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Clinical Trials/NCT02084277
NCT02084277
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A Randomized Clinical Trial to Compare Oral Health Related Quality of Life Outcome for Patients With Malocclusion Receiving Orthodontic Treatment: Before Treatment vs. During Initial Treatment; Self-ligating Brackets vs. Conventional Brackets

Mackay Memorial Hospital1 site in 1 country120 target enrollmentJune 2010
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ConditionsMalocclusion

Overview

Phase
N/A
Intervention
Not specified
Conditions
Malocclusion
Sponsor
Mackay Memorial Hospital
Enrollment
120
Locations
1
Primary Endpoint
Patient Reported Outcome - Oral Health Related Quality of Life
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The objective of this prospective study is to compare these two treatments (conventional brackets v.s. self-ligating brackets) in malocclusion to determine which treatment will provide the better oral health related quality of life (OHRQoL) outcomes for patients during the initial orthodontic treatment compared with pretreatment.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
December 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Tai-ting Lai

Director of Orthodontic Department

Mackay Memorial Hospital

Eligibility Criteria

Inclusion Criteria

  • •malocclusion patients
  • •age between 12 to 40 years
  • •suitable for orthodontic treatment using either self-ligating brackets or conventional brackets.

Exclusion Criteria

  • •Any surgery performed in the previous days,
  • •Previous temporomandibular joint arthrotomies,
  • •Fewer than 20 teeth total or fewer than 10 teeth in each arch,
  • •Unstable residence or travel restrictions,
  • •Periodontal disease judged to be severe by the surgeon,
  • •Pregnancy,
  • •Previous mandibular surgery, and
  • •Inability to follow instructions or the study protocol.

Outcomes

Primary Outcomes

Patient Reported Outcome - Oral Health Related Quality of Life

Time Frame: one month

Secondary Outcomes

  • Pain(one month)

Study Sites (1)

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