Cross BitePhase 1NCT03258411
Evaluation Of Different Rapid Orthodontic Expansion Devices
A Phase 1 study testing Rapid Expansion of palatal suture in people with Cross Bite, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Evaluating and comparing the short term effects of different palatal expanders on the amount of palatal expansion and buccal tipping of posterior teeth. Hypothesis: H0: There is no difference in the short term effects between the different palatal expanders. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Cross Bite
- What is being tested?
- Rapid Expansion of palatal suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Feb 2015to 1 Apr 2019
- Phase
- Phase 1
- 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Non-syndromic adolescent patients.
- Patients in need for palatal expansion treatment.
- Average face height.
- No previous orthodontic treatment.
Who cannot join
- Syndromic adolescent patients.
- Patients not in need for palatal expansion treatment.
- Non-average face height.
- Previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdulaziz University, Faculty of Dentistry
Jeddah, Mecca Region, 21589
About this study
Official title: Comparison of The Short Term Effects of Different Palatal Expanders Using CBCT.
Evaluating and comparing the short term effects of different palatal expanders on the amount of palatal expansion and buccal tipping of posterior teeth.
Hypothesis:
H0: There is no difference in the short term effects between the different palatal expanders.
H1: There is a significant difference in the short term effects between the different palatal expanders.
- Conditions
- Cross Bite
- Being tested
- Rapid Expansion of palatal suture
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Expansion of palatal sutureDevice
| Study group | Role | What they receive |
|---|---|---|
| Haas group (H) | Active comparator | Rapid Expansion of palatal suture device: tooth-tissue supported expander (Haas (H)). Receives: Device: Rapid Expansion of palatal suture |
| Hyrax (Hx) | Active comparator | Rapid Expansion of palatal suture device: tooth anchored expander (Hyrax (Hx)). Receives: Device: Rapid Expansion of palatal suture |
| Miniscrew-supported (MHx) | Active comparator | Rapid Expansion of palatal suture device: bone anchored expander (Temporary anchorage devices(miniscrew)-supported (MHx)) Receives: Device: Rapid Expansion of palatal suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of skeletal and dental expansion
These are linear measurements which will be measured in millimetres in the first and the second cone beam computed tomography images and the difference will be calculated.
Measured: 3 months
Amount of dental inclination
These are angular measurements which will be measured in degrees in the first and the second cone beam computed tomography images and the difference will be calculated.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start10 Feb 2015
- Primary completion5 Feb 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cross BiteStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Najla Alhamdani, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258411
- Sponsor's protocol ID
- BBRPE
- Status last verified
- Apr 2020
- First submitted
- 22 Jul 2017
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Mosleh MI, Kaddah MA, Abd ElSayed FA, ElSayed HS. Comparison of transverse changes during maxillary expansion with 4-point bone-borne and tooth-borne maxillary expanders. Am J Orthod Dentofacial Orthop. 2015 Oct;148(4):599-607. doi: 10.1016/j.ajodo.2015.04.040.
PubMed 26432315Lagravere MO, Carey J, Heo G, Toogood RW, Major PW. Transverse, vertical, and anteroposterior changes from bone-anchored maxillary expansion vs traditional rapid maxillary expansion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):304.e1-12; discussion 304-5. doi: 10.1016/j.ajodo.2009.09.016.
PubMed 20197161
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Short Term Effects of Different Palatal Expanders Using CBCT.
- ClinicalTrials.gov ID
- NCT03258411
- Acronym / sponsor ID
- BBRPE
- Conditions
- Cross Bite
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 10 Feb 2015 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 23 Aug 2017 (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.
Evaluating and comparing the short term effects of different palatal expanders on the amount of palatal expansion and buccal tipping of posterior teeth.
Hypothesis:
H0: There is no difference in the short term effects between the different palatal expanders.
H1: There is a significant difference in the short term effects between the different palatal expanders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Haas group (H) | Active comparator | Device: Rapid Expansion of palatal sutureRapid Expansion of palatal suture device: tooth-tissue supported expander (Haas (H)). |
| Hyrax (Hx) | Active comparator | Device: Rapid Expansion of palatal sutureRapid Expansion of palatal suture device: tooth anchored expander (Hyrax (Hx)). |
| Miniscrew-supported (MHx) | Active comparator | Device: Rapid Expansion of palatal sutureRapid Expansion of palatal suture device: bone anchored expander (Temporary anchorage devices(miniscrew)-supported (MHx)) |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Non-syndromic adolescent patients.
- Patients in need for palatal expansion treatment.
- Average face height.
- No previous orthodontic treatment.
Key exclusion criteria (4 listed)
- Syndromic adolescent patients.
- Patients not in need for palatal expansion treatment.
- Non-average face height.
- 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 |
|---|---|---|
| Rapid Expansion of palatal suture | Device | Haas group (H), Hyrax (Hx), Miniscrew-supported (MHx) |
Primary outcome
Amount of skeletal and dental expansion
Time frame: 3 months
These are linear measurements which will be measured in millimetres in the first and the second cone beam computed tomography images and the difference will be calculated.
Amount of dental inclination
Time frame: 3 months
These are angular measurements which will be measured in degrees in the first and the second cone beam computed tomography images and the difference will be calculated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Background: PubMed 26432315Mosleh MI, Kaddah MA, Abd ElSayed FA, ElSayed HS. Comparison of transverse changes during maxillary expansion with 4-point bone-borne and tooth-borne maxillary expanders. Am J Orthod Dentofacial Orthop. 2015 Oct;148(4):599-607. doi: 10.1016/j.ajodo.2015.04.040.
- Background: PubMed 20197161Lagravere MO, Carey J, Heo G, Toogood RW, Major PW. Transverse, vertical, and anteroposterior changes from bone-anchored maxillary expansion vs traditional rapid maxillary expansion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):304.e1-12; discussion 304-5. doi: 10.1016/j.ajodo.2009.09.016.
- Individual participant dataSharing planned: Undecided
Related trials for Cross Bite
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Maxillary Transverse Deficiency (Posterior Crossbite) in Early Adolescent Patients
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Masticatory Efficiency, Bite Force, and Patient-Reported Outcomes in Patients Rehabilitated With Complete and Partial Dentures Supported by Teeth, Mini-Implants, or Conventional Implants
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rapid Expansion of palatal suture in people with Cross Bite, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 4 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: finished, as of the sponsor's last update on 7 Apr 2020. 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 Saudi Arabia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of skeletal and dental expansion (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03258411, which also lists 2 linked publications.
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 7 Apr 2020.