Effectiveness of Two 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: NCT06130748
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2023-04-02
• Status Verified: 2023-11
• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-11-08
• Last Update Submitted: 2023-11-08
• Study First Posted: 2023-11-14
• Last Update Posted: 2023-11-14
• Primary Completion: 2023-12-02
• Study Completion: 2024-06-02

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid Hyrax	Hybrid Hyrax	Device: Hybrid hyrax these patents will be treated using Two mini-screws supported hybrid hyrax Other Names: • MARPE(miniscrews-assisted rapid palatal expander)

Primary Outcome Measures

Name	Time	Method
Skeletal maxillary expansion To compare the amount of skeletal expansion pre and post expansion	the outcome will be assessed five months 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

Secondary Outcome Measures

Name	Time	Method
Dento-alaveolar expansion	the outcome will be assessed five months post-expansion	To compare the amount of dento-alveolar expansion using linear and angular measurements extracted from cone beam computed tomography pre and post-expansion

Trial Locations

Locations (1)

faculty of dentistry, Cairo university; 🇪🇬 Cairo, Giza, Egypt