Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03585881
Recruitment Status : Not yet recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
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

Layout table for study information
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Layout table for additonal information
Responsible Party: Amany Ibrahim, principal investigator, Cairo University Identifier: NCT03585881    
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No