Clinical trial NCT04863170: Cross Cultural Adaptation and Validation of Orthognathic Quality of Life Questionnaire (OQLQ)
Official title: Cross Cultural Adaptation and Validation of Chilean Version of Orthognathic Quality of Life Questionnaire (OQLQ)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health-related Quality of Life
Dentofacial Deformities
Keywords: Health-related quality of life
Orthognathic surgery
Dentofacial deformities
Lead sponsor: Hospital Carlos Van Buren
Sponsor class: OTHER
Collaborators: name: Universidad de La Frontera
name: University of Chile
name: Pontificia Universidad Catolica de Valparaiso
name: Hospital San Borja-Arriaran
name: Universidad de Valparaiso
name: Hospital del Mar Research Institute (IMIM)
First posted: 2021-04-28
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients over 18 years old with dentofacial deformity Class II or III in orthodontic-surgical treatment

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metric properties of Orthognathic Quality of Life Questionnaire (OQLQ): Reliability
timeFrame: 4 weeks follow-up
measure: Metric properties of Orthognathic Quality of Life Questionnaire (OQLQ): Validity
timeFrame: baseline
measure: Metric properties of Orthognathic Quality of Life Questionnaire (OQLQ): Responsiveness to change
timeFrame: baseline - 3 months follow-up
measure: changes in oral health related quality of life after orthognathic surgery assessed with Orthognathic Quality of Life Questionnaire (OQLQ)
timeFrame: baseline to 3 and 6 months follow-up
measure: changes in oral health related quality of life after orthognathic surgery assessed with Short form Oral Health Impact Profile (OHIP-14)
timeFrame: baseline to 3 and 6 months follow-up
measure: changes in health related quality of life after orthognathic surgery assessed with Short Form Health Survey (SF-36)
timeFrame: baseline to 3 and 6 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Valparaíso
country: Chile
facility: Valentina Duarte
Study officials:
affiliation: Hospital Carlos Van Buren
name: Valentina Duarte
role: PRINCIPAL_INVESTIGATOR
References: