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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04773210
Acronym
OHIPS14ORTHO
Enrollment
200
Registered
2021-02-26
Start date
2021-04-12
Completion date
2023-02-18
Last updated
2022-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Health-related Quality of Life, Orthodontic Treatment

Keywords

Health-Related Quality of Life, Oral Health Impact Profile, Orthodontics, Corrective, Orthodontic Appliances

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.

Interventions

DEVICEMini tube system

Mini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment

DEVICEConventional 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

Sponsors

Fundación Universitaria CIEO
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

Colombia

Contacts

Primary ContactJudith P Barrera, DDS
jp.barrera@unicieo.edu.co573002123863
Backup ContactPatricia Plaza, MSD
investigacion.ortodoncia@unicieo.edu.co573183973032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026