Evaluation Of Different Rapid Orthodontic Expansion Devices

April 5, 2020 updated by: Najla Alhamdani, King Abdulaziz University

Comparison of The Short Term Effects of Different Palatal Expanders Using CBCT.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Makkah
      • Jeddah, Makkah, Saudi Arabia, 21589
        • King Abdulaziz University, Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 10, 2015

Primary Completion (ACTUAL)

February 5, 2019

Study Completion (ACTUAL)

April 1, 2019

Study Registration Dates

First Submitted

July 22, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (ACTUAL)

August 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 5, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBRPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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