Crowding, Tooth, Class INCT05333094
Comparison Between the Effectiveness of Different Commercial Bracket Brands
A study testing Brackets in people with Crowding, Tooth, Class I, run by Future University in Egypt at 1 site in Egypt.
Trial summary
There's a scarcity in literature concerning the comparison of the effectiveness of brackets in its torque and tip ability, the time takes for leveling and alignment comparing between different orthodontic bracket brands, and its effect on the rate of tooth movement. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Crowding, Tooth, Class I
- What is being tested?
- Brackets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Dec 2022
- 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient with full set of permanent teeth
- Male and female (14-19 years old).
- Positive patients' acceptance for the study
- Patients have no history of previous orthodontic treatment.
Who cannot join
- Patients with enamel or dentin defect or any teeth anomaly will be eliminated.
- Patients having canine or lateral incisors peg shaped will be excluded from the research. - Medically compromised patients
- Patients unable to give an informed consent
- Patient with periodontal disease
- Patient taking long term medication
- Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth Breathing)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Future University In Egypt
Cairo
Leena Alaa, +201123880046
About this study
Official title: Comparison Between the Effectiveness of Different Commercial Bracket Brands, Having Roth Prescription and 0.022" Bracket Slot: A Randomized Clinical Trial
There's a scarcity in literature concerning the comparison of the effectiveness of brackets in its torque and tip ability, the time takes for leveling and alignment comparing between different orthodontic bracket brands, and its effect on the rate of tooth movement. The purpose of this study is to determine, In orthodontic patients with Class I molar relation and teeth crowding, in which different bracket brands will be compared.
Read the detailed description
Bracket effectiveness can be measured in a variety of ways, including torque, tip, time required for levelling and alignment, bracket failure, and the patient's visual analogue scale. All are viable options; therefore, we want to complete the orthodontic treatment and determine which brackets fulfilled the built-in bracket prescription and achieved success in terms of aesthetics, better smiles, better patient judgement, and function.
- Conditions
- Crowding, Tooth, Class I
- Being tested
- Brackets
- Keywords
- orthodontic bracket brands, torque prescription, tip prescription, levelling and Alignment, Lateral Cephalometric Radiographs, CBCT, VAS
- Medical subject headings
- Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BracketsOther
Levelling and alignment for the bonded teeth through following the wire sequence: 0.014 NiTi, 16 NiTi, 0.016×0.022 NiTi and 0.017×0.025 StSt. (Wires from American Orthodontics)
- After levelling and aligning is completed the patient will be referred for the uptake of post intervention records; a standardized dental photograph and CBCT after 6- 9 months)
| Study group | Role | What they receive |
|---|---|---|
| American orthodontics brackets | Active comparator | Roth prescription, 0.022" slot size Receives: Other: Brackets |
| FANTA brackets | Active comparator | Roth prescription, 0.022" slot size Receives: Other: Brackets |
| MATT brackets | Active comparator | Roth prescription, 0.022" slot size Receives: Other: Brackets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tip
The principle investigator will examine pre and post CBCT radiographs in relation to lines and reference planes (measurements in degrees and mm)
Measured: From pre to post levelling and alignment (an average of 6 - 8 months)
torque
The principle investigator will examine pre and post CBCT radiographs in relation to lines and reference planes (measurements in degrees and mm)
Measured: 3 months after reaching 19x25 stainless steel wire (an average of 6 - 8 months)
Secondary outcomes (1)
Levelling and alignment
The incisal edges of the anterior teeth and the buccal cusps of the posterior teeth are placed on the same horizontal level; and alignment is the lining up of teeth of an arch in order to achieve normal contact point relationships will be assessed by measuring Little's Irregularity Index (LII) using study models taken of the patients (measured in mm)
Measured: upto 6 months from the start of orthodontic treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 Dec 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crowding, Tooth, Class IStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Khaled Kamal Yacoub, Future University in Egypt
- Investigators
- Yehya A. Mostafa, Professor and Chairman, Study director, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333094
- Sponsor's protocol ID
- FUE.REC(32)/12-2020
- Status last verified
- Apr 2022
- First submitted
- 11 Apr 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effectiveness of Different Commercial Bracket Brands, Having Roth Prescription and 0.022" Bracket Slot: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05333094
- Acronym / sponsor ID
- FUE.REC(32)/12-2020
- Conditions
- Crowding, Tooth, Class I
- Keywords
- orthodontic bracket brands, torque prescription, tip prescription, levelling and Alignment, Lateral Cephalometric Radiographs, CBCT, VAS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 18 Apr 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.
There's a scarcity in literature concerning the comparison of the effectiveness of brackets in its torque and tip ability, the time takes for leveling and alignment comparing between different orthodontic bracket brands, and its effect on the rate of tooth movement. The purpose of this study is to determine, In orthodontic patients with Class I molar relation and teeth crowding, in which different bracket brands will be compared.
Detailed description
Bracket effectiveness can be measured in a variety of ways, including torque, tip, time required for levelling and alignment, bracket failure, and the patient's visual analogue scale. All are viable options; therefore, we want to complete the orthodontic treatment and determine which brackets fulfilled the built-in bracket prescription and achieved success in terms of aesthetics, better smiles, better patient judgement, and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| American orthodontics brackets | Active comparator | Other: BracketsRoth prescription, 0.022" slot size |
| FANTA brackets | Active comparator | Other: BracketsRoth prescription, 0.022" slot size |
| MATT brackets | Active comparator | Other: BracketsRoth prescription, 0.022" slot size |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patient with full set of permanent teeth
- Male and female (14-19 years old).
- Positive patients' acceptance for the study
- Patients have no history of previous orthodontic treatment.
Key exclusion criteria (6 listed)
- Patients with enamel or dentin defect or any teeth anomaly will be eliminated.
- Patients having canine or lateral incisors peg shaped will be excluded from the research. - Medically compromised patients
- Patients unable to give an informed consent
- Patient with periodontal disease
- Patient taking long term medication
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 |
|---|---|---|
| BracketsLevelling and alignment for the bonded teeth through following the wire sequence: 0.014 NiTi, 16 NiTi, 0.016×0.022 NiTi and 0.017×0.025 StSt. (Wires from American Orthodontics) • After levelling and aligning is completed the patient will be referred for the uptake of post intervention records; a standardized dental photograph and CBCT after 6- 9 months) | Other | American orthodontics brackets, FANTA brackets, MATT brackets |
Primary outcome
Tip
Time frame: From pre to post levelling and alignment (an average of 6 - 8 months)
The principle investigator will examine pre and post CBCT radiographs in relation to lines and reference planes (measurements in degrees and mm)
torque
Time frame: 3 months after reaching 19x25 stainless steel wire (an average of 6 - 8 months)
The principle investigator will examine pre and post CBCT radiographs in relation to lines and reference planes (measurements in degrees and mm)
1 secondary outcome
Levelling and alignment
Time frame: upto 6 months from the start of orthodontic treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: Yes. All Collected IPD
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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.
Yehya A. Mostafa, Professor and Chairman study director
Future University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brackets in people with Crowding, Tooth, Class I, run by Future University in Egypt 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 6 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 18 Apr 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?
Contact Salma K. Yacoub (01119174379 ext. +20, 20183314@fue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tip (time frame: From pre to post levelling and alignment (an average of 6 - 8 months)). The study lists 2 primary outcomes in all. 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 18 Apr 2022.