Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents

NCT07739498 | Recruiting DMC

• 1 other identifier: MS.26.02.145
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial aims to evaluate the effect of posterior disarticulatory resin bite turbos on the rate of maxillary expansion using a HYRAX expander in early adolescent patients. Participants will be randomly assigned to receive either maxillary expansion with posterior resin bite turbos or conventional expansion without bite turbos. The study will assess and compare the rate and effectiveness of maxillary expansion between the two groups during the treatment period. Clinical measurements will be recorded to evaluate skeletal and dental changes associated with the intervention.

Conditions

Maxillary Transverse Deficiency Requiring Rapid Maxillary Expansion in Early Adolescent Patients

Keywords

Maxillary transverse deficiency - Rapid maxillary expansion - HYRAX expander - Bite turbos - Orthodontics - Intraoral scanning - RCT

Outcome Measures

Primary Outcomes (1)

• The effect of occlusal disarticulation on the rate of maxillary expansion by linear measurements made on digital models

  Dental landmarks and measurements on models : d3 :Canine tip. d4: Central fissure of first premolar. d6 :Central fissure of first permanent molar. d\_3( inter canine width): Distance between left and right d3. d\_4 (inter first premolar width) : Distance between left and right d4. d\_6(inter first molar width): Distance between left and right d6.

  Baseline and weekly during the active phase of expansion and after 3 months of retention

Secondary Outcomes (2)

• -The effect of the posterior disarticulation on alveolar bone changes by CBCT .

  baseline and after three months of retention after complete active expansion

• pain felt by the patient after activating the expansion screw

  first two weeks in active phase of expansion

Study Arms (2)

group 1: HYRAX with posterior bite turbos

EXPERIMENTAL

Participants in this arm receive a HYRAX rapid maxillary expansion appliance combined with posterior disarticulatory resin bite turbos. The bite turbos are placed on posterior teeth to achieve occlusal disclusion, aiming to minimize occlusal interference during expansion and potentially enhance skeletal response. The HYRAX expander is activated according to a standardized protocol throughout the treatment period, with regular follow-up using clinical assessment and weekly intraoral scans.

Device: Intervention 1: HYRAX expander with posterior disarticulatory resin bite turbos

Group 2 : Expansion without posterior bite turbos

ACTIVE COMPARATOR

Participants in this arm receive a HYRAX rapid maxillary expansion appliance without the use of posterior disarticulatory resin bite turbos. The appliance is activated according to a standardized expansion protocol similar to the experimental group. Patients are followed throughout the treatment period with regular clinical assessments and weekly intraoral scans to monitor changes in maxillary dimensions.

Device: Intervention 2 (Control): HYRAX expander alone

Interventions

Intervention 1: HYRAX expander with posterior disarticulatory resin bite turbos DEVICE

Description: Arm 1: Participants in this group receive a HYRAX rapid maxillary expansion appliance combined with posterior disarticulatory resin bite turbos. The bite turbos are placed on the posterior teeth to disclude the occlusion, aiming to reduce occlusal interference and potentially enhance skeletal response during maxillary expansion. The HYRAX appliance is activated according to a standardized expansion protocol.

group 1: HYRAX with posterior bite turbos

Intervention 2 (Control): HYRAX expander alone DEVICE

Participants in this group receive a HYRAX rapid maxillary expansion appliance alone without the use of posterior bite turbos. The appliance is activated following the same standardized expansion protocol as the intervention group.

Group 2 : Expansion without posterior bite turbos

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 10-14 years.
• Bilateral posterior cross bite.
• Functional lateral cross bite.
• Good general and oral health.
• Normal to decreased vertical height )average FMA 29.7 °± 4.2 °).23

You may not qualify if:

• Patients with cleft lip and palate.
• Severe facial asymmetry.
• Anterior open bite.
• Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
• Previous orthodontic treatment.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Orthodontic Department - Faculty of Dentistry Mansoura University

Al Mansurah, Egypt

RECRUITING

Study Officials

• Donia Alashker

  Faculty of Dentistry Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donia Alashker

CONTACT

00201557372170; donyaalashker7@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed as a parallel-group randomized controlled clinical trial with two study arms. Participants are randomly allocated to receive either a HYRAX expander with posterior disarticulatory resin bite turbos or a HYRAX expander alone. Both groups are followed concurrently throughout the treatment period, and outcomes are assessed at predefined intervals using clinical evaluation and weekly digital intraoral scans to measure the rate of maxillary expansion.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)