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

NCT02190630 | Unknown DMC

• 1 other identifier: ReDA Ref: 009038
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Class II Division 1 Malocclusion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Comparison of subjective and objective measures of appliance wear

  12 months of appliance wear

Study Arms (2)

Part time (12hour) wear

ACTIVE COMPARATOR

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

Device: Modified Clark Twin Block

Full time (24hour) wear

ACTIVE COMPARATOR

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

Device: Modified Clark Twin Block

Interventions

Modified Clark Twin Block 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

Also known as: Clark Twin Block, Twin Block, Functional Appliance

Full time (24hour) wear; Part time (12hour) wear

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Queen Mary University of London: lead
• National Health Service, United Kingdom: collaborator

Study Sites (1)

Dental Insitiute Royal London Hospital

London, London, E1 1BB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30712687 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Kate Counihan, BDS

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

• Jeet Parekh, BDS

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: July 15, 2014
• Study Start: December 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 4, 2017

Record last verified: 2016-09

Locations

GB (1)