Leveling and Alignment of TeethNCT04106141
Effect of Changing the Activation Frequency of the Arch Wires on the Rate of Leveling and Alignment in Moderate Crowding Cases
A study testing 6 weeks changing of archwire and 4 weeks changing of archwire in people with Leveling and Alignment of Teeth, run by Cairo University.
Trial summary
Leveling and alignment is the first stage in the orthodontic treatment, performed for every patient .The archwire are usually changed every 4 weeks for reactivation of the force on the teeth. However, this means that large number of appointments and archwires are required. Read more about this study
- Who is it for?
- Ages 18 to 33 years
- Conditions the study is for
- Leveling and Alignment of Teeth
- What is being tested?
- 6 weeks changing of archwire and 4 weeks changing of archwire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 9 Nov 2021
- 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 33 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged (18~33)
- CVMI = 6
- Moderate crowding (4-8) as described by Laura mitchel
- No extractions required
Who cannot join
- Growing patients
- Previous orthodontic treatment
- Missing teeth other than the wisdoms
About this study
Leveling and alignment is the first stage in the orthodontic treatment, performed for every patient .The archwire are usually changed every 4 weeks for reactivation of the force on the teeth. However, this means that large number of appointments and archwires are required. On the other hand, there is a lack of evidence that less number of appointments with longer time intervals between the visits and less number of wires will give the same effect.
- Conditions
- Leveling and Alignment of Teeth
- Being tested
- 6 weeks changing of archwire, 4 weeks changing of archwire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 weeks changing of archwireOther
changing the archwire after 6 weeks instead of 4 weeks
4 weeks changing of archwireOther
changing the archwire every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Not described Receives: Other: 4 weeks changing of archwire |
| intervention group | Active comparator | Not described Receives: Other: 6 weeks changing of archwire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of alignment of teeth
the teeth are aligned together by using Little irregularity index to measure the decrease in the discrepency in each digital model taken after changing of the wire
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Jan 2020 (estimated)
- Primary completion4 Sep 2021 (estimated)
- Study completion9 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leveling and Alignment of TeethStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seif-Allah Ahmed Sherif Nasr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106141
- Sponsor's protocol ID
- ORTH 3-3-4
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2019
- Last updated
- 26 Sep 2019
- 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 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Changing the Activation Frequency of the Arch Wires on the Rate of Leveling and Alignment in Moderate Crowding Cases
- ClinicalTrials.gov ID
- NCT04106141
- Acronym / sponsor ID
- ORTH 3-3-4
- Conditions
- Leveling and Alignment of Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 4 Sep 2021 (estimated)
- Study completion
- 9 Nov 2021 (estimated)
- First posted
- 26 Sep 2019 (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.
Leveling and alignment is the first stage in the orthodontic treatment, performed for every patient .The archwire are usually changed every 4 weeks for reactivation of the force on the teeth. However, this means that large number of appointments and archwires are required. On the other hand, there is a lack of evidence that less number of appointments with longer time intervals between the visits and less number of wires will give the same effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: 4 weeks changing of archwire |
| intervention group | Active comparator | Other: 6 weeks changing of archwire |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patients aged (18~33)
- CVMI = 6
- Moderate crowding (4-8) as described by Laura mitchel
- No extractions required
Key exclusion criteria (3 listed)
- Growing patients
- Previous orthodontic treatment
- Missing teeth other than the wisdoms
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 |
|---|---|---|
| 6 weeks changing of archwirechanging the archwire after 6 weeks instead of 4 weeks | Other | intervention group |
| 4 weeks changing of archwirechanging the archwire every 4 weeks | Other | control group |
Primary outcome
Degree of alignment of teeth
Time frame: 5 months
the teeth are aligned together by using Little irregularity index to measure the decrease in the discrepency in each digital model taken after changing of the wire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
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Not yet recruiting
Clinical Evaluation of Zirconium Dioxide Nano-Coated Arch Wires
Malocclusion of Anterior Teeth
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 6 weeks changing of archwire and 4 weeks changing of archwire in people with Leveling and Alignment of Teeth, run by Cairo 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 4 inclusion and 3 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 26 Sep 2019. 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?
Degree of alignment of teeth (time frame: 5 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 26 Sep 2019.