NCT03283514

Brief 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. 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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

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 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

September 9, 2017

Last Update Submit

September 12, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Esthetic expectation evaluated at date of inclusion

Secondary Outcomes (7)

  • age

    evaluated at date of inclusion

  • gender

    evaluated at date of inclusion

  • educational level

    evaluated at date of inclusion

  • month income level,

    evaluated at date of inclusion

  • length of edentulism,

    evaluated at date of inclusion

  • +2 more secondary outcomes

Interventions

questionnaire

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Denture, Complete

Intervention Hierarchy (Ancestors)

DenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
maitre de conférences -praticien hospitalier

Study Record Dates

First Submitted

September 9, 2017

First Posted

September 14, 2017

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 14, 2017

Record last verified: 2017-09