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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363620
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
ANGELA MARIA SIERRA ANGEL, CES University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Orthodontic Appliance Complication Device: Orthodontic Brackets Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 20, 2015
Actual Primary Completion Date : December 20, 2015
Actual Study Completion Date : December 20, 2016

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.
Device: Orthodontic Brackets
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 Name: self ligation 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.
Device: Orthodontic Brackets
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 Name: conventional brackets




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Publications of Results:
Other Publications:
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Responsible Party: ANGELA MARIA SIERRA ANGEL, ORTHODONTIST, CES University
ClinicalTrials.gov Identifier: NCT03363620    
Other Study ID Numbers: CES101
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ANGELA MARIA SIERRA ANGEL, CES University:
maxillary expansion
self ligating
arch form