Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07465939

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry Cairo university

Giza, Manial, 11553, Egypt

About this study

Maxillary expansion is usually performed before the secondary alveolar bone grafting procedure. Expansion improves the maxillary arch morphology and causes the segmental alignment creating appropriate conditions for bone grafting surgery as well as correcting the posterior crossbites. An important treatment objective in cleft cases is to achieve greater anterior than posterior maxillary expansion since there is a greater anterior than posterior maxillary constriction in most of those patients. Variable appliances have been used for maxillary arch expansion in cleft patients.

  • Hyrax expanders exert parallel forces to the alveolar bones and the maxillary complex, generating similar amounts of anterior as well as posterior expansion and might be indicated for patients with overall maxillary transverse deficiency. While with patients of greater anterior constriction, Hyrax expander must be frequently interrupted before the full correction of the anterior transverse deficiency in order to avoid the occurrence of a posterior buccal crossbite.
  • Fan-shape expanders and mini-hyrax (supported on the first premolars and associated to a transpalatal arch cemented to the first molars) enhanced expansion in the maxillary anterior region and restricted posterior expansion.
  • Mini-hyrax (supported on the first permanent molars) can expand anteriorly as well as posteriorly and was found comparable to hyrax.

I this study we are comparing the dentoskeletal effects of quadhelix versus mini-hyrax utilizing CBCT and digital models performed before and after expansion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mixed dentition.
  • Both males and females.
  • Unilateral cleft lip and palate
  • Presence of maxillary constriction that needs maxillary expansion prior to secondary alveolar bone grafting.
  • Erupted first permanent maxillary molars.
  • Good periodontal health.
  • No previous orthodontic treatment

Exclusion criteria

  • Syndromic cleft lip and palate patients.
  • Previous secondary alveolar bone grafting.
  • Taking medications that influence growth.
  • Absence of teeth to support the expansion appliance

Treatment and study plan

Quadhelix Expander

Device

Maxillary Expander

Minihyrax Expander

Device

Maxillary Expander

Primary outcomes

  1. Anterior transverse dento-skeletal effects measured by linear distance tool between deciduous upper canines on CBCT and digital models (axial view)

    Time frame: 6 months

    Digital models and CBCTs are used to compare dentoskeletal effects before and after expansion

Secondary outcomes

  1. Maxillary and mandibular anteroposterior measurements measured by linear distance tool and angle measurement tool on CBCT and digital models (sagittal view)

    Time frame: 6 months

    Digital models & CBCT

  2. Vertical skeletal measurements measured by angle measurement tool (y-axis angle - SnMp) on CBCT (sagittal view)

    Time frame: 6 months

    CBCT

  3. Dentoskeletal Effects measured by angle measurement tool on CBCT (Coronal view)

    Time frame: 6 months

    Molar inclination

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: RCT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.