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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07465939
Acronym
RCT
Enrollment
24
Registered
2026-03-12
Start date
2025-05-29
Completion date
2026-05-01
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Maxillary Expansion, Cleft, Anterior constriction, Quadhelix, Mini-hyarx

Brief 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.

Detailed description

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.

Interventions

DEVICEQuadhelix Expander

Maxillary Expander

DEVICEMinihyrax Expander

Maxillary Expander

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Complete unilateral cleft lip and palate pts with anterior and/or posterior crossbite at mixed dentition stage prepared for secondary alveolar bone grafting.

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

1. Mixed dentition. 2. Both males and females. 3. Unilateral cleft lip and palate 4. Presence of maxillary constriction that needs maxillary expansion prior to secondary alveolar bone grafting. 5. Erupted first permanent maxillary molars. 6. Good periodontal health. 7. No previous orthodontic treatment

Exclusion criteria

1. Syndromic cleft lip and palate patients. 2. Previous secondary alveolar bone grafting. 3. Taking medications that influence growth. 4. Absence of teeth to support the expansion appliance

Design outcomes

Primary

MeasureTime frameDescription
Anterior transverse dento-skeletal effects measured by linear distance tool between deciduous upper canines on CBCT and digital models (axial view)6 monthsDigital models and CBCTs are used to compare dentoskeletal effects before and after expansion

Secondary

MeasureTime frameDescription
Maxillary and mandibular anteroposterior measurements measured by linear distance tool and angle measurement tool on CBCT and digital models (sagittal view)6 monthsDigital models \& CBCT
Vertical skeletal measurements measured by angle measurement tool (y-axis angle - SnMp) on CBCT (sagittal view)6 monthsCBCT
Dentoskeletal Effects measured by angle measurement tool on CBCT (Coronal view)6 monthsMolar inclination

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026