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

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ClinicalTrials.gov Identifier: NCT03585881
Recruitment Status : Not yet recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Amany Ibrahim, Cairo University

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

Condition or disease Intervention/treatment Phase
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 Device: 3DPrinted Windowed Bracket- Positioning tray Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Evaluation of Accuracy of 3DPrinted Windowed Bracket- Positioning Guide Compared To Thermoformed Transfer Tray For Orthodontic Indirect Bonding A Randomized Controlled Trial
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: window bracket positioning tray Device: 3DPrinted Windowed Bracket- Positioning tray
3 D printed tray with windows for accurate positioning of brackets

No Intervention: conventional indirect boning tray



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. chairside time [ Time Frame: immediate ]
    digital stopwatch in seconds

  2. immediate bond failure [ Time Frame: immediate ]
    counting after bonding number of brackets or tubes failed immediately



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Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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Responsible Party: Amany Ibrahim, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03585881     History of Changes
Other Study ID Numbers: CEBD-CU-2018-04-18
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No