Dental CareEDENT2NCT02904018
Validation Study of Oral Teleconsultation
An observational study of Dental Care, run by University Hospital, Montpellier.
Trial summary
In this study we want to evaluate the oral care pathway after an oral teleconsultation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dental Care
- What is being tested?
- teleconsultation
- Type of treatment
- Pill or oral medicine
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Sep 2016
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People who are in long-term care home with oral telemedicine activity
Who may be able to join
- The subject is aged at least 18 years
- Patients cared for in their host institution
Who cannot join
- NA
About this study
Official title: Validation Study of Oral Teleconsultation - Study EDENT2
In this study we want to evaluate the oral care pathway after an oral teleconsultation.
Read the detailed description
An oral teleconsultation was proposed to the 461 residents of the public hospital of Uzès. A specifically trained nurse recorded 4 videos (1 per quadrant) per mouth with an intra-oral camera using fluorescent light (Soprocare®) and keyed in information about the resident (general state, identification,…). These data were recorded and sent onto a central secured server, through a specific piece of software (e-DENT®). The dentists from the University Hospital of Montpellier were then able to analyse the videos remotely, make a diagnosis and organise each resident's oral care.
- Conditions
- Dental Care
- Being tested
- teleconsultation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teleconsultationOther
Patients performing oral care required as a result of their diagnosis by teleconsultation in vulnerable populations (elderly, disabled adults).
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic of caries
Teleconsultation will be made using a specific camera SoproCare®6, the company Acteon
Measured: 1 day
Secondary outcomes (1)
Diagnostic of caries
Teleconsultation will be made using a specific camera SoproCare®6, the company Acteon
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startMar 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CareStudies 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
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904018
- Sponsor's protocol ID
- 9370
- Acronym
- EDENT2
- Status last verified
- Feb 2014
- First submitted
- 7 Sep 2016
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of Oral Teleconsultation - Study EDENT2
- ClinicalTrials.gov ID
- NCT02904018
- Acronym / sponsor ID
- EDENT2 / 9370
- Conditions
- Dental Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Sep 2016 (estimated)
- 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.
In this study we want to evaluate the oral care pathway after an oral teleconsultation.
Detailed description
An oral teleconsultation was proposed to the 461 residents of the public hospital of Uzès. A specifically trained nurse recorded 4 videos (1 per quadrant) per mouth with an intra-oral camera using fluorescent light (Soprocare®) and keyed in information about the resident (general state, identification,…). These data were recorded and sent onto a central secured server, through a specific piece of software (e-DENT®). The dentists from the University Hospital of Montpellier were then able to analyse the videos remotely, make a diagnosis and organise each resident's oral care.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who are in long-term care home with oral telemedicine activity
Key inclusion criteria (2 listed)
- The subject is aged at least 18 years
- Patients cared for in their host institution
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| teleconsultationPatients performing oral care required as a result of their diagnosis by teleconsultation in vulnerable populations (elderly, disabled adults). | Other | – |
Primary outcome
Diagnostic of caries
Time frame: 1 day
Teleconsultation will be made using a specific camera SoproCare®6, the company Acteon
1 secondary outcome
Diagnostic of caries
Time frame: 6 months
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 16 Sep 2016.
- 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 Dental Care, run by University Hospital, Montpellier.
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 2 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 16 Sep 2016. 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?
Diagnostic of caries (time frame: 1 day). 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 16 Sep 2016.