Maxillary Transverse Deficiency (Posterior Crossbite) in Early Adolescent PatientsHYRAX_ RME_SMENCT07739498
Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents
A study testing Intervention 1: HYRAX expander with posterior disarticulatory resin bite turbos in people with Maxillary Transverse Deficiency (Posterior Crossbite) in Early Adolescent Patients, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Maxillary Transverse Deficiency (Posterior Crossbite) in Early Adolescent Patients
- What is being tested?
- Intervention 1: HYRAX expander with posterior disarticulatory resin bite turbos
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Orthodontic Department - Faculty of Dentistry Mansoura University
Al Mansurah
Faculty of Dentistry Mansoura University, 0020502267151, dentfac@mansoura.edu.eg
About this study
Official title: Effect of Posterior Disarticulatory Resin Bite Turbos on the Rate of Maxillary Expansion Using HYRAX Expander in Early Adolescent Patients: Randomized Controlled Clinical Trial
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.
Read the detailed description
This study is conducted as part of a Master's thesis in Orthodontics and aims to investigate the influence of posterior disarticulatory resin bite turbos on the rate of maxillary expansion achieved using a HYRAX expander in early adolescent patients.
The study evaluates whether modifying occlusal contacts can affect skeletal and dental responses during rapid maxillary expansion.
Participants will be monitored clinically throughout the expansion phase.
Participants will be assigned in two groups:
group 1: with posterior bite turbos group 2: without posterior bite turbos
Digital intraoral scans will be taken on a weekly basis to assess changes in maxillary dimensions and to accurately measure the rate and pattern of expansion over time.
These serial digital records provide high-resolution, non-invasive documentation of treatment progress.
CBCT will be taken before the expansion and after retention phase for skeletal and dental measurement .
- Being tested
- Intervention 1: HYRAX expander with posterior disarticulatory resin bite turbos, Intervention 2 (Control): HYRAX expander alone
- Keywords
- Maxillary transverse deficiency - Rapid maxillary expansion - HYRAX expander - Bite turbos - Orthodontics - Intraoral scanning - RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1: HYRAX expander with posterior disarticulatory resin bite turbosDevice
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.
Intervention 2 (Control): HYRAX expander aloneDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Intervention 2 (Control): HYRAX expander alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Skeletal transverse, vertical, nasal width changes and axial inclination of posterior teeth will be evaluated .
Measured: baseline and after three months of retention after complete active expansion
pain felt by the patient after activating the expansion screw
ain will be assessed using the Visual Analogue Scale (VAS), a 100 mm line with "no pain" at the left end and "the worst unbearable pain" at the right, which corresponds to a pain score between 0 and 10. All participants will be asked to place a vertical mark indicating the level of pain on the VAS 4 h after each activation for the first two weeks in diary sheet containing the actual size of a 100mm of VAS. 25
Measured: first two weeks in active phase of expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start15 Feb 2026
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Transverse Deficiency (Posterior Crossbite) in Early Adolescent PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donia Alashker, Principal investigator, Faculty of Dentistry Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739498
- Sponsor's protocol ID
- MS.26.02.145
- Acronym
- HYRAX_ RME_SME
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Posterior Disarticulatory Resin Bite Turbos on the Rate of Maxillary Expansion Using HYRAX Expander in Early Adolescent Patients: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07739498
- Acronym / sponsor ID
- HYRAX_ RME_SME / MS.26.02.145
- Keywords
- Maxillary transverse deficiency - Rapid maxillary expansion - HYRAX expander - Bite turbos - Orthodontics - Intraoral scanning - RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is conducted as part of a Master's thesis in Orthodontics and aims to investigate the influence of posterior disarticulatory resin bite turbos on the rate of maxillary expansion achieved using a HYRAX expander in early adolescent patients.
The study evaluates whether modifying occlusal contacts can affect skeletal and dental responses during rapid maxillary expansion.
Participants will be monitored clinically throughout the expansion phase.
Participants will be assigned in two groups:
group 1: with posterior bite turbos group 2: without posterior bite turbos
Digital intraoral scans will be taken on a weekly basis to assess changes in maxillary dimensions and to accurately measure the rate and pattern of expansion over time.
These serial digital records provide high-resolution, non-invasive documentation of treatment progress.
CBCT will be taken before the expansion and after retention phase for skeletal and dental measurement .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| group 1: HYRAX with posterior bite turbos | Experimental | Device: Intervention 1: HYRAX expander with posterior disarticulatory resin bite turbosParticipants 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. |
| Group 2 : Expansion without posterior bite turbos | Active comparator | Device: Intervention 2 (Control): HYRAX expander aloneParticipants 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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention 1: HYRAX expander with posterior disarticulatory resin bite turbosDescription: 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. | Device | group 1: HYRAX with posterior bite turbos |
| Intervention 2 (Control): HYRAX expander aloneParticipants 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. | Device | Group 2 : Expansion without posterior bite turbos |
Primary outcome
The effect of occlusal disarticulation on the rate of maxillary expansion by linear measurements made on digital models
Time frame: Baseline and weekly during the active phase of expansion and after 3 months of retention
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.
2 secondary outcomes
-The effect of the posterior disarticulation on alveolar bone changes by CBCT .
Time frame: baseline and after three months of retention after complete active expansion
pain felt by the patient after activating the expansion screw
Time frame: first two weeks in active phase of expansion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Donia Alashker principal investigator
Faculty of Dentistry Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1: HYRAX expander with posterior disarticulatory resin bite turbos in people with Maxillary Transverse Deficiency (Posterior Crossbite) in Early Adolescent Patients, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donia Alashker (00201557372170, donyaalashker7@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of occlusal disarticulation on the rate of maxillary expansion by linear measurements made on digital models (time frame: Baseline and weekly during the active phase of expansion and after 3 months of retention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.