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

NCT03363620 | Completed Phase 3

• 1 other identifier: CES101
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Orthodontic Appliance Complication

Keywords

maxillary expansion; self ligating; arch form

Outcome Measures

Primary Outcomes (1)

• transverse development of the arches

  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 Outcomes (1)

• incisor inclination

  2 years

Study Arms (2)

self ligation brackets damon ormco®

EXPERIMENTAL

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

conventional brackets orthos ormco®

ACTIVE COMPARATOR

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

Interventions

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

Also known as: self ligation brackets

self ligation brackets damon ormco®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• CES University: lead

Related Publications (2)

• 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.

  PMID: 27241993 BACKGROUND

• 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.

  PMID: 23910199 RESULT

MeSH Terms

Interventions

Orthodontic Brackets

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, Fixed; Orthodontic Appliances; Orthodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ORTHODONTIST

Study Record Dates

• First Submitted: November 4, 2017
• First Posted: December 6, 2017
• Study Start: January 20, 2015
• Primary Completion: December 20, 2015
• Study Completion: December 20, 2016
• Last Updated: December 6, 2017

Record last verified: 2017-12