Accuracy of 3DPrinted Windowed Bracket- Positioning Guide... | NCT03585881

Studies
Accuracy of 3DPrinted Windowed Bracket- Positioning Guide Compared To Thermoformed Indirect Bonding Tray

NCT03585881

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jul 13, 2018Actual

Enrollment

132Estimated

Phase

Not Applicable

Conditions

Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding Tray
Accuracy of Bracket Transfer and Bond Failure Rate of Digitally Printed Transfer Tray With Windows and Conventional Thermoformed Transfer Tray

Interventions

3DPrinted Windowed Bracket- Positioning tray

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

Status Module

Record Verification Date

Jun 2018

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

Sep 2018Estimated

Primary Completion Date

Nov 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jun 8, 2018

First Submission Date that Met QC Criteria

Jul 1, 2018

First Posted Date

Jul 13, 2018Actual

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

Jul 1, 2018

Last Update Posted Date

Jul 13, 2018Actual

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

this study was aimed to evaluate of accuracy of 3DPrinted windowed Bracket- Positioning Guide in compare to Thermoformed Transfer Tray For Orthodontic Indirect Bonding

Detailed Description

Not provided

Conditions Module

Conditions

Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding Tray
Accuracy of Bracket Transfer and Bond Failure Rate of Digitally Printed Transfer Tray With Windows and Conventional Thermoformed Transfer Tray

Keywords

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

132Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
window bracket positioning tray	Experimental		Device: 3DPrinted Windowed Bracket- Positioning tray
conventional indirect boning tray	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3DPrinted Windowed Bracket- Positioning tray	Device	3 D printed tray with windows for accurate positioning of brackets	window bracket positioning tray

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
accuracy of 3D printed transfer tray with windows& conventional thermoformed transfer tray	using digital measurements on 3 shape software in mm degrees	immediate

Secondary Outcomes

Measure	Description	Time Frame
chairside time	digital stopwatch in seconds	immediate
immediate bond failure	counting after bonding number of brackets or tubes failed immediately

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: above 13 years.
Complete set of permanent teeth including second molar.
No sex predilection.
Class I Mild to moderate crowding (4-6 mm).

Exclusion Criteria:

Surface enamel defect that compromise bonding
No or poor patient's compliance.
Psychological problems.
Pathology at the site of intervention.
Insufficient crown height that contradicts bonding of brackets.
Labial and buccal Restorations.
Poor oral hygiene.
Severely rotated teeth

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.