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

Orthodontic Treatment Clinical Trial

— OHIPS14ORTHO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04773210
• Other study ID #: UniCIEO OHIP-S14 ORTHO
• Status: Recruiting
• Start date: April 12, 2021
• Est. completion date: February 18, 2023

Study information

• Verified date: August 2022
• Source: Fundación Universitaria CIEO
• Contact: Judith P Barrera, DDS
• Phone: 573002123863
• Email: jp.barrera[@]unicieo.edu.co
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 18, 2023
• Est. primary completion date: November 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Oral Health-related Quality of Life
• Orthodontic Treatment

Intervention

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

Locations

Country	Name	City	State
Colombia	Fundación Universitaria CIEO Uni-CIEO	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Universitaria CIEO

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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