Evaluation of Modified Hyrax Versus Quad Helix in Treatment of Posterior Cross Bite

March 7, 2024 updated by: Sally Mohamed Mosallam, Cairo University

A Comparative Evaluation of Modified Hyrax Versus Quad Helix in Treatment of Children With Posterior Cross Bite: Randomized Controlled Trial

This study will be performed to evaluate the treatment of posterior cross-bite with modified hyrax & Quad helix appliances and to compare which one will provide better results in relation to chewing difficulty in children with posterior cross- bite in mixed dentition

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be performed to evaluate the treatment of posterior cross-bite with modified hyrax & Quad helix appliances and to compare which one will provide better results in relation to chewing difficulty as a primary outcome of this study and also evaluate the increase in the inter maxillary width , sleep apnea and signs & symptoms of tempro-mandibular joints disorder in children with posterior cross- bite in mixed dentition Cases will be examined within a regular interval up to one year

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children with posterior cross-bite in mixed dentition stage.
  • Children with normal and mild growth pattern.
  • Children with completely erupted upper first molars.

Exclusion Criteria:

  • Children with advanced periodontal diseases.
  • Children having general diseases, syndromes.
  • Children with previous orthodontic.
  • Children with severe horizontal growth patterns.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Modified Hyrax
Appliance used for rapid maxillary expansion
Device: modified hyrax
Appliance used for rapid maxillary expansion
Active Comparator: Quad Helix
Appliance used for slow maxillary expansion
Device: quad helix
device use for slow maxillary expansion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chewing difficulty
Time Frame: one year
the outcome will be measured by visual analogue scale
one year

Collaborators and Investigators

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

Sponsor

Cairo University

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123789

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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