Oral Health-related Quality of LifeOHIPS14ORTHONCT04773210
Association Between Type of Ligating Brackets and Oral Health-related Quality of Life in Orthodontic Patients
An observational study of Oral Health-related Quality of Life and Orthodontic Treatment, run by Fundación Universitaria CIEO at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Oral Health-related Quality of Life, Orthodontic Treatment
- What is being tested?
- Mini tube system and Conventional ligating brackets
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteColombia
- Study dates
- 12 Apr 2021to 18 Feb 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients wearing orthodontic treatment with mini tube system in upper and lower jaw or MBT conventional ligating pre-set appliances
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Fundación Universitaria CIEO Uni-CIEO
Bogotá, 1
Judith Barrera, DDS, 7437919, jp.barrera@unicieo.edu.co
Patricia Plaza, MSD, 6371170, investigacion.ortodoncia@unicieo.edu.co
About this study
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.
Read the 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.
- Being tested
- Mini tube system, Conventional ligating brackets
- Keywords
- Health-Related Quality of Life, Oral Health Impact Profile, Orthodontics, Corrective, Orthodontic Appliances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini tube systemDevice
Mini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment
Conventional ligating bracketsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Mini tube system | Mini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment. Receives: Device: Mini tube system | |
| 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. Receives: Device: Conventional ligating brackets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start12 Apr 2021
- Primary completion19 Nov 2022 (estimated)
- Study completion18 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health-related Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria CIEO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Plaza, MSD, Principal investigator, Fundación Universitaria CIEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773210
- Sponsor's protocol ID
- UniCIEO OHIP-S14 ORTHO
- Acronym
- OHIPS14ORTHO
- Status last verified
- Aug 2022
- First submitted
- 23 Feb 2021
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Type of Ligating Brackets and Oral Health-related Quality of Life in Orthodontic Patients
- ClinicalTrials.gov ID
- NCT04773210
- Acronym / sponsor ID
- OHIPS14ORTHO / UniCIEO OHIP-S14 ORTHO
- Keywords
- Health-Related Quality of Life, Oral Health Impact Profile, Orthodontics, Corrective, Orthodontic Appliances
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundación Universitaria CIEOUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 19 Nov 2022 (estimated)
- Study completion
- 18 Feb 2023 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini tube system | – | Device: Mini tube systemMini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment. |
| Conventional ligating brackets | – | Device: Conventional ligating bracketsConventional ligating brackets (Gemini 3M Unitek Orthodontic Products bracket, Calif, USA) with Nitinol Classic or superelastic (SE) archwires 0.014 and 0.016 orthodontic treatment. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients wearing orthodontic treatment with mini tube system in upper and lower jaw or MBT conventional ligating pre-set appliances
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Craniofacial anomalies
- Dental caries at the start of orthodontic treatment
- Periodontal disease at the start of orthodontic treatment
- Systemic disease
- Orthognathic surgery indicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini tube systemMini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment | Device | Mini tube system |
| Conventional ligating bracketsConventional 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 |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Plaza, MSD principal investigator
Fundación Universitaria CIEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Health-related Quality of Life and Orthodontic Treatment, run by Fundación Universitaria CIEO at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judith P Barrera, DDS (573002123863, jp.barrera@unicieo.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral health-related quality of life (OHRQoL) (time frame: Change from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.