Skip to main content
OpenTrials
Completed

NCT Number: NCT03363620

Comparison of Arch Expansion Changes Between Passive Self-ligating and Conventional Brackets

The purpose of this randomized controlled clinical trial was to compare the transverse development of the arches and the incisor inclination comparing two different ligating systems (SL vs CL) with the same arch form protocol (Damon arch form) and the same disarticulation protocols after the alignment and leveling period of non-extraction patients.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Materials and Methods: Fifty-four subjects were randomly with an electronic randomization program allocated to treatment with either a self-ligating bracket system (Damon Q-slot 0.022", Ormco Corp,) or a conventional bracket system (Orthos-slot 0.022", Ormco Corp). All patients were treated following the same protocol and arch wire sequence: 0.014-inch, 0.018-inch and 0.014x0.025-inch Damon copper nickel-titanium arch wires (Cu-NiTi; Ormco). Lateral cephalograms and study models, taken at prior to treatment (T0) and after alignment and levelling (T1), were used to compare the amount of arch expansion and incisor angulation changes that took place. In the analysis of results in a single observer analyzes the data blindly without knowing which group the patients belonged. Results: Models and cephalograms of the patients and both stages(T0-T1) were measured at the data were analyzed in STATA S.E. Treatment produce statistically significant increases in transverse arch dimensions especially in premolars maxillary (2.8-4.3mm) and mandibullary (2.0-4.2mm) of both group. The expansion in the maxillary arch was similar for both groups, but in the mandibular arch was greater in the self ligation group in about 2 mm more. Conclusions: The treatment with self ligation brackets produced more expansion in the mandibular arch than the conventional ligation brackets when used the same arch Damon protocols.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ANB angle between 0º- 5º
  • Systemically and periodontally healthy subjects not taking any medications.
  • Maxillary and/or mandibular irregularity index (canine-to-canine) between mild to moderate
  • A non-extraction treatment approach.
  • Permanent dentition with second molars erupted or in a functional eruptive phase.

Exclusion criteria

  • Systemically and periodontally compromise subjects and taking any medications. (2 ) subjects who did not want participate in the investigation

Treatment and study plan

Orthodontic Brackets

Device

arch form development in the orthodontic treatment with 2 different kind of ligation brackets with the same arches protocol in the leveling and alignment phase

Other names: self ligation brackets

Primary outcomes

  1. transverse development of the arches

    Time frame: 2 years

    The maxillary and mandibular widths were measured between the cusp tips of the canines, the buccal cusp tips of the first and second premolars and the mesio-buccal cusp tips of the first molars . They were measured using a digital caliper (Starrett 799A-6/150 Digital Caliper, Athol, Massachusetts, USA) positioned parallel to the occlusal plane.

Secondary outcomes

  1. incisor inclination

    Time frame: 2 years

    incisor inclination , the maxillary incisors were measured in the lateral cephalogram, relative to the cranial base (U1-SN) and the palatal plane (U1-PP); the mandibular incisor were related to the mandibular plane (L1/Go-Gn) and NB (L1-NB).

Sponsors and collaborators

Lead sponsor

CES University

Other

Registry information

Official study title

Comparison of Arch Expansion Changes Between Passive Self-ligating and Conventional Brackets With Broad Arches After Alignment and Levelling With the Same Arch Protocol: A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Dec 6, 2017
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.