Association Between Type of Ligating Brackets and Oral Health-related Quality of Life in Orthodontic Patients
NCT ID: NCT04773210
Last Updated: 2022-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2021-04-12
2023-02-18
Brief Summary
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Detailed Description
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The outcome variable is Oral health-related quality of life (OHRQoL) measured with OHIP-S14 Ortho instrument, which was validated in Spanish in patients with orthodontic treatment. Consists of 14 questions that address seven dimensions (functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap), specifically related to orthodontic treatment. The OHIP-S14 Ortho score is between 0 to 56. Where 0 indicates a positive impact and 56 an unfavorable impact. The questionnaire will be self-administered online during the first 6 months of treatment: T0: prior to cementation, T1: 24 -48 hours after cementation, T2: 1 month after cementation, T3: 3 months after cementation and T4: 6 months after cementation.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mini tube system
Mini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment.
Mini tube system
Mini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment
Conventional ligating brackets
Conventional ligating brackets (Gemini 3M Unitek Orthodontic Products bracket, Calif, USA) with Nitinol Classic or superelastic (SE) archwires 0.014 and 0.016 orthodontic treatment.
Conventional ligating brackets
Conventional ligating brackets (Gemini 3M Unitek Orthodontic Products bracket, Calif, USA) with Nitinol Classic or superelastic (SE) archwires 0.014 and 0.016 orthodontic treatment
Interventions
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Mini tube system
Mini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment
Conventional ligating brackets
Conventional ligating brackets (Gemini 3M Unitek Orthodontic Products bracket, Calif, USA) with Nitinol Classic or superelastic (SE) archwires 0.014 and 0.016 orthodontic treatment
Eligibility Criteria
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Inclusion Criteria
* Moderate treatment complexity determined by Dental Aesthetics Index DAI moderate.
* Orthodontic treatment with mini tube system in upper and lower jaw or MBT conventional ligating pre-set appliances
* Non- extractions at the start of orthodontic treatment
* Non- placement of mini-implants at the start of orthodontic treatment
Exclusion Criteria
* Dental caries at the start of orthodontic treatment
* Periodontal disease at the start of orthodontic treatment
* Systemic disease
* Orthognathic surgery indicated
* Cognitive disorders
* Non understand the Spanish language
18 Years
35 Years
ALL
No
Sponsors
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Fundación Universitaria CIEO
OTHER
Responsible Party
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Principal Investigators
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Patricia Plaza, MSD
Role: PRINCIPAL_INVESTIGATOR
Fundación Universitaria CIEO
Locations
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Fundación Universitaria CIEO Uni-CIEO
Bogotá, , Colombia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UniCIEO OHIP-S14 ORTHO
Identifier Type: -
Identifier Source: org_study_id
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