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

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

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.

Study Overview

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

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

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 4240310
      • 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

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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: abdullah mo ali al-thalabi, Msc candidate, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2023
• Primary Completion (Estimated): December 2, 2023
• Study Completion (Estimated): June 2, 2024

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Estimated): November 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: maxillary expansion
• Other Study ID Numbers: 15623

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