Root ResorptionNCT05232318
Root Resorption Accompanied Clear Aligners and Fixed Orthodontic Appliance
A study testing Leveling and alignment in people with Root Resorption, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
The aim of the study is to compare apical root resorption accompanied orthodontic treatment using clear aligners vs fixed appliances. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Resorption
- What is being tested?
- Leveling and alignment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Apr 2022to 1 Apr 2023
- 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy systemic condition/no systemic illness, as reported by patients.
- No use any form of anti - inflammatory drugs the at beginning of study.
- Good oral hygiene.
- Cooperative and motivated.
- In the permanent dentition with all teeth present ( except third molars).
- Minimum to moderate anterior crowding.
- No previous orthodontic treatment.
Who cannot join
- Previous upper removable orthodontic treatment.
- Patients who required surgery to correct skeletal discrepancies.
- Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate).
- Uncooperative patients.
- Patients with poor oral hygiene.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
AlAzhar Azhar University
Cairo, Or
AlAzhar A University, +201001405584, Dent.b.dean@azhar.edu.eg
- Not yet recruiting
Al Azhar university
Cairo
AlAzhar University, +201001405584, Dent.b.dean@azhar.edu.eg
About this study
Official title: Apical Root Resorption Accompanied Orthodontic Treatment Using Clear Aligners Versus Fixed Appliances: A CBCT Comparative Study
The aim of the study is to compare apical root resorption accompanied orthodontic treatment using clear aligners vs fixed appliances.
Read the detailed description
by using pretreatment and posttreatment CBCT, root resorption will be measured using a 3D imaging software.
- Conditions
- Root Resorption
- Being tested
- Leveling and alignment
- Medical subject headings
- Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leveling and alignmentOther
Root resorption comparison through the use of CBCT
| Study group | Role | What they receive |
|---|---|---|
| leveling and alignment using fixed orthodontic appliance | Active comparator | leveling and alignment using fixed orthodontic appliance Receives: Other: Leveling and alignment |
| leveling and alignment using clear aligner | Experimental | leveling and alignment using clear aligner Receives: Other: Leveling and alignment |
| leveling and alignment using clear aligner with low level laser therapy | Experimental | leveling and alignment using clear aligner with low level laser therapy Receives: Other: Leveling and alignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Root resorption
Using pretreatment and posttreatment CBCT, volumetric root resorption will be measured by using 3D imaging software
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Apr 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root ResorptionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Obaida Khaleel Ibrahim, Al-Azhar University
- Investigators
- Ahmed M Abouelnour, Lecturer, Study director, Lecturer, Department of OrthodonticsRamadan Y Aboushahba, Associate professor, Study chair, Associate professor, Department of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232318
- Sponsor's protocol ID
- 357/1150
- Status last verified
- Jan 2023
- First submitted
- 18 Dec 2021
- Last updated
- 10 Jan 2023
- Results posted
- 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 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apical Root Resorption Accompanied Orthodontic Treatment Using Clear Aligners Versus Fixed Appliances: A CBCT Comparative Study
- ClinicalTrials.gov ID
- NCT05232318
- Acronym / sponsor ID
- 357/1150
- Conditions
- Root Resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 9 Feb 2022 (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.
The aim of the study is to compare apical root resorption accompanied orthodontic treatment using clear aligners vs fixed appliances.
Detailed description
by using pretreatment and posttreatment CBCT, root resorption will be measured using a 3D imaging software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| leveling and alignment using fixed orthodontic appliance | Active comparator | Other: Leveling and alignmentleveling and alignment using fixed orthodontic appliance |
| leveling and alignment using clear aligner | Experimental | Other: Leveling and alignmentleveling and alignment using clear aligner |
| leveling and alignment using clear aligner with low level laser therapy | Experimental | Other: Leveling and alignmentleveling and alignment using clear aligner with low level laser therapy |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Healthy systemic condition/no systemic illness, as reported by patients.
- No use any form of anti - inflammatory drugs the at beginning of study.
- Good oral hygiene.
- Cooperative and motivated.
- In the permanent dentition with all teeth present ( except third molars).
Key exclusion criteria (5 listed)
- Previous upper removable orthodontic treatment.
- Patients who required surgery to correct skeletal discrepancies.
- Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate).
- Uncooperative patients.
- Patients with poor oral hygiene.
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 |
|---|---|---|
| Leveling and alignmentRoot resorption comparison through the use of CBCT | Other | leveling and alignment using clear aligner, leveling and alignment using clear aligner with low level laser therapy, leveling and alignment using fixed orthodontic appliance |
Primary outcome
Amount of Root resorption
Time frame: 8 months
Using pretreatment and posttreatment CBCT, volumetric root resorption will be measured by using 3D imaging software
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: No
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Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
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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.
Ahmed M Abouelnour, Lecturer study director
Lecturer, Department of Orthodontics
Ramadan Y Aboushahba, Associate professor study chair
Associate professor, Department of Orthodontics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leveling and alignment in people with Root Resorption, run by Al-Azhar University 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 7 inclusion and 5 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 10 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Obaida K Eldlemy (+201111488819, ObaidaKhalil.209@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Root resorption (time frame: 8 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 10 Jan 2023.