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Clinical Trial 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.


Clinical Trial Description

This is an observational cohort study with 1: 1 allocation ratio. The sample will be of 200 participants, divided into two groups. People over 18 years of age will be included; with moderate treatment complexity determined by Dental Aesthetics Index DAI. The study interventions are: (1) Mini tube system (FLOW-JAC System, Bogotá, Colombia) and (2) Conventional ligating brackets (Gemini 3M Unitek Orthodontic Products bracket, Calif, USA) with Nitinol Classic or superelastic (SE) archwires 0.014 and 0.016. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04773210
Study type Observational [Patient Registry]
Source Fundación Universitaria CIEO
Contact Judith P Barrera, DDS
Phone 573002123863
Email jp.barrera@unicieo.edu.co
Status Recruiting
Phase
Start date April 12, 2021
Completion date February 18, 2023

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