Expansion of Maxillary ArchNCT05899530
Dentoskeletal Changes Expansion Using Invisalign Versus Conventional Expander
A study testing Invisalign and Conventional expander in people with Expansion of Maxillary Arch and Maxillary Hypoplasia, run by Al-Azhar University.
Trial summary
Cbct evaluation of dentoskeletal changes after expansion using Invisalign versus conventional expander Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Expansion of Maxillary Arch, Maxillary Hypoplasia
- What is being tested?
- Invisalign and Conventional expander
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2023to 31 May 2024
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age (12-16)
- Good oral hygiene
- Constricted maxilla or moderate crowding
Who cannot join
- Patient receive drugs
- Periodontal diseas
- Past Orthodontic treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Dentoskeletal Changes After Expansion Using Invisalign Versus Conventional Expander Prospective Clinical Study
Cbct evaluation of dentoskeletal changes after expansion using Invisalign versus conventional expander
Read the detailed description
Using cbct for evaluation of dentoskeletal changes after expansion using Invisalign versus conventional expander hyrax
- Conditions
- Expansion of Maxillary Arch, Maxillary Hypoplasia
- Being tested
- Invisalign, Conventional expander
- Keywords
- Expander, Hyrax, Invisalign
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InvisalignDevice
Also called Hyrax
Expansion using Invisalign versus conventional expander
Conventional expanderDevice
conventional expander
| Study group | Role | What they receive |
|---|---|---|
| Conventional expander | Active comparator | Expansion using conventional orthodontic expander(hyrax) Receives: Device: Conventional expander |
| Invisalign | Experimental | Expansion with Invisalign appliance Receives: Device: Invisalign |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear amount of midpalatal Suture opening
Apperance of Distema , calculate the amount of general space
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start22 Jul 2023 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Expansion of Maxillary ArchStudies 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
- Expansion of maxillary arch by 2 different techniques including conventional expander in one group compared with expansion with clear aligner.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Abdo Ibrahim, Al-Azhar University
- Investigators
- Saleh A Saleh, Professor, Study director, Al-Azhar UniversityMohamad A Salem, Professor, Study director, Al-Azhar UniversityMohsena A Abdarrazik, Lecturer, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899530
- Sponsor's protocol ID
- AlazharU ASAIbrahim
- Other IDs
- S.A.Saleh, M.A.Salem, M.A.Abdarrazik
- Status last verified
- Jun 2023
- First submitted
- 25 May 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dentoskeletal Changes After Expansion Using Invisalign Versus Conventional Expander Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT05899530
- Acronym / sponsor ID
- AlazharU ASAIbrahim
- Conditions
- Expansion of Maxillary Arch, Maxillary Hypoplasia
- Keywords
- Expander, Hyrax, Invisalign
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 22 Jul 2023 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 12 Jun 2023 (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.
Cbct evaluation of dentoskeletal changes after expansion using Invisalign versus conventional expander
Detailed description
Using cbct for evaluation of dentoskeletal changes after expansion using Invisalign versus conventional expander hyrax
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Expansion of maxillary arch by 2 different techniques including conventional expander in one group compared with expansion with clear aligner.
| Arm | Type | Receives |
|---|---|---|
| Conventional expander | Active comparator | Device: Conventional expanderExpansion using conventional orthodontic expander(hyrax) |
| Invisalign | Experimental | Device: InvisalignExpansion with Invisalign appliance |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age (12-16)
- Good oral hygiene
- Constricted maxilla or moderate crowding
Key exclusion criteria (3 listed)
- Patient receive drugs
- Periodontal diseas
- Past 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 |
|---|---|---|
| InvisalignAlso: HyraxExpansion using Invisalign versus conventional expander | Device | Invisalign |
| Conventional expanderconventional expander | Device | Conventional expander |
Primary outcome
Linear amount of midpalatal Suture opening
Time frame: 4 months
Apperance of Distema , calculate the amount of general space
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Expansion of Maxillary Arch
Not yet recruiting
Comparison of Maxillary Dental Expansion Using Smartee Clear Aligner With and Without S11 Expander: A Randomized Clinical Trial
Crossbite (Posterior), Expansion of Maxillary Arch
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.
Saleh A Saleh, Professor study director
Al-Azhar University
Mohamad A Salem, Professor study director
Al-Azhar University
Mohsena A Abdarrazik, Lecturer study director
Al-Azhar University
Questions about this trial
What is this clinical trial studying?
A study testing Invisalign and Conventional expander in people with Expansion of Maxillary Arch and Maxillary Hypoplasia, run by Al-Azhar University.
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 3 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 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Amro S Ibrahim (+201002125687, amrIbrahim.209@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear amount of midpalatal Suture opening (time frame: 4 months). 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 13 Jun 2023.