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

• Conditions: Orthodontic Treatment; Oral Health-related Quality of Life
• Interventions: Device: Conventional ligating brackets; Device: Mini tube system

• Registration Number: NCT04773210
• Lead Sponsor: Fundación Universitaria CIEO

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.

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.

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-26
• Study Start: 2021-04-12
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-11
• Primary Completion: 2022-11-19
• Study Completion: 2023-02-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conventional ligating brackets	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.
Mini tube system	Mini tube system	Mini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment.

Primary Outcome Measures

Name	Time	Method
Oral health-related quality of life (OHRQoL)	Change from baseline to 6 months	Oral health-related quality of life (OHRQoL) measured with OHIP-S14 Ortho instrument, which was validated in Spanish in patients with orthodontic treatment.

Trial Locations

Locations (1)

Fundación Universitaria CIEO Uni-CIEO; 🇨🇴 Bogotá, Colombia