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

Immediate Skeletal and Dento-alveolar Effects of Two and Four Mini-screw Supported Hyrax for Maxillary Expansion in Non-growing Patients: A Randomized Controlled Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Transverse Maxillary Deficiency; Posterior Crossbite, Upper Airway
• Intervention / Treatment: Device: MARPE

Detailed Description

transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects such as buccal tipping, marginal bone loss, dento aloveolar expansion.

in such cases , surgically assisted rapid palatal expansion used to be the option of choice ,due to the invasiveness of the procedure and co-morbidity associated with it ,minis crews assisted rapid expansion is recently introduced to overcome the complications of both convectional and surgically assisted rapid palatal expansion

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • 11,ElSaraya street ,Almanyal ,CAIRO ,EGYPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group one; two mini screws supported hyrax was used	Device: MARPE; treating patients with transverse maxillary deficiency using minis crews supported hybrid hyrax
Experimental: Group two; four minis crews supported hyrax was used	Device: MARPE; treating patients with transverse maxillary deficiency using minis crews supported hybrid hyrax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dento-alveolar effects	To compare the amount of Dento-alveolar expansion using linear (mm) measurement extracted from cone beam computed tomography pre and post-expansion	1-2 months
Dento-alveolar effects	To compare the amount of Dento-alveolar expansion using angular(degree) measurement extracted from cone beam computed tomography pre and post-expansion	1-2 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: fady hussein fahim, PhD, Associate proff; Study Director: nada Omer elzawahry, PhD, lecturer; Study Director: elzubair osman salih, MSc, MSc degree candidate

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Actual): August 2, 2023
• Study Completion (Actual): December 4, 2024

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 33624

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No