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Completed

NCT Number: NCT04863170

Cross Cultural Adaptation and Validation 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.

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Key information

Conditions

Health-Related Quality of Life Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Dentofacial Deformities Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Valentina Duarte

Valparaíso, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthognathic Surgery

Procedure

surgical intervention of the maxilla and / or mandible that includes orthodontic treatment before and after surgery

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Hospital Carlos Van Buren

Other

Collaborators

  • Hospital San Borja-Arriaran
  • Hospital del Mar Research Institute (IMIM)
  • Pontificia Universidad Catolica de Valparaiso
  • Universidad de La Frontera
  • Universidad de Valparaiso
  • University of Chile

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2021
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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