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

Not Applicable

Active, not recruiting

• Conditions: Transverse Maxillary Deficiency
• Interventions: Device: Hybrid hyrax

• Registration Number: NCT06020183
• Lead Sponsor: Cairo University

Brief Summary

This study aims to evaluate the Skeletal and Dento-alveolar expansion in adult patents using Four Mini-screws Supported Hyrax in compare with untreated control group.

Detailed Description

Aim of the study: To evaluate the Effectiveness of Four Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood

Methodology:

* Essential record for orthodontic treatment will be taken.

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

* Four 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.

* The appliance will be cemented 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

Study Timeline

• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-08-30
• Study First Posted: 2023-08-31
• Study Start: 2023-09-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-21
• Primary Completion: 2024-07-02
• Study Completion: 2024-08-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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

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Exclusion Criteria

• Scissor-bite
• Orthodontically-treated
• functional cross bite due to premature occlusal contact
• patients with a syndrome
• cleft patients
• Mid-palatal suture maturation(Grade A.B,E) according to F Angileri classification

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid Hyrax	Hybrid hyrax	these patents will be treated using Four mini-screws supported hyrax

Primary Outcome Measures

Name	Time	Method
Skeletal maxillary expansion	5 months interval between pre and post-expansion	To compare the amount of skeletal expansion pre and post expansion

Secondary Outcome Measures

Name	Time	Method
Dento-alaveolar expansion	5 months interval between pre and post-expansion	To compare the amount of Dento-alaveolar expansion pre and post expansion

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo university; 🇪🇬 Cairo, Giza, Egypt