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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

Tracking Information
First Submitted Date  ICMJE June 8, 2018
First Posted Date  ICMJE July 13, 2018
Last Update Posted Date July 13, 2018
Estimated Study Start Date  ICMJE September 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2018)
  • chairside time [ Time Frame: immediate ]
    digital stopwatch in seconds
  • immediate bond failure [ Time Frame: immediate ]
    counting after bonding number of brackets or tubes failed immediately
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Accuracy of 3DPrinted Windowed Bracket- Positioning Guide Compared To Thermoformed Indirect Bonding Tray
Official Title  ICMJE Evaluation of Accuracy of 3DPrinted Windowed Bracket- Positioning Guide Compared To Thermoformed Transfer Tray For Orthodontic Indirect Bonding A Randomized Controlled Trial
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • 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
Intervention  ICMJE Device: 3DPrinted Windowed Bracket- Positioning tray
3 D printed tray with windows for accurate positioning of brackets
Study Arms  ICMJE
  • Experimental: window bracket positioning tray
    Intervention: Device: 3DPrinted Windowed Bracket- Positioning tray
  • No Intervention: conventional indirect boning tray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2018)
132
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03585881
Other Study ID Numbers  ICMJE CEBD-CU-2018-04-18
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amany Ibrahim, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP