Effectiveness of Two Maxillary Expanders in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate

February 11, 2023 updated by: Mohamed Abd El-Ghafour, Cairo University

Effectiveness of Two Rapid Maxillary Expanders (Quadhelix vs Hyrax) in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate: A Randomized Clinical Trial

This randomized controlled trial is designed to compare between quadlelix appliance vs hyrax expander regrading the their effectiveness in maxillary expansion in patients with cleft.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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 Locations

  • Egypt
    • Giza
      • Cairo, Giza, Egypt, 00202
        • 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

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mixed dentition stage;
  • Both males and females;
  • Lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age;
  • Presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft;
  • Permanent first maxillary molars present;
  • Good periodontal health;
  • No previous orthodontic treatment; and

Exclusion Criteria:

  • Presence of a syndrome in companion with the present cleft defect.
  • Previous secondary alveolar bone grafting.
  • Taking medications affecting growth.

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
EXPERIMENTAL: Quadhelix Group
Device: Maxillary Expansion
2 appliances to expand the maxillary arch
ACTIVE_COMPARATOR: Hyrax Group
Device: Maxillary Expansion
2 appliances to expand the maxillary arch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maxillary Expansion
Time Frame: 6 months
Amount of Maxillary Expansion to be measured as distances (mm) on CBCTs and dental models.
6 months
Maxillary Expansion
Time Frame: 6 months
mount of Maxillary Expansion to be measured as angles (degrees) on CBCTs and dental models.
6 months

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 (ACTUAL)

July 2, 2020

Primary Completion (ACTUAL)

December 30, 2022

Study Completion (ACTUAL)

December 30, 2022

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (ACTUAL)

April 2, 2020

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 11, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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