Orthodontic Archwire Effectiveness Trial | NCT02659813

Studies
Orthodontic Archwire Effectiveness Trial

NCT02659813

Sponsor

University of Dundee

Status

Completed

Last Update Posted

Oct 18, 2021Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Malocclusion

Interventions

Orthodontic archwire

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

Apr 2019Actual

Completion Date

Aug 17, 2021Actual

First Submitted Date

Jan 14, 2016

First Submission Date that Met QC Criteria

Jan 19, 2016

First Posted Date

Jan 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2021

Last Update Posted Date

Oct 18, 2021Actual

Name	Class
Ormco Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study protocol is for a randomised clinical trial which aims to test two materials used as orthodontic archwire to compare FireWire archwires to Copper Nickel Titanium (CNiTi) archwires. Both professional and patient related outcome measures are to be used to fully evaluate performance.

Detailed Description

This is a randomised clinical trial of Firewire and CNiTi as orthodontic aligning archwires. A two group single blind parallel multicentre study design in a National Health Service primary care setting in England will be used.

Patients will be recruited from those attending the practices for orthodontic treatment that meet the inclusion and exclusion criteria. Online randomisation will allocate to one of the two groups, stratified by centre and age group (adolescent / adult).

Sample size calculation indicates a total sample size of 42, but allowing for dropouts and missing data the investigators will recruit 64, 32 to each group.

Patients will be treated according to a strict clinical protocol including customised Damon Q fixed appliances and defined archwire sequence. Participants will be seen at initial 5 week intervals for data collection after new archwire placement, and otherwise at routine 10 week intervals.

Primary outcome data (rate of alignment) will be collected over the initial 10 weeks and secondary outcomes over the duration of the treatment (18 months approx).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Firewire	Experimental	Experimental Group 1. Novel orthodontic archwire.	Device: Orthodontic archwire
CNiTi	Experimental	Experimental Group 2. Current best available orthodontic archwire	Device: Orthodontic archwire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Orthodontic archwire	Device	Archwire used to align teeth in an orthodontic fixed brace	CNiTi Firewire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of tooth movement	Rate teeth move in response to force from archwire measured in millimetres on digital dental models	Initial six months of treatment

Secondary Outcomes

Measure	Description	Time Frame
Pain assessed by Visual Analogue Scale	Visual Analogue Scale pain score after archwire placed	Initial six months of treatment
Tooth Root Resorption assessed on panoramic radiograph using method of Pandis et al (2008)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

12 years of age or older
Class 1 Incisor relationship (British Standards Institute Classification)
Labial segment crowding in upper and / or lower arch >4mm
Little's Irregularity Index in upper and / or lower arch >4mm
Eligible for NHS orthodontic treatment
Planned non-extraction upper and lower fixed appliance orthodontic treatment

Exclusion Criteria:

Previous fixed appliance orthodontic treatment
Previous functional appliance treatment
Planned use of fixed auxiliary appliances (e.g. quadhelix, Trans Palatal Arch)
Cleft lip and palate or other craniofacial anomalies
Hypodontia (excluding third molars), or missing teeth due to previous extraction
Abnormal root morphology on pre-treatment radiographs
Confirmed history of nickel allergy
A medical history resulting in them taking analgesics for a chronic condition
Limited mouth opening or other contra-indication to intra-oral scanning

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
David R Bearn, BDS, PhD	University of Dundee	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18984396	Background	Pandis N, Nasika M, Polychronopoulou A, Eliades T. External apical root resorption in patients treated with conventional and self-ligating brackets. Am J Orthod Dentofacial Orthop. 2008 Nov;134(5):646-51. doi: 10.1016/j.ajodo.2007.01.032.

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases