Orthodontic AlignersNCT06231875
Difference Between Pressing and Vacuum Techniques in Fabrication of Orthodontic Aligners in Cases With Spacing: A Cross-sectional Study
An observational study of Orthodontic Aligners, run by Cairo University at 1 site in Egypt.
Trial summary
This cross sectional study is aiming to compare 2 techniques of clear aligners fabrication identifying which is better. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Aligners
- What is being tested?
- Press
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 30 May 2024
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult patient with maxillary moderate spacing.
Who may be able to join
- Maxillary arch with moderate spacing.
- Full permenant dentition.
Who cannot join
- Missing teeth.
- Any restorations.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Cairo, 00202
Mohamed Abd-El-Ghafour, PhD, +2 01007433288, mabdelghafour@dentistry.cu.edu.eg
Marwan AT Awad, BDS, +201277782224, marwanawad95@gmail.com
About this study
This cross sectional study is aiming to compare 2 techniques of clear aligners fabrication identifying which is better.
- Conditions
- Orthodontic Aligners
- Being tested
- Press
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PressDevice
Fabrication of clear aligners using press machine (Mini-star)
| Study group | Role | What they receive |
|---|---|---|
| Press | Not described Receives: Device: Press | |
| Vacuum | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary arch dimensions
Arch lengths, Arch widths and each tooth size will be measured and compared between the 2 groups.
Measured: 6 months
Secondary outcomes (1)
Model superimposition
Superimposition of the models from the 2 groups will be done and then map difference will be measured.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic AlignersStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd El-Ghafour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231875
- Sponsor's protocol ID
- 004
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference Between Pressing and Vacuum Techniques in Fabrication of Orthodontic Aligners in Cases With Spacing: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06231875
- Acronym / sponsor ID
- 004
- Conditions
- Orthodontic Aligners
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 30 Jan 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 cross sectional study is aiming to compare 2 techniques of clear aligners fabrication identifying which is better.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Press | – | Device: Press |
| Vacuum | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patient with maxillary moderate spacing.
Key inclusion criteria (2 listed)
- Maxillary arch with moderate spacing.
- Full permenant dentition.
Key exclusion criteria (2 listed)
- Missing teeth.
- Any restorations.
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 |
|---|---|---|
| PressFabrication of clear aligners using press machine (Mini-star) | Device | Press |
Primary outcome
Maxillary arch dimensions
Time frame: 6 months
Arch lengths, Arch widths and each tooth size will be measured and compared between the 2 groups.
1 secondary outcome
Model superimposition
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Orthodontic Aligners
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Periodontal Health in Adults Treated With Fixed Orthodontic Appliances or Clear Aligners
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Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
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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?
An observational study of Orthodontic Aligners, 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 2 inclusion and 2 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 30 Jan 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxillary arch dimensions (time frame: 6 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 30 Jan 2024.