Pathological Resorption of External RootNCT06510569
3D Evaluation of Clear Aligners Versus Fixed Orthodontic Treatment of Lower Anterior Crowding
A study testing U lab aligners and oramco bracket in people with Pathological Resorption of External Root, run by Haidy Fekry at 2 sites in Egypt.
Trial summary
Evaluate and compare clear aligners versus fixed orthodontic treatment of lower anterior crowding with the use of cone-beam computed tomography within maximum 6 months or until correction of lower anterior crowding whichever is nearest to occur. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pathological Resorption of External Root
- What is being tested?
- U lab aligners and oramco bracket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Apr 2022to 1 Jun 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult female patients . age 18-25 y . Patients with mild to moderate lower anterior crowding (1 mm - 6 mm ) . Healthy compliant and motivated patient . full dentition except wisdom teeth .
Who cannot join
- Previous orthodontic treatments. Any systemic disease Pregnant and lactating female. pocket depth more than 5 mm.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Three-Dimensional Evaluation of Clear Aligners Versus Fixed Orthodontic Treatment of Lower Anterior Crowding: A Randomized Clinical Trial
Evaluate and compare clear aligners versus fixed orthodontic treatment of lower anterior crowding with the use of cone-beam computed tomography within maximum 6 months or until correction of lower anterior crowding whichever is nearest to occur.
Read the detailed description
Group (A): Patients will be treated with conventional fixed orthodontic treatment in lower anterior crowding.
Group (B): Patients will be treated with clear aligner therapy in lower anterior crowding.
- Conditions
- Pathological Resorption of External Root
- Being tested
- U lab aligners, oramco bracket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U lab alignersDevice
Aligner group change the aligner every 10 days
oramco bracketDevice
changing orthodontic wire every one month
| Study group | Role | What they receive |
|---|---|---|
| Clear aligner therapy | Experimental | U lab aligners Receives: Device: U lab aligners |
| Fixed orthodontic treatment | Experimental | Oromo bracket Receives: Device: oramco bracket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of lower anterior crowding
according to little irregularity index
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 posted19 Jul 2024
- Study start15 Apr 2022
- Primary completion10 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pathological Resorption of External RootStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haidy Fekry
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Haidy Fekry, Faculty of Dental Medicine for Girls
- Investigators
- samir A ibrahim, proffesor, Principal investigator, Al azhar universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510569
- Sponsor's protocol ID
- ORTHO-109-2-I
- Status last verified
- Jul 2024
- First submitted
- 20 Jun 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fiori A, Minervini G, Nucci L, d'Apuzzo F, Perillo L, Grassia V. Predictability of crowding resolution in clear aligner treatment. Prog Orthod. 2022 Nov 28;23(1):43. doi: 10.1186/s40510-022-00438-z.
PubMed 36437397
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Evaluation of Clear Aligners Versus Fixed Orthodontic Treatment of Lower Anterior Crowding: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06510569
- Acronym / sponsor ID
- ORTHO-109-2-I
- Conditions
- Pathological Resorption of External Root
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Haidy FekryOther government
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 19 Jul 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.
Evaluate and compare clear aligners versus fixed orthodontic treatment of lower anterior crowding with the use of cone-beam computed tomography within maximum 6 months or until correction of lower anterior crowding whichever is nearest to occur.
Detailed description
Group (A): Patients will be treated with conventional fixed orthodontic treatment in lower anterior crowding.
Group (B): Patients will be treated with clear aligner therapy in lower anterior crowding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clear aligner therapy | Experimental | Device: U lab alignersU lab aligners |
| Fixed orthodontic treatment | Experimental | Device: oramco bracketOromo bracket |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult female patients . age 18-25 y . Patients with mild to moderate lower anterior crowding (1 mm - 6 mm ) . Healthy compliant and motivated patient . full dentition except wisdom teeth .
Key exclusion criteria (1 listed)
- Previous orthodontic treatments. Any systemic disease Pregnant and lactating female. pocket depth more than 5 mm.
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 |
|---|---|---|
| U lab alignersAligner group change the aligner every 10 days | Device | Clear aligner therapy |
| oramco bracketchanging orthodontic wire every one month | Device | Fixed orthodontic treatment |
Primary outcome
Correction of lower anterior crowding
Time frame: 6 months
according to little irregularity index
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 19 Jul 2024.
- Results publication: PubMed 36437397Fiori A, Minervini G, Nucci L, d'Apuzzo F, Perillo L, Grassia V. Predictability of crowding resolution in clear aligner treatment. Prog Orthod. 2022 Nov 28;23(1):43. doi: 10.1186/s40510-022-00438-z.
- Predictability of crowding resolution in clear aligner treatmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Pathological Resorption of External Root
Not yet recruiting
Comparative Outcomes of Damon Ultima vs Pitts 21 Pro Bracket Systems
Orthodentic Appliances, Orthodontic Pathological Resorption of External Root
Active, not recruiting
Effect of Clear Aligner Wear Protocol on External Root Resorption
Clear Aligner Therapy
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.
samir A ibrahim, proffesor principal investigator
Al azhar universty
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing U lab aligners and oramco bracket in people with Pathological Resorption of External Root, run by Haidy Fekry at 2 sites 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 1 inclusion and 1 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 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Correction of lower anterior crowding (time frame: 6 months). 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 NCT06510569, which also lists 1 linked publication.
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 19 Jul 2024.