Orthodontic Appliance ComplicationNCT05604612
Assessment of the Effectiveness of Corticision Combined by Selfligating Bracket System on the Acceleration of Orthodontic Tooth Movement; A Prospective Clinical Study
A study testing Corticision in people with Orthodontic Appliance Complication, run by Al-Azhar University.
Trial summary
the goal of this clinical trial is to assess the effectiveness of the corticision with self-ligating bracket system on the acceleration of orthodontic tooth movement.The main question it aims to answer is whether or not there would be an augmented effect by undergoing corticision with using self-ligating brackets… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Corticision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Dec 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Class I orthodontic patients with mild to moderate crowding of upper anterior segment (2-4 mm) All permanent teeth are erupted (3rd molar not included). Good oral and general health No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement No previous orthodontic treatment.
Who cannot join
- Orthodontic cases with severe crowding of upper anterior segment that require extraction treatment approach. Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment. Patients with untreated decay or endodontic lesion.
About this study
the goal of this clinical trial is to assess the effectiveness of the corticision with self-ligating bracket system on the acceleration of orthodontic tooth movement.The main question it aims to answer is whether or not there would be an augmented effect by undergoing corticision with using self-ligating brackets regarding the acceleration of orthodontic tooth movement.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Corticision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticisionProcedure or surgery
Incisions in the cortical plate of maxillary bone
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Procedure: Corticision |
| Active Comparator | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Little's Irregularity Index
crowding resolution
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazem Abd Elhafeez Abd Elkhalek, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604612
- Sponsor's protocol ID
- 721/271
- Status last verified
- Oct 2022
- First submitted
- 30 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of Corticision Combined by Selfligating Bracket System on the Acceleration of Orthodontic Tooth Movement; A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT05604612
- Acronym / sponsor ID
- 721/271
- Conditions
- Orthodontic Appliance Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 3 Nov 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 goal of this clinical trial is to assess the effectiveness of the corticision with self-ligating bracket system on the acceleration of orthodontic tooth movement.The main question it aims to answer is whether or not there would be an augmented effect by undergoing corticision with using self-ligating brackets regarding the acceleration of orthodontic tooth movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Corticision |
| Active Comparator | No intervention | – |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Class I orthodontic patients with mild to moderate crowding of upper anterior segment (2-4 mm) All permanent teeth are erupted (3rd molar not included). Good oral and general health No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement No previous orthodontic treatment.
Key exclusion criteria (1 listed)
- Orthodontic cases with severe crowding of upper anterior segment that require extraction treatment approach. Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment. Patients with untreated decay or endodontic lesion.
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 |
|---|---|---|
| CorticisionIncisions in the cortical plate of maxillary bone | Procedure or surgery | Experimental |
Primary outcome
Little's Irregularity Index
Time frame: two months
crowding resolution
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Corticision in people with Orthodontic Appliance Complication, 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 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: status not confirmed, as of the sponsor's last update on 3 Nov 2022. 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?
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?
Little's Irregularity Index (time frame: two 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 3 Nov 2022.