Chairside Time and Bond Failure of Non Custom Versus Cust... | NCT03365232

Studies
Chairside Time and Bond Failure of Non Custom Versus Custom Base Orthodontic Attachments During Indirect Bonding

NCT03365232

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Dec 7, 2017Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Orthodontic Appliance Complication

Interventions

non custom base attachment
custom base attachment

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

Dec 2017

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 2018Estimated

Primary Completion Date

Jan 2019Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Nov 25, 2017

First Submission Date that Met QC Criteria

Dec 2, 2017

First Posted Date

Dec 7, 2017Actual

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

Dec 2, 2017

Last Update Posted Date

Dec 7, 2017Actual

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

compare the chair side time, clinical orthodontic attachment bond failure and accuracy of transfer between non custom attachment base and custom attachment base indirect techniques.

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

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non custom base attachment	Experimental		Device: non custom base attachment
custom base attachment	Active Comparator		Device: custom base attachment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non custom base attachment	Device	non custom base attachment	non custom base attachment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
chair side time	using stopwatch	an average of 30 minutes

Secondary Outcomes

Measure	Description	Time Frame
immediate bond failure	number of debonded attachments using hand instrument pressure	immediately after bonding

Other Outcomes

Measure	Description	Time Frame
accuracy of orthodontic attachments transfer	linear (mm) scale using geomagic software	one day after bonding
accuracy of orthodontic attachments transfer	angular (degrees) scale using geomagic software

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Patients should have

Maxillary sound teeth and undergoing fixed orthodontic treatment.
Space problems ranging from spacing to mild crowding.
Good oral hygiene.

Exclusion Criteria:

Patients with partially erupted teeth in the maxillary arch .
Signs of caries, large restorations fluorosis, hypoplasia or abnormalities of crown morphology.
The need of banding.
Bad oral hygiene measures.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided