Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding TrayNCT03585881

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

A study testing 3DPrinted Windowed Bracket- Positioning tray in people with Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding Tray and Accuracy of Bracket Transfer and Bond Failure Rate of Digitally Printed Transfer Tray With Windows and Conventional Thermoformed Transfer Tray, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 13 to 25 years
Conditions the study is for: 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
What is being tested?: 3DPrinted Windowed Bracket- Positioning tray
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 132 participants
Where: No sites listed yet
Study dates: Sep 2018to Dec 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 25 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: Evaluation of Accuracy of 3DPrinted Windowed Bracket- Positioning Guide Compared To Thermoformed Transfer Tray For Orthodontic Indirect Bonding A Randomized Controlled Trial

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

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
Being tested: 3DPrinted Windowed Bracket- Positioning tray

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3DPrinted Windowed Bracket- Positioning trayDevice
3 D printed tray with windows for accurate positioning of brackets

Study groups in NCT03585881
Study group	Role	What they receive
window bracket positioning tray	Experimental	Not described Receives: Device: 3DPrinted Windowed Bracket- Positioning tray
conventional indirect boning tray	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

accuracy of 3D printed transfer tray with windows& conventional thermoformed transfer tray
using digital measurements on 3 shape software in mm degrees
Measured: immediate

Secondary outcomes (2)

chairside time
digital stopwatch in seconds
Measured: immediate
immediate bond failure
counting after bonding number of brackets or tubes failed immediately
Measured: immediate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2018Dec 2018

First posted13 Jul 2018
Study startSep 2018 (estimated)
Primary completionNov 2018 (estimated)
Study completionDec 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding TrayStudies of the same condition, open and under way.
More trials run by Cairo UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 132 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03585881
Sponsor's protocol ID: CEBD-CU-2018-04-18
Status last verified: Jun 2018
First submitted: 8 Jun 2018
Last updated: 13 Jul 2018
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Accuracy of 3DPrinted Windowed Bracket- Positioning Guide Compared To Thermoformed Transfer Tray For Orthodontic Indirect Bonding A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03585881
Acronym / sponsor ID: CEBD-CU-2018-04-18
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
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 132 participants (estimated)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Study start: Sep 2018 (estimated)
Primary completion: Nov 2018 (estimated)
Study completion: Dec 2018 (estimated)
First posted: 13 Jul 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
window bracket positioning tray	Experimental	Device: 3DPrinted Windowed Bracket- Positioning tray
conventional indirect boning tray	No intervention	–

Who may qualify

Ages: 13 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
3DPrinted Windowed Bracket- Positioning tray3 D printed tray with windows for accurate positioning of brackets	Device	window bracket positioning tray

Primary outcome

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

2 secondary outcomes

chairside time
Time frame: immediate
immediate bond failure
Time frame: immediate

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

accuracy of 3D printed transfer tray with windows& conventional thermoformed transfer tray (time frame: immediate). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03585881.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.