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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Transverse Maxillary Deficiency
• Intervention / Treatment: Device: Hybrid hyrax

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 23646375
      • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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
• Mid-palatal suture maturation(Grade A.B,E) according to F Angileri classification

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hybrid Hyrax; these patents will be treated using Four mini-screws supported hyrax	Device: Hybrid hyrax; these patents will be treated using Four mini-screws supported hybrid hyrax; Other Names: MARPE(miniscrews-assisted rapid palatal expander)
No Intervention: untreated control group; Ethically ,these patents will be treated at the end of the study using the same appliance used for the experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal maxillary expansion	To compare the amount of skeletal expansion pre and post expansion	5 months interval between pre and post-expansion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dento-alaveolar expansion	To compare the amount of Dento-alaveolar expansion pre and post expansion	5 months interval between pre and post-expansion

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Elzubair Osman, Master Degree student ,Faculty of Dentistry, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2023
• Primary Completion (Estimated): July 2, 2024
• Study Completion (Estimated): August 6, 2024

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: maxillary expasnion
• Other Study ID Numbers: 14623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No