Posterior Cross BiteNCT06300775
Evaluation of Modified Hyrax Versus Quad Helix in Treatment of Posterior Cross Bite
A study testing modified hyrax and quad helix in people with Posterior Cross Bite, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be performed to evaluate the treatment of posterior cross-bite with modified hyrax \& Quad helix appliances and to compare which one will provide better results in relation to chewing difficulty in children with posterior cross- bite in mixed dentition Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Posterior Cross Bite
- What is being tested?
- modified hyrax and quad helix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with posterior cross-bite in mixed dentition stage.
- Children with normal and mild growth pattern.
- Children with completely erupted upper first molars.
Who cannot join
- Children with advanced periodontal diseases.
- Children having general diseases, syndromes.
- Children with previous orthodontic.
- Children with severe horizontal growth patterns.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo univeristry
Cairo
ola mostafa, prof, 01006030036, ola.omar@dentistry.cu.edu.eg
rasha adel, lecture, 01007505888, rasha.adel@dentistry.cu.edu.com
About this study
Official title: A Comparative Evaluation of Modified Hyrax Versus Quad Helix in Treatment of Children With Posterior Cross Bite: Randomized Controlled Trial
This study will be performed to evaluate the treatment of posterior cross-bite with modified hyrax \& Quad helix appliances and to compare which one will provide better results in relation to chewing difficulty in children with posterior cross- bite in mixed dentition
Read the detailed description
This study will be performed to evaluate the treatment of posterior cross-bite with modified hyrax \& Quad helix appliances and to compare which one will provide better results in relation to chewing difficulty as a primary outcome of this study and also evaluate the increase in the inter maxillary width , sleep apnea and signs \& symptoms of tempro-mandibular joints disorder in children with posterior cross- bite in mixed dentition Cases will be examined within a regular interval up to one year
- Conditions
- Posterior Cross Bite
- Being tested
- modified hyrax, quad helix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified hyraxDevice
Appliance used for rapid maxillary expansion
quad helixDevice
device use for slow maxillary expansion
| Study group | Role | What they receive |
|---|---|---|
| Modified Hyrax | Active comparator | Appliance used for rapid maxillary expansion Receives: Device: modified hyrax |
| Quad Helix | Active comparator | Appliance used for slow maxillary expansion Receives: Device: quad helix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chewing difficulty
the outcome will be measured by visual analogue scale
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Cross BiteStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Modified Hyrax Versus Quad Helix
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Mohamed Mosallam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300775
- Sponsor's protocol ID
- 123789
- Status last verified
- Mar 2024
- First submitted
- 27 Oct 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Modified Hyrax Versus Quad Helix in Treatment of Children With Posterior Cross Bite: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06300775
- Acronym / sponsor ID
- 123789
- Conditions
- Posterior Cross Bite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 8 Mar 2024 (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 study will be performed to evaluate the treatment of posterior cross-bite with modified hyrax \& Quad helix appliances and to compare which one will provide better results in relation to chewing difficulty in children with posterior cross- bite in mixed dentition
Detailed description
This study will be performed to evaluate the treatment of posterior cross-bite with modified hyrax \& Quad helix appliances and to compare which one will provide better results in relation to chewing difficulty as a primary outcome of this study and also evaluate the increase in the inter maxillary width , sleep apnea and signs \& symptoms of tempro-mandibular joints disorder in children with posterior cross- bite in mixed dentition Cases will be examined within a regular interval up to one year
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Modified Hyrax Versus Quad Helix
| Arm | Type | Receives |
|---|---|---|
| Modified Hyrax | Active comparator | Device: modified hyraxAppliance used for rapid maxillary expansion |
| Quad Helix | Active comparator | Device: quad helixAppliance used for slow maxillary expansion |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children with posterior cross-bite in mixed dentition stage.
- Children with normal and mild growth pattern.
- Children with completely erupted upper first molars.
Key exclusion criteria (4 listed)
- Children with advanced periodontal diseases.
- Children having general diseases, syndromes.
- Children with previous orthodontic.
- Children with severe horizontal growth patterns.
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 |
|---|---|---|
| modified hyraxAppliance used for rapid maxillary expansion | Device | Modified Hyrax |
| quad helixdevice use for slow maxillary expansion | Device | Quad Helix |
Primary outcome
Chewing difficulty
Time frame: one year
the outcome will be measured by visual analogue scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified hyrax and quad helix in people with Posterior Cross Bite, run by Cairo 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sally mosallam, PH degree (01004288894, sally.mosallam@dentistry.cu.edu.eg.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chewing difficulty (time frame: one year). 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 8 Mar 2024.