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Evaluation Of Different Rapid Orthodontic Expansion Devices

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ClinicalTrials.gov Identifier: NCT03258411
Recruitment Status : Active, not recruiting
First Posted : August 23, 2017
Last Update Posted : October 15, 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 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 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 : February 5, 2019
Estimated Study Completion Date : April 1, 2019

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


Locations
Saudi Arabia
King Abdulaziz University, Faculty of Dentistry
Jeddah, Makkah, Saudi Arabia, 21589
Sponsors and Collaborators
King Abdulaziz University