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

NCT04863170 | Completed

• 1 other identifier: ORD 2436 / 30-11-18
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Health-related Quality of Life; Dentofacial Deformities

Keywords

Health-related quality of life; Orthognathic surgery; Dentofacial deformities

Outcome Measures

Primary Outcomes (6)

• Metric properties of Orthognathic Quality of Life Questionnaire (OQLQ): Reliability

  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

  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

  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)

  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)

  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)

  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

Interventions

orthognathic surgery PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adults patients over 18 years old with dentofacial deformity.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Carlos Van Buren: lead
• Universidad de La Frontera: collaborator
• University of Chile: collaborator
• Pontificia Universidad Catolica de Valparaiso: collaborator
• Hospital San Borja-Arriaran: collaborator
• Universidad de Valparaiso: collaborator
• Hospital del Mar Research Institute (IMIM): collaborator

Study Sites (1)

Valentina Duarte

Valparaíso, Chile

Location

MeSH Terms

Conditions

Dentofacial Deformities

Interventions

Orthognathic Surgery

Condition Hierarchy (Ancestors)

Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Study Officials

• Valentina Duarte

  Hospital Carlos Van Buren

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 28, 2021
• Study Start: November 21, 2018
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)