NCT03499093

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

1.3 years

First QC Date

March 28, 2018

Last Update Submit

April 8, 2018

Conditions

Keywords

estheticsorofacial esthetic scale

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change from baseline overall impression (eight item of OES questionnaire) at two weeks

    evaluated at date of inclusion and two weeks later

Study Arms (4)

Prosthetic patient with esthetic expectations

Prosthetic patients with esthetic expectations (PP-E, n=35), Patients seeking for restoration or replacement of anterior teeth, or expressing any esthetic expectation

Other: OES

Prosthetic patients without esthetic expectations

Prosthetic patients without esthetic expectations (PP-NE, n=35) Patients pending restoration or replacement of posterior teeth (premolars and molars), expressing only functional expectation

Other: OES

Dental patient with esthetic concern

Dental patient with esthetic concern(C-E, n=35) Patient consulting for follow up, having crowns or removable denture replacing anterior teeth

Other: OES

Dental patient without any esthetic concern

Dental patient without any esthetic concern (C-NE, n=35) Patient consulting for follow up, having no crown or removable denture replacing anterior teeth.

Other: OES

Interventions

OESOTHER

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.

Also known as: Photographs
Dental patient with esthetic concernDental patient without any esthetic concernProsthetic patient with esthetic expectationsProsthetic patients without esthetic expectations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients pending dental treatment or follow up at the university dental clinic of the Rothschild Hospital, Paris.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Moire Topography

Intervention Hierarchy (Ancestors)

PhotogrammetryPhotographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInterferometryInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in odontology-hospital practitioner

Study Record Dates

First Submitted

March 28, 2018

First Posted

April 17, 2018

Study Start

September 26, 2016

Primary Completion

January 10, 2018

Study Completion

January 10, 2018

Last Updated

April 17, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share