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Evaluation Of Different Rapid Orthodontic Expansion Devices

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ClinicalTrials.gov Identifier: NCT03258411
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Najla Alhamdani, King Abdulaziz University

Brief Summary:

Evaluating and comparing the short term effects of different palatal expanders on the amount of palatal expansion and buccal tipping of posterior teeth.

Hypothesis:

H0: There is no difference in the short term effects between the different palatal expanders.

H1: There is a significant difference in the short term effects between the different palatal expanders.


Condition or disease Intervention/treatment Phase
Cross Bite Device: Rapid Expansion of palatal suture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of The Short Term Effects of Different Palatal Expanders Using CBCT.
Actual Study Start Date : February 10, 2015
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : August 30, 2018

Arm Intervention/treatment
Active Comparator: Haas group (H)
Rapid Expansion of palatal suture device: tooth-tissue supported expander (Haas (H)).
Device: Rapid Expansion of palatal suture
Active Comparator: Hyrax (Hx)
Rapid Expansion of palatal suture device: tooth anchored expander (Hyrax (Hx)).
Device: Rapid Expansion of palatal suture
Active Comparator: Miniscrew-supported (MHx)
Rapid Expansion of palatal suture device: bone anchored expander (Temporary anchorage devices(miniscrew)-supported (MHx))
Device: Rapid Expansion of palatal suture



Primary Outcome Measures :
  1. Amount of skeletal and dental expansion [ Time Frame: 3 months ]
    These are linear measurements which will be measured in millimetres in the first and the second cone beam computed tomography images and the difference will be calculated.

  2. Amount of dental inclination [ Time Frame: 3 months ]
    These are angular measurements which will be measured in degrees in the first and the second cone beam computed tomography images and the difference will be calculated.



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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-syndromic adolescent patients.
  • Patients in need for palatal expansion treatment.
  • Average face height.
  • No previous orthodontic treatment.

Exclusion Criteria:

  • Syndromic adolescent patients.
  • Patients not in need for palatal expansion treatment.
  • Non-average face height.
  • Previous orthodontic treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258411


Contacts
Contact: Najla A Alhamdani, BDS +966558049455 najlaah88@gmail.com
Contact: Ali R Aljuhani, MHSM +966505646338 dentistksa@yahoo.com

Locations
Saudi Arabia
King Abdulaziz University, Faculty of Dentistry Recruiting
Jeddah, Makkah, Saudi Arabia, 21589
Contact: Reem Alansari, Phd    +966505533276    ralansari@kau.edu.sa   
Sponsors and Collaborators
King Abdulaziz University