Association Between Type of Ligating Brackets and Oral Health-related Quality of Life in Orthodontic Patients (OHIPS14ORTHO)

August 8, 2022 updated by: Fundación Universitaria CIEO
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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients wearing orthodontic treatment with mini tube system in upper and lower jaw or MBT conventional ligating pre-set appliances

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mini tube system
Mini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment.
Device: Mini tube system
Mini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral health-related quality of life (OHRQoL)
Time Frame: 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.
Change from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Universitaria CIEO

Investigators

  • Principal Investigator: Patricia Plaza, MSD, Fundación Universitaria CIEO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Anticipated)

November 19, 2022

Study Completion (Anticipated)

February 18, 2023

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UniCIEO OHIP-S14 ORTHO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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