Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-01 @ 2:21 AM
Study NCT ID:
NCT03499093
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2018-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French Version of the Orofacial Esthetic Scale
Sponsor:
Hôpital Rothschild
Organization:
Study Overview
Official Title:
Development and Validation of the French Version of the Orofacial Esthetic Scale: OES-F
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aims of this study were to develop a French version of the Orofacial Esthetic Scale (OES-F) and to investigate its psychometric properties.
The OES is an eight-item instrument that assesses self-reported orofacial esthetics in prosthodontic patients. The first seven items refer to direct esthetic impacts and the eight is a global assessment item. For each item, an 11-point numeric scale (ranged from 0 = very dissatisfied to 10 = very satisfied) is used, and the first seven scores are combined into a summary score from 0 (worst score) to 70 (best score). The original English version of the OES was translated into French according to the guidelines. The reliability (internal consistency and test-retest reliability) and validity (convergent and discriminative validities) were tested in a sample of 140 patients. To assess test-retest reliability, 35 patients answered twice the OES-F with a temporal distance of two weeks apart.
The OES is an eight-item instrument that assesses self-reported orofacial esthetics in prosthodontic patients. The first seven items refer to direct esthetic impacts and the eight is a global assessment item. For each item, an 11-point numeric scale (ranged from 0 = very dissatisfied to 10 = very satisfied) is used, and the first seven scores are combined into a summary score from 0 (worst score) to 70 (best score). The original English version of the OES was translated into French according to the guidelines. The reliability (internal consistency and test-retest reliability) and validity (convergent and discriminative validities) were tested in a sample of 140 patients. To assess test-retest reliability, 35 patients answered twice the OES-F with a temporal distance of two weeks apart.
Detailed Description:
Participants From September 2016 to december 2017, 160 patients aged over 18 have been recruited at the university dental clinic of the Rothschild Hospital, Paris, among patients pending dental treatment. Inclusion criteria were : literate French speakers, willing and able to complete the survey in a single setting. Patients suffering from head and neck tumors, defects after tumor resection, radiotherapy treatment, patients suffering from dementia or cognitive impairment, and communication difficulties were excluded.
The pilot version was tested in a sample of twenty patients who were not involved in the main study. One hundred forty patients answered the final French version of the questionnaire to assess the psychometric properties of the OES-F. They were first divided into two groups according to their prosthetic needs. Participants were further allocated to two groups according to their esthetical concerns. Finally, the french version of the OES was tested with n=35 prothetic patients with esthetic expectations (PP-E), with n=35 prothetic patients without esthetic expectations (PP-NE), with n=35 subjects with esthetic concerns (C-E) and n=35 subjects without any esthetic concern (C-NE). Prosthetic patients were recruited either during the initial visit or before prosthetic treatment. Control subjects were recruited either during their initial visit or a follow-up consultation.
All subjects provided written informed consent before inclusion and had their anonymity respected throughout the course of the study. The study was approved by the Ethics Committee of research projects of the Robert Debré Hospital (n° 2016/303(2). In application of the french law of January 6, 1978 relative to information technology, the study has been declared to the national data protection agency under the number 1977961v0.
Development of the french OES version The traduction and cross-cultural adaptation was performed according to the guidelines. Briefly, the english version was first translated into french by two dental practitioners and then back translated in english by two native english speakers. Both translated versions were discussed by the research team and appropriate changes were formulated to the french version if necessary to clarify any item of the questionnaire. Clear understanding of any question and the entire french version of the questionnaire was tested with twenty participants. Minor changes concerned only formulation of general presentation of the questionnaire.
The psychometric validity of the final french version was finally tested, including reliability and validity.
The pilot version was tested in a sample of twenty patients who were not involved in the main study. One hundred forty patients answered the final French version of the questionnaire to assess the psychometric properties of the OES-F. They were first divided into two groups according to their prosthetic needs. Participants were further allocated to two groups according to their esthetical concerns. Finally, the french version of the OES was tested with n=35 prothetic patients with esthetic expectations (PP-E), with n=35 prothetic patients without esthetic expectations (PP-NE), with n=35 subjects with esthetic concerns (C-E) and n=35 subjects without any esthetic concern (C-NE). Prosthetic patients were recruited either during the initial visit or before prosthetic treatment. Control subjects were recruited either during their initial visit or a follow-up consultation.
All subjects provided written informed consent before inclusion and had their anonymity respected throughout the course of the study. The study was approved by the Ethics Committee of research projects of the Robert Debré Hospital (n° 2016/303(2). In application of the french law of January 6, 1978 relative to information technology, the study has been declared to the national data protection agency under the number 1977961v0.
Development of the french OES version The traduction and cross-cultural adaptation was performed according to the guidelines. Briefly, the english version was first translated into french by two dental practitioners and then back translated in english by two native english speakers. Both translated versions were discussed by the research team and appropriate changes were formulated to the french version if necessary to clarify any item of the questionnaire. Clear understanding of any question and the entire french version of the questionnaire was tested with twenty participants. Minor changes concerned only formulation of general presentation of the questionnaire.
The psychometric validity of the final french version was finally tested, including reliability and validity.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: