Esthetics, DentalNCT03499093
French Version of the Orofacial Esthetic Scale
An observational study of Esthetics, Dental, run by Hôpital Rothschild.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esthetics, Dental
- What is being tested?
- OES
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2016to 10 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients pending dental treatment or follow up at the university dental clinic of the Rothschild Hospital, Paris.
Who may be able to join
- literate French speakers, willing and able to complete the survey
Who cannot join
- Patients suffering from head and neck tumors, defects after tumor resection, radiotherapy treatment, patients suffering from dementia or cognitive impairment, and communication difficulties
About this study
Official title: Development and Validation of the French Version of the Orofacial Esthetic Scale: OES-F
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.
Read the 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.
- Conditions
- Esthetics, Dental
- Being tested
- OES
- Keywords
- esthetics, orofacial esthetic scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OESOther
Also called Photographs
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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. Receives: Other: OES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
The eight item is an overall impression item and is not included in the summary score.
Measured: evaluated at date of inclusion and two weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start26 Sep 2016
- Primary completion10 Jan 2018
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esthetics, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Rothschild
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Braud Adeline, Hôpital Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499093
- Sponsor's protocol ID
- 2016/303 (2)
- Status last verified
- Apr 2018
- First submitted
- 28 Mar 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the French Version of the Orofacial Esthetic Scale: OES-F
- ClinicalTrials.gov ID
- NCT03499093
- Acronym / sponsor ID
- 2016/303 (2)
- Conditions
- Esthetics, Dental
- Keywords
- esthetics, orofacial esthetic scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hôpital RothschildUniversity, hospital or other
- Study start
- 26 Sep 2016 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prosthetic patient with esthetic expectations | – | Other: OESProsthetic patients with esthetic expectations (PP-E, n=35), Patients seeking for restoration or replacement of anterior teeth, or expressing any esthetic expectation |
| Prosthetic patients without esthetic expectations | – | Other: OESProsthetic patients without esthetic expectations (PP-NE, n=35) Patients pending restoration or replacement of posterior teeth (premolars and molars), expressing only functional expectation |
| Dental patient with esthetic concern | – | Other: OESDental patient with esthetic concern(C-E, n=35) Patient consulting for follow up, having crowns or removable denture replacing anterior teeth |
| Dental patient without any esthetic concern | – | Other: OESDental patient without any esthetic concern (C-NE, n=35) Patient consulting for follow up, having no crown or removable denture replacing anterior teeth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients pending dental treatment or follow up at the university dental clinic of the Rothschild Hospital, Paris.
Key inclusion criteria (1 listed)
- literate French speakers, willing and able to complete the survey
Key exclusion criteria (1 listed)
- Patients suffering from head and neck tumors, defects after tumor resection, radiotherapy treatment, patients suffering from dementia or cognitive impairment, and communication difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OESAlso: PhotographsThe 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. | Other | Dental patient with esthetic concern, Dental patient without any esthetic concern, Prosthetic patient with esthetic expectations, Prosthetic patients without esthetic expectations |
Primary outcome
Change from baseline orofacial esthetic scale (OES) summary score at two weeks
Time frame: evaluated at date of inclusion and two weeks later
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).
1 secondary outcome
Change from baseline overall impression (eight item of OES questionnaire) at two weeks
Time frame: evaluated at date of inclusion and two weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Esthetics, Dental, run by Hôpital Rothschild.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline orofacial esthetic scale (OES) summary score at two weeks (time frame: evaluated at date of inclusion and two weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.