NCT04773210

Association Between Type of Ligating Brackets and Oral Health-related Quality of Life in Orthodontic Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Fundación Universitaria CIEO · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Oral Health-related Quality of Life
• Orthodontic Treatment

Interventions

Type	Name	Description
DEVICE	Mini tube system	Mini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment
DEVICE	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

Timeline

• Start date: 2021-04-12
• Primary completion: 2022-11-19
• Completion: 2023-02-18
• First posted: 2021-02-26
• Last updated: 2022-08-11

Locations

1 site across 1 country: Colombia