Association Between Type of Ligating Brackets and Oral Health-related Quality of Life in Orthodontic Patients
OHIPS14ORTHO
1 other identifier
observational
200
1 country
1
Brief Summary
To evaluate the association of the level of quality of life related to oral health, between treatment with the minitube system and conventional ligation brackets, in adult patients with moderate malocclusion, during the first six months, of orthodontic treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2021
CompletedFirst Posted
Study publicly available on registry
February 26, 2021
CompletedStudy Start
First participant enrolled
April 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2023
CompletedAugust 11, 2022
August 1, 2022
1.6 years
February 23, 2021
August 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oral health-related quality of life (OHRQoL)
Oral health-related quality of life (OHRQoL) measured with OHIP-S14 Ortho instrument, which was validated in Spanish in patients with orthodontic treatment.
Change from baseline to 6 months
Study Arms (2)
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.
Interventions
Mini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment
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
Patients wearing orthodontic treatment with mini tube system in upper and lower jaw or MBT conventional ligating pre-set appliances
You may qualify if:
- Age range from 18 to 35
- 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
You may not qualify if:
- Craniofacial anomalies
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fundación Universitaria CIEO Uni-CIEO
Bogotá, 1, Colombia
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Plaza, MSD
Fundación Universitaria CIEO
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2021
First Posted
February 26, 2021
Study Start
April 12, 2021
Primary Completion
November 19, 2022
Study Completion
February 18, 2023
Last Updated
August 11, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share