Cross Cultural Adaptation and Validation of Orthognathic Quality of Life Questionnaire (OQLQ)

April 23, 2021 updated by: Hospital Carlos Van Buren

Cross Cultural Adaptation and Validation of Chilean Version of Orthognathic Quality of Life Questionnaire (OQLQ)

The aim of this study was to develop a Spanish version of the Orthognathic Quality of Life Questionnaire (OQLQ) that is conceptually equivalent to the original questionnaire, as well as acceptable, reliable, valid, and responsive for use in Chilean patients with dentofacial deformities.The cross cultural adaptation process was carried out according to the recommended standard methodology with direct and back-translation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A prospective longitudinal multicenter study of adult patients diagnosed with dentofacial deformity was carried out, self-administrating OQLQ, OHIP-14 (Oral Health Impact Profile), and SF-36 (Short Form 36 Health Survey) during the presurgery visit in order to examine construct validity. To evaluate reproducibility, questionnaires were re-administered 4 weeks later to subjects with a stable dental condition. Responsiveness was assessed among subjects followed up until 3 months after surgery and finally changes in health-related quality of life was assessed comparing baseline pre-surgery to 3 and 6 months post-surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Contacts and Locations

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

Study Locations

  • Chile
      • Valparaíso, Chile
        • Valentina Duarte

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients over 18 years old with dentofacial deformity Class II or III in orthodontic-surgical treatment

Description

Inclusion Criteria:

  • Adults patients over 18 years old with dentofacial deformity.

Exclusion Criteria:

  • Patients with congenital abnormalities such as craniofacial syndrome or cleft lip/palate and sequels due to maxillofacial trauma were excluded

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Metric properties of Orthognathic Quality of Life Questionnaire (OQLQ): Reliability
Time Frame: 4 weeks follow-up

To measure this metric property, internal consistency and test-retest reproducibility were assessed. The orthognathic quality of life questionnaire (OQLQ) was applied twice, with four weeks between tests.

To assess reliability, the internal consistency was estimated by the Cronbach alpha coefficient, and the test-retest reproducibility was estimated by the intraclass correlation coefficient.

The orthognathic quality of life questionnaire is a condition specific instrument for assessment oral health quality of life in dentofacial deformities patients 22 ítems values: min = 0 / max = 88 higher scores mean a worse outcome
4 weeks follow-up
Metric properties of Orthognathic Quality of Life Questionnaire (OQLQ): Validity
Time Frame: baseline

Validity refers to the degree to which the instrument measures what it purports to measure.

Construct validity was evaluated analyzing the hypothesized relationships between scores by calculating the Spearman correlation coefficients.

The orthognathic quality of life questionnaire is a condition specific instrument for assessment oral health quality of life in dentofacial deformities patients 22 ítems values: min = 0 / max = 88 higher scores mean a worse outcome
baseline
Metric properties of Orthognathic Quality of Life Questionnaire (OQLQ): Responsiveness to change
Time Frame: baseline - 3 months follow-up

Responsiveness refers to an instrument's ability to detect change. To evaluate responsiveness of the orthognathic quality of life questionnaire (OQLQ) we applied twice: first one week before surgery (T1), and then three months after surgery (T2) To evaluate responsiveness, a paired t-test was used to assess the score changes in patients undergoing orthognathic surgery. The magnitude of the change was evaluated calculating the standardized response mean.

The orthognathic quality of life questionnaire is a condition specific instrument for assessment oral health quality of life in dentofacial deformities patients 22 ítems values: min = 0 / max = 88 higher scores mean a worse outcome
baseline - 3 months follow-up
changes in oral health related quality of life after orthognathic surgery assessed with Orthognathic Quality of Life Questionnaire (OQLQ)
Time Frame: baseline to 3 and 6 months follow-up

Orthognathic quality of life questionnaire (OQLQ) was applied at 3 times: baseline, one week before surgery (T1), three months after surgery (T2) and 6 months after surgery (T3).

A paired t-test was used to assess the mean (SD) changes in patients undergoing orthognathic surgery. The magnitude of the change was evaluated calculating the standardized response mean (SRM).

The orthognathic quality of life questionnaire is a condition specific instrument for assessment oral health quality of life in dentofacial deformities patients 22 ítems values: min = 0 / max = 88 higher scores mean a worse outcome
baseline to 3 and 6 months follow-up
changes in oral health related quality of life after orthognathic surgery assessed with Short form Oral Health Impact Profile (OHIP-14)
Time Frame: baseline to 3 and 6 months follow-up

Short form Oral Health Impact Profile (OHIP-14) was applied at 3 times: baseline, one week before surgery (T1), three months after surgery (T2) and 6 months after surgery (T3).

A paired t-test was used to assess the mean (SD) changes in patients undergoing orthognathic surgery. The magnitude of the change was evaluated calculating the standardized response mean (SRM).

The Short Form Oral Health Impact Profile (OHIP-14) is an instrument for assessment oral health-related quality of life.

14 ítems values: min = 0 / max = 56 higher scores mean a worse outcome
baseline to 3 and 6 months follow-up
changes in health related quality of life after orthognathic surgery assessed with Short Form Health Survey (SF-36)
Time Frame: baseline to 3 and 6 months follow-up

The Short Form Health Survey (SF-36) was applied at 3 times: baseline, one week before surgery (T1), three months after surgery (T2) and 6 months after surgery (T3).

A paired t-test was used to assess the mean (SD) changes in patients undergoing orthognathic surgery. The magnitude of the change was evaluated calculating the standardized response mean (SRM).

The Short Form Health Survey (SF-36) is a generic health-related quality of life questionnaire 36 ítems in addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.

higher scores mean a better outcome
baseline to 3 and 6 months follow-up

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Carlos Van Buren

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad de Valparaiso
University of Chile
Universidad de La Frontera
Hospital del Mar Research Institute (IMIM)
Pontificia Universidad Catolica de Valparaiso
Hospital San Borja-Arriaran

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Valentina Duarte, Hospital Carlos Van Buren

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 3, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 3, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ORD 2436 / 30-11-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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