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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04331977

Enrollment

Registered

2020-04-02

Start date

2020-07-02

Completion date

2022-12-30

Last updated

2023-02-14

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

Conditions

Cleft Lip and Palate, Maxillary Expansion

Brief summary

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.

Interventions

DEVICEMaxillary Expansion

2 appliances to expand the maxillary arch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Maxillary Expansion	6 months	Amount of Maxillary Expansion to be measured as distances (mm) on CBCTs and dental models.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026