Status unknownNCT03129919Updated Apr 26, 2017

Arch Dimension and Inclination of the Upper and Lower Incisors Changes

An interventional study of Carriere SLX® (Passive self-ligating braces) and Empower® (Interactive self-ligating braces) in Malocclusion, Angle Class I, sponsored by Fundación Universitaria CIEO. Status unknown. Open to participants aged 16 Years to 35 Years. Per ClinicalTrials.gov, last updated 2017-04-26.

Sponsored by Fundación Universitaria CIEO · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 16 Years to 35 Years
Sex: All

Study 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. 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 studied

Malocclusion, Angle Class I

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Malocclusion, Angle Class I 35

In context

Malocclusion, Angle Class I

35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.

This study's planned enrollment of 60 is above the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.

Browse Malocclusion, Angle Class I studies →

Lead sponsor

Fundación Universitaria CIEO is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 16 Years to 35 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 60 participants (estimated)

Study arms

Experimental
Orthodontic patients treated with brackets Carriere SLX®
Subjects requiring orthodontic treatment and will be treated with passive self-ligating braces Carriere SLX®
Device: Carriere SLX® (Passive self-ligating braces)
Active comparator
Orthodontic patients treated with brackets Empower®
Subjects requiring orthodontic treatment and will be treated with interactive self-ligating braces Empower®
Device: Empower® (Interactive self-ligating braces)

Interventions

DeviceCarriere 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
DeviceEmpower® (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

What researchers measure

Primary outcomes

Incisomaxillary angle
Angle formed by the palatal plane and the upper incisor
Time frame: At the end of the alignment and leveling phase, an average of 8 months

Secondary outcomes

Transverse development of the upper and lower jaws
Cuspal and basal intercanine distance
Time frame: 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
Time frame: At the end of the alignment and leveling phase, an average of 8 months

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2017; primary completion for Apr 2018, 10 months later.

Of 23 interventional studies with no phase under Malocclusion, Angle Class I, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 24. This study's planned 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 22, 2017
First posted: Apr 26, 2017
StartEst.: May 15, 2017
Primary completionEst.: Apr 1, 2018
CompletionEst.: Apr 1, 2018
Last update: Apr 26, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03129919
Lead sponsor: Fundación Universitaria CIEO
Responsible party: Claudia Vivian Forero Manrique (Self-ligating clinical professor, Fundación Universitaria CIEO) — Principal investigator
First posted: Apr 26, 2017
Start date: May 15, 2017 (estimated)
Primary completion: Apr 1, 2018 (estimated)
Completion: Apr 1, 2018 (estimated)
Last update: Apr 26, 2017

Study contacts

CLAUDIA FORERO

Contact

claudiavivian@gmail.com

57-1-7437919

Claudia Forero

principal investigator

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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