaining overjet measured with an orthodontic ruler
Description
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
Time Frame
outcome measure will be assessed after 12 months appliance wear and after a 3 month relapse period
Title
Cephalometric Changes
Description
Both linear and angular cephalometric changes will be assessed over this timeframe.
Time Frame
Outcome will be assessed after 12m of appliance wear and after 3 months of settling.
Secondary Outcome Measure Information:
Title
Comparison of subjective and objective measures of appliance wear
Description
Subjective (patient completed time charts) and objective (theramon micro-sensor) measures of wear will be assessed over 12months of appliance wear.
Time Frame
12 months of appliance wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Counihan, BDS
Organizational Affiliation
Queen Mary University of London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeet Parekh, BDS
Organizational Affiliation
Queen Mary University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dental Insitiute Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30712687
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.
Results Reference
derived

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

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