Effectiveness of Two Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood

Transverse Maxillary Deficiency Clinical Trial

Official title:

Effectiveness of Two Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood: A Randomized Control Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06130748
• Other study ID #: 15623
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2, 2023
• Est. completion date: June 2, 2024

Study information

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

Clinical Trial Summary

The study aiming at evaluation of the Skeletal and Dento-alveolar expansion in adult patents using Two Mini-screws Supported Hyrax compared with untreated control group.

Description:

Methodology:

• Basic orthodontic record will be taken.

• impression with bands on upper first molars will be taken.

• Two eyelets will be soldered to the body of the hyrax appliance (size 10, Dentaurum, Germany).

• CBCT will be taken while patient wearing 1 mm thickness vacuum on the lower arch to dis-occlude both arches.

• Delivery, check the retention and fitness of the appliance.

• Cementation of the appliance using band cement(compomer).

• Using 3M contra-angle driver, the screws (Tomas screw size 10, Dentaurum, Germany) will be loaded and inserted.

• Activation of the appliance by opening it two turns immediately, followed by two turns everyday till cross bite correction or appearance of midline diastema.

• Closure of the device, and leave the appliance in-situ for five months as a retention.

• Post-expansion CBCT will be taken and continue fixed orthodontic treatment. Outcome:

skeletal and dento-alveolar expansion will be evaluated

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: June 2, 2024
• Est. primary completion date: December 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Unilateral or bilateral Dental posterior cross-bite

• Skeletal Maxillary constriction

• Male and female patients.

• Chronological age (18-30 years).

• Mid-palatal suture maturation (Grade C,D ) according to F Angileri classification

• Good oral hygiene.

• No craniofacial anomalies or syndromes

Exclusion Criteria:

• Scissor-bite

• Orthodontically-treated

• functional cross bite due to premature occlusal contact

• patients with a syndrome

• cleft patients

Related Conditions & MeSH terms

• Transverse Maxillary Deficiency

Intervention

Device:
• Hybrid Hyrax
these patents will be treated using Two mini-screws supported hybrid hyrax

Locations

Country	Name	City	State
Egypt	faculty of dentistry, Cairo university	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	Skeletal maxillary expansion To compare the amount of skeletal expansion pre and post expansion	To compare the amount of skeletal expansion using linear and angular measurements and the expansion pattern of mid-palatal suture extracted from cone beam computed tomography pre and post expansion	the outcome will be assessed five months post-expansion
Secondary	Dento-alaveolar expansion	To compare the amount of dento-alveolar expansion using linear and angular measurements extracted from cone beam computed tomography pre and post-expansion	the outcome will be assessed five months post-expansion