- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03363620
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
Conditions
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:
- 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
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:
|
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:
|
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.
General Publications
- Atik E, Akarsu-Guven B, Kocadereli I, Ciger S. Evaluation of maxillary arch dimensional and inclination changes with self-ligating and conventional brackets using broad archwires. Am J Orthod Dentofacial Orthop. 2016 Jun;149(6):830-7. doi: 10.1016/j.ajodo.2015.11.024.
- Fleming PS, Lee RT, Marinho V, Johal A. Comparison of maxillary arch dimensional changes with passive and active self-ligation and conventional brackets in the permanent dentition: a multicenter, randomized controlled trial. Am J Orthod Dentofacial Orthop. 2013 Aug;144(2):185-93. doi: 10.1016/j.ajodo.2013.03.012.
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
Keywords
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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