Oral Teleconsultation (EDENT1)

July 29, 2019 updated by: University Hospital, Montpellier

Validation Study of Oral Teleconsultation

In this study we want to compare a dental diagnose during face to face consultation vs remote consultation with telemedicine device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Using Soprocare® camera, videos of patients' oral cavity are recorded and analysed remotely. 200 patients have been included: 100 in Montpellier (France) and 100 in Kitakyushu (Japan).

A classical face-to-face oral consultation is realized using ICDAS II classification. Then a student recorded 6 videos of patients' mouth: one video by sector, showing each face of molars and premolars in cario fluorescence mode of Soprocare® and one video of the maxillary and mandibular incisor-canine block in perio mode.

In a third step, a remote dentist analysed videos and made a telediagnosis using the same classification. Dental hygiene and missing teeth are also noted in classical and tele diagnostic.

The direct and the tele diagnostic are compared.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject is aged at least 18 years
  • The subject must be given free and informed consent
  • Topics scheduled consultation from the dental center of Montpellier University Hospital and the Center Kyushu University (Japan).

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Teleconsultation
Teleconsultation using a specific camera SoproCare®6
Other: teleconsultation
Determine the interest of teleconsultation in dentistry tool for the diagnosis of caries. Ie whether oral teleconsultations are of the same quality as conventional consultations for the diagnosis of caries ..

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnostic of caries
Time Frame: 1 day
Teleconsultation will be made using a specific camera SoproCare®6, the company Acteon ..
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

June 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 9173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe