Immediate Skeletal and Dento-alveolar Effects of Two and Four Mini-screw Supported Hyrax for Maxillary Expansion in Non-growing Patients

NCT06851728 | Completed DMC

• 1 other identifier: 33624
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects, therefore ,recently A minis crews assisted rapid expansion is recently introduced to overcome hence complications

Conditions

Transverse Maxillary Deficiency; Posterior Crossbite, Upper Airway

Outcome Measures

Primary Outcomes (1)

• Skeletal effects

  To compare the amount of skeletal expansion using linear (mm)measurement extracted from cone beam computed tomography pre and post-expansion

  the outcome will be assessed immediate post expansion (one month-tow month)

Secondary Outcomes (2)

• Dento-alveolar effects

  1-2 months

• Dento-alveolar effects

  1-2 months

Study Arms (2)

Group one

EXPERIMENTAL

two mini screws supported hyrax was used

Device: MARPE

Group two

EXPERIMENTAL

four minis crews supported hyrax was used

Device: MARPE

Interventions

MARPE DEVICE

treating patients with transverse maxillary deficiency using minis crews supported hybrid hyrax

Group one; Group two

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• adults male or female aged from 18-30 years with skeletal Maxillary constriction
• unilateral or bilateral Dental posterior cross-bite
• mid-palatal suture maturation (Grade C, D) according to F Angileri classification
• good oral hygiene

You may not qualify if:

• no functional crossbite due to premature contacts
• no previous orthodontic treatment
• no buccal crossbite
• no craniofacial anomalies or syndromes.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

11,ElSaraya street ,Almanyal ,CAIRO ,EGYPT

Cairo, Egypt

Location

Study Officials

• fady hussein fahim, PhD

  Associate proff

  STUDY DIRECTOR

• nada Omer elzawahry, PhD

  lecturer

  STUDY DIRECTOR

• elzubair osman salih, MSc

  MSc degree candidate

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc candidate, Cairo university, department of Orthodontics

Model Details: two experimental groups ,two screw supported and four screw supported hyrax

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 28, 2025
• Study Start: February 2, 2023
• Primary Completion: August 2, 2023
• Study Completion: December 4, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)