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

Study Overview
=================
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.

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

Conditions
-----------------
Oral Health-related Quality of Life, Orthodontic Treatment

Intervention / Treatment
-----------------
* Device: Mini tube system
* Device: Conventional ligating brackets


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mini tube system<br>Mini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment. | Device: Mini tube system<br>* Mini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment<br>|
| Conventional ligating brackets<br>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<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health-Related Quality of Life, Oral Health Impact Profile, Orthodontics, Corrective, Orthodontic Appliances