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

December 5, 2017 updated by: ANGELA MARIA SIERRA ANGEL, CES University

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: self ligation brackets damon ormco®
the self ligation bracket (damon system) in the orthodontic treatment, was used in the experimental group with the recommended protocol damon arches sequence.
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:
  • conventional brackets
Active Comparator: conventional brackets orthos ormco®
the conventional bracket (orthos system) in the orthodontic treatment, was used in the active comparator group with the recommended protocol damon arches sequence as used in the experimental group.
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:
  • conventional brackets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2015

Primary Completion (Actual)

December 20, 2015

Study Completion (Actual)

December 20, 2016

Study Registration Dates

First Submitted

November 4, 2017

First Submitted That Met QC Criteria

December 5, 2017

First Posted (Actual)

December 6, 2017

Study Record Updates

Last Update Posted (Actual)

December 6, 2017

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • CES101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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