Complete EdentulismNCT03283514
Esthetic Expectations of Edentulous Patients Followed in a French Dental Clinic
An observational study of Complete Edentulism, run by Hôpital Rothschild.
Trial summary
Esthetic is a major factor in complete denture (CD) success. Patient involvement in esthetic project plays a crucial role in denture acceptance and patient satisfaction. Historically, teeth choice and arrangement were made according to Frush and Ficher's recommendations focusing on natural looking of esthetics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- Complete denture
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Sep 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Totally edentulous subjects (20 women, 22 men, mena aged: 67.9 ± 12.2 years) attending maxillary CD in the department of prosthodontics of the Hopital Rothschild (AP-HP) are concerned by recruitment and are proposed to participate.
Inclusion criteria : Currently edentulous maxillary arch, literate French speakers, willing and able to complete the survey in a single sitting. Inclusion Criteria:
Exclusion Criteria: Aged under 18 years.
About this study
Esthetic is a major factor in complete denture (CD) success. Patient involvement in esthetic project plays a crucial role in denture acceptance and patient satisfaction. Historically, teeth choice and arrangement were made according to Frush and Ficher's recommendations focusing on natural looking of esthetics. Dentists may also propose to restore the dentate state looking for denture when preextraction data are available. Recently, a patient-centered approach based on attractivity has been proposed and may lead to in an appearance transcending the laws of nature.
The aim of the present study was to investigate actual denture esthetic expectations in a French edentate population followed in a university dental clinic (Rothschild Hospital , AP-HP).
Read the detailed description
Inclusion criteria : being currently edentulous within at least within the maxillary arch, literate French speakers, willing and able to complete the survey in a single sitting. Clinical data collection was made by a unique examiner and concerned length of edentulism, antagonist arch, existence of preextraction data, smile attractivity opinion. The respondents completed a questionnaire identifying their age, sex, educational and income level. Patients were also asked for their denture look preference among 4 esthetic projects: 1) restoring pre-extraction (dentate) looking, 2) restoring actual denture looking, 3) creating natural looking, 4) creating perfect looking, 5) no opinion. Each project was explained similarly by the same examiner. Statistical analysis using a Pearson Chi-squared test at a 0.05 level of significance was conducted for associations between esthetic projects preference and tested variables.
- Conditions
- Complete Edentulism
- Being tested
- Complete denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete dentureOther
questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
esthetic preferred project
Patients were asked for their denture-looking expectations among 4 esthetic projects: 1) restoring pre-extraction dentate looking, 2) restoring actual denture looking, 3) creating natural looking, 4) creating perfect looking, 5) no opinion.
Measured: Esthetic expectation evaluated at date of inclusion
Secondary outcomes (7)
age
Respondents completed a questionnaire identifying their age (in years)
Measured: evaluated at date of inclusion
gender
Respondents completed a questionnaire identifying their gender (man or woman)
Measured: evaluated at date of inclusion
educational level
Respondents completed a questionnaire identifying their educational level : last degree (no degree at al, French General Certificate Secondary Education, High School Diploma, Vocational Training Certificate taken at Secondary School, university degree)
Measured: evaluated at date of inclusion
month income level,
Respondents completed a questionnaire identifying their income level each month : in euros
Measured: evaluated at date of inclusion
length of edentulism,
Respondents completed a questionnaire identifying the duration of edentulism (in years)
Measured: evaluated at date of inclusion
smile attractivity opinion
Respondents completed a questionnaire identifying their smile attractivity opinion Respondents completed a questionnaire identifying the most attractive smile among 4 esthetic situations : preextraction-looking smile, denture-like smile, natural-like smile, perfect smile.
Measured: evaluated at date of inclusion
preextraction data available
Respondents completed a questionnaire identifying the existence of preextraction data available (available or not available)
Measured: evaluated at date of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start1 Sep 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies 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
- 42 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
- NCT03283514
- Sponsor's protocol ID
- 01
- Status last verified
- Sep 2017
- First submitted
- 9 Sep 2017
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Expectations of Edentulous Patients Followed in a French Dental Clinic
- ClinicalTrials.gov ID
- NCT03283514
- Acronym / sponsor ID
- 01
- Conditions
- Complete Edentulism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hôpital RothschildUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 14 Sep 2017 (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.
Esthetic is a major factor in complete denture (CD) success. Patient involvement in esthetic project plays a crucial role in denture acceptance and patient satisfaction. Historically, teeth choice and arrangement were made according to Frush and Ficher's recommendations focusing on natural looking of esthetics. Dentists may also propose to restore the dentate state looking for denture when preextraction data are available. Recently, a patient-centered approach based on attractivity has been proposed and may lead to in an appearance transcending the laws of nature.
The aim of the present study was to investigate actual denture esthetic expectations in a French edentate population followed in a university dental clinic (Rothschild Hospital , AP-HP).
Detailed description
Inclusion criteria : being currently edentulous within at least within the maxillary arch, literate French speakers, willing and able to complete the survey in a single sitting. Clinical data collection was made by a unique examiner and concerned length of edentulism, antagonist arch, existence of preextraction data, smile attractivity opinion. The respondents completed a questionnaire identifying their age, sex, educational and income level. Patients were also asked for their denture look preference among 4 esthetic projects: 1) restoring pre-extraction (dentate) looking, 2) restoring actual denture looking, 3) creating natural looking, 4) creating perfect looking, 5) no opinion. Each project was explained similarly by the same examiner. Statistical analysis using a Pearson Chi-squared test at a 0.05 level of significance was conducted for associations between esthetic projects preference and tested variables.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Totally edentulous subjects (20 women, 22 men, mena aged: 67.9 ± 12.2 years) attending maxillary CD in the department of prosthodontics of the Hopital Rothschild (AP-HP) are concerned by recruitment and are proposed to participate.
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 |
|---|---|---|
| Complete denturequestionnaire | Other | – |
Primary outcome
esthetic preferred project
Time frame: Esthetic expectation evaluated at date of inclusion
Patients were asked for their denture-looking expectations among 4 esthetic projects: 1) restoring pre-extraction dentate looking, 2) restoring actual denture looking, 3) creating natural looking, 4) creating perfect looking, 5) no opinion.
7 secondary outcomes
age
Time frame: evaluated at date of inclusion
gender
Time frame: evaluated at date of inclusion
educational level
Time frame: evaluated at date of inclusion
month income level,
Time frame: evaluated at date of inclusion
length of edentulism,
Time frame: evaluated at date of inclusion
smile attractivity opinion
Time frame: evaluated at date of inclusion
preextraction data available
Time frame: evaluated at date of inclusion
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 14 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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 Complete Edentulism, 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?
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 14 Sep 2017. 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?
esthetic preferred project (time frame: Esthetic expectation evaluated at date of inclusion). 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 14 Sep 2017.