French Version of the Orofacial Esthetic Scale

Esthetics, Dental Clinical Trial

Official title:

Development and Validation of the French Version of the Orofacial Esthetic Scale: OES-F

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499093
• Other study ID #: 2016/303 (2)
• Status: Completed
• First received: March 28, 2018
• Last updated: April 8, 2018
• Start date: September 26, 2016
• Est. completion date: January 10, 2018

Study information

• Verified date: April 2018
• Source: Hôpital Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• literate French speakers, willing and able to complete the survey

Exclusion Criteria:

• Patients suffering from head and neck tumors, defects after tumor resection, radiotherapy treatment, patients suffering from dementia or cognitive impairment, and communication difficulties

Related Conditions & MeSH terms

• Esthetics, Dental

Intervention

Other:
• OES
The first seven items of OES refer to face, facial profile, mouth, teeth alignment, teeth form, teeth color and gums. They are combined into an OES summary score ranging from 0 to 70. The eight item of OES is an overall impression item and is not included in the summary score. Internal Consistency was determined using Cronbach's alpha and inter-item correlation for the OES scores (n=140). Test-Retest Reliability was assessed using Intraclass Correlation Coefficient. Patients with prosthetic needs (n=20 PP-E subjects and n=15 PP-NE subjects) completed twice the OES-F at an interval of two weeks. Convergent validity was assessed by comparing mean OES summary scores evaluated by participant of the esthetic group (PP-E, n=35) and by an expert group. Expert OES score were based on three photographs of each participant. Discriminative validity was tested by comparing the OES summary scores using a one-way ANOVA and Scheffe post hoc test.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Rothschild

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline orofacial esthetic scale (OES) summary score at two weeks	The first seven items refer to esthetic components: face, facial profile, mouth (smile, lips, and visible teeth), teeth alignment, teeth form, teeth color and gums. These seven scores are combined into an OES summary score ranging from 0 (worst score, patient is very dissatisfied with all esthetics items) to 70 (best score, patient is very satisfied with all esthetics items).	evaluated at date of inclusion and two weeks later
Secondary	Change from baseline overall impression (eight item of OES questionnaire) at two weeks	The eight item is an overall impression item and is not included in the summary score.	evaluated at date of inclusion and two weeks later