The Present Study Aimed to Evaluate Root Parallelism in Cases of Anterior Teeth Spacing Treated With Clear Aligner Versus Fixed Orthodontic AppliancesNCT06803940
Evaluation of Root Parallelism in Cases of Anterior Teeth Spacing Clear Aligner Versus Fixed Appliances
A study testing clear aligner and orthodontic treatment in people with The Present Study Aimed to Evaluate Root Parallelism in Cases of Anterior Teeth Spacing Treated With Clear Aligner Versus Fixed Orthodontic Appliances and Spacing Between Anterior Teeth, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
evaluate root parallelism in cases of anterior teeth spacing treated with clear aligner versus fixed orthodontic appliances Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- The Present Study Aimed to Evaluate Root Parallelism in Cases of Anterior Teeth Spacing Treated With Clear Aligner Versus Fixed Orthodontic Appliances, Spacing Between Anterior Teeth
- What is being tested?
- clear aligner and orthodontic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Nov 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 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Medical problems or craniofacial disorders known to affect bone remodeling.
- Congenital defect or deformed anterior teeth.
- Presence of chronic or acute periodontal disease.
- Radiographic evidence of bone loss.
- History of systemic disease.
- Previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Root Parallelism in Cases of Anterior Teeth Spacing Treated With Clear Aligner Versus Fixed Appliances
evaluate root parallelism in cases of anterior teeth spacing treated with clear aligner versus fixed orthodontic appliances
- Conditions
- The Present Study Aimed to Evaluate Root Parallelism in Cases of Anterior Teeth Spacing Treated With Clear Aligner Versus Fixed Orthodontic Appliances, Spacing Between Anterior Teeth
- Being tested
- clear aligner, orthodontic treatment
- Keywords
- Clear aligner, anterior spacing, root parallelism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clear alignerProcedure or surgery
closing of spacing in anterior teeth with clear aligner therapy
orthodontic treatmentProcedure or surgery
conventional fixed orthodontic appliance
| Study group | Role | What they receive |
|---|---|---|
| aligner | Experimental | intervention patient treated with clear aligner therapy Receives: Procedure: clear aligner |
| fixed appliance | Active comparator | patient treated with conventional appliance Receives: Procedure: orthodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
root parallelism
root angulation
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 posted31 Jan 2025
- Study start1 Apr 2023
- Primary completion15 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Present Study Aimed to Evaluate Root Parallelism in Cases of Anterior Teeth Spacing Treated With Clear Aligner Versus Fixed Orthodontic AppliancesStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amira Osama Elshall, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803940
- Sponsor's protocol ID
- P-OR-23-09
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Root Parallelism in Cases of Anterior Teeth Spacing Treated With Clear Aligner Versus Fixed Appliances
- ClinicalTrials.gov ID
- NCT06803940
- Acronym / sponsor ID
- P-OR-23-09
- Conditions
- The Present Study Aimed to Evaluate Root Parallelism in Cases of Anterior Teeth Spacing Treated With Clear Aligner Versus Fixed Orthodontic Appliances, Spacing Between Anterior Teeth
- Keywords
- Clear aligner, anterior spacing, root parallelism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 31 Jan 2025 (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.
evaluate root parallelism in cases of anterior teeth spacing treated with clear aligner versus fixed orthodontic appliances
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aligner | Experimental | Procedure: clear alignerintervention patient treated with clear aligner therapy |
| fixed appliance | Active comparator | Procedure: orthodontic treatmentpatient treated with conventional appliance |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Medical problems or craniofacial disorders known to affect bone remodeling.
- Congenital defect or deformed anterior teeth.
- Presence of chronic or acute periodontal disease.
- Radiographic evidence of bone loss.
- History of systemic disease.
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 |
|---|---|---|
| clear alignerclosing of spacing in anterior teeth with clear aligner therapy | Procedure or surgery | aligner |
| orthodontic treatmentconventional fixed orthodontic appliance | Procedure or surgery | fixed appliance |
Primary outcome
root parallelism
Time frame: 6 months
root angulation
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 31 Jan 2025.
- Individual participant dataSharing planned: Undecided
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 study testing clear aligner and orthodontic treatment in people with The Present Study Aimed to Evaluate Root Parallelism in Cases of Anterior Teeth Spacing Treated With Clear Aligner Versus Fixed Orthodontic Appliances and Spacing Between Anterior Teeth, run by Faculty of Dental Medicine for Girls 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 0 inclusion and 6 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 31 Jan 2025. 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?
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?
root parallelism (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 31 Jan 2025.