Effect of Changing the Activation Frequency of the Arch W... | NCT04106141

Studies
Effect of Changing the Activation Frequency of the Arch Wires on the Rate of Leveling and Alignment in Moderate Crowding Cases

NCT04106141

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Sep 26, 2019Actual

Enrollment

22Estimated

Phase

Not Applicable

Conditions

Leveling and Alignment of Teeth

Interventions

6 weeks changing of archwire
4 weeks changing of 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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Estimated

Primary Completion Date

Sep 4, 2021Estimated

Completion Date

Nov 9, 2021Estimated

First Submitted Date

Sep 23, 2019

First Submission Date that Met QC Criteria

Sep 25, 2019

First Posted Date

Sep 26, 2019Actual

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

Sep 25, 2019

Last Update Posted Date

Sep 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Leveling and alignment is the first stage in the orthodontic treatment, performed for every patient .The archwire are usually changed every 4 weeks for reactivation of the force on the teeth. However, this means that large number of appointments and archwires are required. On the other hand, there is a lack of evidence that less number of appointments with longer time intervals between the visits and less number of wires will give the same effect.

Detailed Description

Not provided

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

22Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	Other		Other: 4 weeks changing of archwire
intervention group	Active Comparator		Other: 6 weeks changing of archwire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
6 weeks changing of archwire	Other	changing the archwire after 6 weeks instead of 4 weeks	intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Degree of alignment of teeth	the teeth are aligned together by using Little irregularity index to measure the decrease in the discrepency in each digital model taken after changing of the wire	5 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients aged (18~33)
CVMI = 6
Moderate crowding (4-8) as described by Laura mitchel
No extractions required

Exclusion Criteria:

Growing patients
Previous orthodontic treatment
Missing teeth other than the wisdoms

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

33 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided