Malocclusion, Angle Class INCT03129919
Arch Dimension and Inclination of the Upper and Lower Incisors Changes
A study testing Carriere SLX® (Passive self-ligating braces) and Empower® (Interactive self-ligating braces) in people with Malocclusion, Angle Class I, run by Fundación Universitaria CIEO.
Trial summary
It is intended to evaluate changes in arch dimensions and incisor inclination as well as changes in the WALA Ridge in no extraction patients treated with interactive self-ligating brackets (Empower®) and passive (Carriere SLX®) at the end of the phase of alignment and leveling. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Malocclusion, Angle Class I
- What is being tested?
- Carriere SLX® (Passive self-ligating braces) and Empower® (Interactive self-ligating braces)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2017to 1 Apr 2018
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Complete permanent dentition, except third molars.
- Class I malocclusion, determined by Angle ANB 2 plus or minus 2
- Visible alveolar teeth and ridges in plaster models, the latter being compatible and checked against the morphology of the WALA Ridge clinically presented by the patient.
- Little index with minimum Irregularity 4-6 mm.
- Patients with x-rays of initial profile and at the end of alignment and leveling in good condition.
Who cannot join
- Models in poor condition that do not allow measurements.
- Patients who do not wish to participate in the study
- Patients with cleft lip and palate
- Patients with craniofacial anomalies
- Patients with previous orthodontic treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Arch Dimension and Inclination of the Upper and Lower Incisors Changes in Patients Treated With Interactive and Passive Self-ligation Brackets
It is intended to evaluate changes in arch dimensions and incisor inclination as well as changes in the WALA Ridge in no extraction patients treated with interactive self-ligating brackets (Empower®) and passive (Carriere SLX®) at the end of the phase of alignment and leveling. For this, study models and profile radiographs taken before the start of treatment and at the end of the alignment and leveling phase will be evaluated. The parameters to be measured are: intercanine distance, arch depth, upper and lower incisor inclination, and WALA ridge analysis
- Conditions
- Malocclusion, Angle Class I
- Being tested
- Carriere SLX® (Passive self-ligating braces), Empower® (Interactive self-ligating braces)
- Medical subject headings
- Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carriere SLX® (Passive self-ligating braces)Device
Changes in the inclination of the incisors, expansion of the arches at the end of the alignment and leveling phase of the orthodontic treatment
Empower® (Interactive self-ligating braces)Device
Changes in the inclination of the incisors, expansion of the arches at the end of the alignment and leveling phase of the orthodontic treatment
| Study group | Role | What they receive |
|---|---|---|
| Orthodontic patients treated with brackets Carriere SLX® | Experimental | Subjects requiring orthodontic treatment and will be treated with passive self-ligating braces Carriere SLX® Receives: Device: Carriere SLX® (Passive self-ligating braces) |
| Orthodontic patients treated with brackets Empower® | Active comparator | Subjects requiring orthodontic treatment and will be treated with interactive self-ligating braces Empower® Receives: Device: Empower® (Interactive self-ligating braces) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisomaxillary angle
Angle formed by the palatal plane and the upper incisor
Measured: At the end of the alignment and leveling phase, an average of 8 months
Secondary outcomes (2)
Transverse development of the upper and lower jaws
Cuspal and basal intercanine distance
Measured: Each time wire is changed in the sequence suggested by the author, an average of 3 months
Inclination of the lower incisor
Incisal mandibular plane angle
Measured: At the end of the alignment and leveling phase, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start15 May 2017 (estimated)
- Primary completion1 Apr 2018 (estimated)
- Study completion1 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria CIEO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Vivian Forero Manrique, Fundación Universitaria CIEO
- Investigators
- Claudia Forero, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129919
- Sponsor's protocol ID
- 0001
- Status last verified
- Apr 2017
- First submitted
- 22 Mar 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- 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 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arch Dimension and Inclination of the Upper and Lower Incisors Changes in Patients Treated With Interactive and Passive Self-ligation Brackets
- ClinicalTrials.gov ID
- NCT03129919
- Acronym / sponsor ID
- 0001
- Conditions
- Malocclusion, Angle Class I
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundación Universitaria CIEOUniversity, hospital or other
- Study start
- 15 May 2017 (estimated)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 26 Apr 2017 (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.
It is intended to evaluate changes in arch dimensions and incisor inclination as well as changes in the WALA Ridge in no extraction patients treated with interactive self-ligating brackets (Empower®) and passive (Carriere SLX®) at the end of the phase of alignment and leveling. For this, study models and profile radiographs taken before the start of treatment and at the end of the alignment and leveling phase will be evaluated. The parameters to be measured are: intercanine distance, arch depth, upper and lower incisor inclination, and WALA ridge analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthodontic patients treated with brackets Carriere SLX® | Experimental | Device: Carriere SLX® (Passive self-ligating braces)Subjects requiring orthodontic treatment and will be treated with passive self-ligating braces Carriere SLX® |
| Orthodontic patients treated with brackets Empower® | Active comparator | Device: Empower® (Interactive self-ligating braces)Subjects requiring orthodontic treatment and will be treated with interactive self-ligating braces Empower® |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Complete permanent dentition, except third molars.
- Class I malocclusion, determined by Angle ANB 2 plus or minus 2
- Visible alveolar teeth and ridges in plaster models, the latter being compatible and checked against the morphology of the WALA Ridge clinically presented by the patient.
- Little index with minimum Irregularity 4-6 mm.
- Patients with x-rays of initial profile and at the end of alignment and leveling in good condition.
Key exclusion criteria (5 listed)
- Models in poor condition that do not allow measurements.
- Patients who do not wish to participate in the study
- Patients with cleft lip and palate
- Patients with craniofacial anomalies
- Patients with previous orthodontic treatment
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 |
|---|---|---|
| Carriere SLX® (Passive self-ligating braces)Changes in the inclination of the incisors, expansion of the arches at the end of the alignment and leveling phase of the orthodontic treatment | Device | Orthodontic patients treated with brackets Carriere SLX® |
| Empower® (Interactive self-ligating braces)Changes in the inclination of the incisors, expansion of the arches at the end of the alignment and leveling phase of the orthodontic treatment | Device | Orthodontic patients treated with brackets Empower® |
Primary outcome
Incisomaxillary angle
Time frame: At the end of the alignment and leveling phase, an average of 8 months
Angle formed by the palatal plane and the upper incisor
2 secondary outcomes
Transverse development of the upper and lower jaws
Time frame: Each time wire is changed in the sequence suggested by the author, an average of 3 months
Inclination of the lower incisor
Time frame: At the end of the alignment and leveling phase, an average of 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Claudia Forero principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing Carriere SLX® (Passive self-ligating braces) and Empower® (Interactive self-ligating braces) in people with Malocclusion, Angle Class I, run by Fundación Universitaria CIEO.
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 5 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 26 Apr 2017. 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?
Contact CLAUDIA FORERO (57-1-7437919, claudiavivian@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisomaxillary angle (time frame: At the end of the alignment and leveling phase, an average of 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 26 Apr 2017.