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

Cleft Lip and Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04331977
• Other study ID #: 121
• Status: Completed
• Phase: N/A
• Start date: July 2, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate
• Maxillary Expansion

Intervention

Device:
• Maxillary Expansion
2 appliances to expand the maxillary arch

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maxillary Expansion	Amount of Maxillary Expansion to be measured as distances (mm) on CBCTs and dental models.	6 months
Primary	Maxillary Expansion	mount of Maxillary Expansion to be measured as angles (degrees) on CBCTs and dental models.	6 months