Moderate and Severe Crowding in Lower Dental ArchNCT05537506
Evaluation of Effects of Bracket's Slot System on the Quantity and Quality of Teeth Movements During Orthodontic Leveling and Alignment Stage
A study testing Bracket slot 0.018 and Bracket slot 0.022 in people with Moderate and Severe Crowding in Lower Dental Arch, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Evaluation of effect of bracket slot system on the quality and quantity of tooth movement during leveling and alignment stage Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate and Severe Crowding in Lower Dental Arch
- What is being tested?
- Bracket slot 0.018 and Bracket slot 0.022
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2023to 25 Oct 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- An age range from14 to18 years. All permanent teeth are erupted(3rd molar not included).
- Angle class I malocclusion with normal facial proportions.
- Moderate to severe crowding in the lower dental arch asassessed by lett irregularity Index that require treatment with fixed appliance using extraction approach.
- There is no previous orthodontic treatment.
Who cannot join
- Poor oral hygiene or periodontally compromised teeth.
- Craniofacial anomalies or previous history of trauma, bruxism, or Parafunctions.
- Uncooperativepatient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Effects of Bracket's Slot System on the Quantity and Quality of Teeth Movements During Orthodontic Leveling and Alignment Stage : A Prospective Clinical Study
Evaluation of effect of bracket slot system on the quality and quantity of tooth movement during leveling and alignment stage
- Being tested
- Bracket slot 0.018, Bracket slot 0.022
- Keywords
- Slot 0.018, Slot 0.022, Bracket, Leveling, Alignment
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bracket slot 0.018Device
That includes12 patients who will be treated using the bracket slot 0.018×0.025-inch system.
Bracket slot 0.022Device
Includes12 patients who will be treated using the bracket slot 0.022×0.028-inch system
| Study group | Role | What they receive |
|---|---|---|
| Bracket slot 0.018 | Active comparator | Not described Receives: Device: Bracket slot 0.018 |
| Bracket slot 0.022 | Active comparator | Not described Receives: Device: Bracket slot 0.022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of tooth movement by different bracket slot system
Amount of tooth movement
Measured: At 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start25 Jan 2023 (estimated)
- Primary completion25 Aug 2023 (estimated)
- Study completion25 Oct 2023 (estimated)
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 Moderate and Severe Crowding in Lower Dental ArchStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belal Abdelrahman Abdelmotaleb Elgohary, Al-Azhar University
- Investigators
- Alazhar University, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537506
- Sponsor's protocol ID
- 735/1246
- Status last verified
- Sep 2022
- First submitted
- 28 Aug 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mavragani M, Vergari A, Selliseth NJ, Boe OE, Wisth PL. A radiographic comparison of apical root resorption after orthodontic treatment with a standard edgewise and a straight-wire edgewise technique. Eur J Orthod. 2000 Dec;22(6):665-74. doi: 10.1093/ejo/22.6.665.
PubMed 11212602
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effects of Bracket's Slot System on the Quantity and Quality of Teeth Movements During Orthodontic Leveling and Alignment Stage : A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT05537506
- Acronym / sponsor ID
- 735/1246
- Keywords
- Slot 0.018, Slot 0.022, Bracket, Leveling, Alignment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 25 Jan 2023 (estimated)
- Primary completion
- 25 Aug 2023 (estimated)
- Study completion
- 25 Oct 2023 (estimated)
- First posted
- 13 Sep 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.
Evaluation of effect of bracket slot system on the quality and quantity of tooth movement during leveling and alignment stage
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bracket slot 0.018 | Active comparator | Device: Bracket slot 0.018 |
| Bracket slot 0.022 | Active comparator | Device: Bracket slot 0.022 |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- An age range from14 to18 years. All permanent teeth are erupted(3rd molar not included).
- Angle class I malocclusion with normal facial proportions.
- Moderate to severe crowding in the lower dental arch asassessed by lett irregularity Index that require treatment with fixed appliance using extraction approach.
- There is no previous orthodontic treatment.
Key exclusion criteria (3 listed)
- Poor oral hygiene or periodontally compromised teeth.
- Craniofacial anomalies or previous history of trauma, bruxism, or Parafunctions.
- Uncooperativepatient.
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 |
|---|---|---|
| Bracket slot 0.018That includes12 patients who will be treated using the bracket slot 0.018×0.025-inch system. | Device | Bracket slot 0.018 |
| Bracket slot 0.022Includes12 patients who will be treated using the bracket slot 0.022×0.028-inch system | Device | Bracket slot 0.022 |
Primary outcome
Rate of tooth movement by different bracket slot system
Time frame: At 8 months
Amount of tooth movement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Background: PubMed 11212602Mavragani M, Vergari A, Selliseth NJ, Boe OE, Wisth PL. A radiographic comparison of apical root resorption after orthodontic treatment with a standard edgewise and a straight-wire edgewise technique. Eur J Orthod. 2000 Dec;22(6):665-74. doi: 10.1093/ejo/22.6.665.
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.
Alazhar University principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bracket slot 0.018 and Bracket slot 0.022 in people with Moderate and Severe Crowding in Lower Dental Arch, run by Al-Azhar University 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 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 13 Sep 2022. 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?
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?
Rate of tooth movement by different bracket slot system (time frame: At 8 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 NCT05537506, 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 13 Sep 2022.