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Dento-skeletal Effects of Quadhelix Versus Mini-hyrax Expanders in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Randomized Clinical Trial

NCT07465939 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-12

No results posted yet for this study

Summary

Regarding expansion in cleft lip and palate patients, very few clinical trials were found after searching literature and fewer randomized trials. This means that no enough evidence in literature is tackling expansion in cleft lip and palate patients.

To the best of our knowledge, this study will represent the first RCT to compare the dentoskeletal effects of mini-hyrax vs quadhelix. Since cleft cases usually need greater anterior than posterior expansion, both appliances are capable of anterior expansion. Nevertheless, no other study compared how much anterior expansion could be accomplished by either appliance.

Conditions

  • Maxillary Expansion in Cleft Lip and Palate Patients
  • Dentoskeletal Effects After Expansion Using Two Different Expanders

Interventions

DEVICE

Quadhelix Expander

Maxillary Expander

DEVICE

Minihyrax Expander

Maxillary Expander

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-29
Primary Completion
2026-04-30
Completion
2026-05-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07465939 on ClinicalTrials.gov