An observational study in Oral Health-related Quality of Life and Orthodontic Treatment, sponsored by Fundación Universitaria CIEO. Status unknown at 1 site in Colombia. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2022-08-11.
Sponsored by Fundación Universitaria CIEO · Observational
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.
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.
Fundación Universitaria CIEO is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients wearing orthodontic treatment with mini tube system in upper and lower jaw or MBT conventional ligating pre-set appliances
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Exclusion Criteria:
Mini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment.
Device: Mini tube system
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.
Device: Conventional ligating brackets
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
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.
Time frame: Change from baseline to 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2021 (actual). Primary completion is estimated for Nov 2022, 19 months after the start.
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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Fundación Universitaria CIEO