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

NCT ID: NCT03363620

Last Updated: 2017-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-20
• Study Completion Date: 2016-12-20

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.

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.

Conditions

Orthodontic Appliance Complication

Keywords

maxillary expansion; self ligating; arch form

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Orthodontic Brackets

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Orthodontic Brackets

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

self ligation brackets; conventional brackets

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CES University

OTHER

Sponsor Role: lead

Responsible Party

ANGELA MARIA SIERRA ANGEL

ORTHODONTIST

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 27241993 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23910199 (View on PubMed)

Other Identifiers

CES101

Identifier Type: -

Identifier Source: org_study_id