Arch Dimension and Inclination of the Upper and Lower Incisors Changes

Malocclusion, Angle Class I Clinical Trial

Official title:

Arch Dimension and Inclination of the Upper and Lower Incisors Changes in Patients Treated With Interactive and Passive Self-ligation Brackets

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03129919
• Other study ID #: 0001
• Status: Not yet recruiting
• Phase: N/A
• First received: March 22, 2017
• Last updated: April 25, 2017
• Start date: May 15, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: April 2017
• Source: Fundación Universitaria CIEO
• Contact: CLAUDIA FORERO
• Phone: 57-1-7437919
• Email: claudiavivian[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class I

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Universitaria CIEO

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incisomaxillary angle	Angle formed by the palatal plane and the upper incisor	At the end of the alignment and leveling phase, an average of 8 months
Secondary	Transverse development of the upper and lower jaws	Cuspal and basal intercanine distance	Each time wire is changed in the sequence suggested by the author, an average of 3 months
Secondary	Inclination of the lower incisor	Incisal mandibular plane angle	At the end of the alignment and leveling phase, an average of 8 months