Tooth Diseasese-DENT-EHPADNCT03871569
Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home
A study testing bucco-dental teleexpertise in people with Tooth Diseases, run by University Hospital, Montpellier at 13 sites in France.
Trial summary
Oral care in medical and social institutions is a real public health problem. The impact of poor oral health on the general state of residents but also on their overall quality of life is significant. Read more about this study
- Who is it for?
- Ages 60 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Diseases
- What is being tested?
- bucco-dental teleexpertise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 13 sitesFrance
- Study dates
- 10 Oct 2019to 25 Feb 2020
- Phase
- Interventional
- 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 60 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be resident of a facility for dependent elderly persons involved in the study
- Have given their Free, informed and signed consent
- Beneficiary or member of a social security scheme
Who cannot join
- incapacity to open the mouth
- contrary opinion of the medical team (end of life)
- Change of nursing home planned within 6 months
- Subject in a period of relative exclusion from another protocol
- Subject's participation in another study
- Subject deprived of liberty by judicial or administrative decision
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
EHPAD Le Sherpa
Belmont-sur-Rance, 12370
EHPAD Via Domitia
Castelnau-le-Lez, 34170
EHPAD Korian La Colombe
Gigean, 34770
EHPAD Korian Perier
Marseille, 13000
EHPAD La Roselière
Marsillargues, 34590
EHPAD Françoise Gauffier
Montpellier, 34000
EHPAD Korian La Pompignane
Montpellier, 34000
EHPAD La Carriera
Montpellier, 34000
EHPAD Montpellieret
Montpellier, 34000
EHPAD Pierre Laroque
Montpellier, 34000
Résidence mutualiste de Pezilla
Pezilla La Rivière, 66370
EHPAD Saint Jean
Saint-Amans-des-Cots, 12460
EHPAD Saint Jean Pla de Corts
St. Jean-Pla-de-Corts, 66490
About this study
Oral care in medical and social institutions is a real public health problem. The impact of poor oral health on the general state of residents but also on their overall quality of life is significant.
The development of a precise regulatory framework for telemedicine in France aims to transform experiments into sustainable medical activities. Odontology often set aside in this reflection, must be reintegrated. The use of tele-expertise for the oral care of nursing home residents should make it possible to replace oral health in medico-social institutions. The investigators will assess in a cluster randomized controlled study whether the buccodental telemedicine has a viable economic model and a significant impact on the overall health of facility for dependent elderly persons residents.
The medico-economic impact of the buccodental telexpertise is fundamental for the development of this innovative activity.
- Conditions
- Tooth Diseases
- Being tested
- bucco-dental teleexpertise
- Keywords
- Telemedicine, dentistry, long-term-care-home
- Medical subject headings
- Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bucco-dental teleexpertiseOther
A bucco-dental consultation remotely using telemedicine system
| Study group | Role | What they receive |
|---|---|---|
| telemedecine nursing home | Active comparator | One buccodental teleexpertise at the completion day and a second buccodental teleexpertise at the end of study Receives: Other: bucco-dental teleexpertise |
| control nursing home | No intervention | Only one buccodental teleexpertise at the end of study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-Utility ratio of buccodental telemedicine in nursing home as compared to usual care
Costs include telemedicine and medical costs related to oral health care. Utility correspond to the Quality Adjusted Life-Years (QALY) score measured using the EQ5D-3L questionnaire (EuroQol 3 levels of 5 dimensions).
Measured: At month 6
Secondary outcomes (5)
Cost/Efficacity ratio of buccodental telemedicine in nursing home as compared to usual care
Costs include telemedicine and medical costs related to oral health care.
The clinical efficacy criteria correspond to the proportion of patients with a zero dental emergency score. The score of Emergency is measured according to WHO classification:
Score "0" correspond to "unnecessary care"
Score "1" correspond to "descaling required"
Score "2" correspond to "Low urgency: need for restoration and/or crown but not immediately (superficial damage to the tooth). Includes patients requiring fixed and/or removable prostheses".
Score "3" correspond to: "Advanced emergency: need for restorations and/or crowns quickly (within 7 to 14 days) to avoid pulp damage and/or infection"
Score "4" correspond to: "High urgency: urgent need for care due to pain and/or infection. Includes patients requiring endodontic treatment or extraction"
Measured: At month 6
Quality of life comparison: EQ5D-3L questionnaire
The Quality of Life measured using the EQ5D-3L (EuroQol 3 levels of 5 dimensions) questionnaire. EQ-5D-3L questionnaire comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Levels of perceived problems are coded as follows: Level 1 (no problems) is coded as a '1' - Level 2 (some problems) is coded as a '2' - Level 3 (extreme problems) is coded as a '3'. The best score for the 5 dimensions is coded by '11111' and the worst state is coded by '33333'. In addition a EQ visual analogue scale (EQ VAS) help people say how good or bad a health state is, on which the best state is marked 100 and the worst state is marked 0.
Measured: At month 6
Economic impact of teleexpertise on dental treatment
Budgetary impact of the new coverage expressed in annual cash flows
Measured: At month 6
Evaluate satisfaction rate of use of teleexpertise of nursing home staff
Satisfaction of nursing home staff measured by an ad hoc Likert scale
Measured: At month 6
Compare the emergency score
The emergency score measured by the Oral Health Assessment Tool (OHAT) questionnaire. The OHAT comprises eight categories of screening tool to assess oral health : Lips, Tongue, Gums and tissues, Saliva, Natural teeth, Dentures, Oral cleanliness, Dental pain. After a dental examination by telemedicine, the dentist will evaluate each category as following : Score "0" correspond to "healthy", score "1" corresponds to "changes" or score "3" correspond to "unhealthy".
Measured: At month 0 and at month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start10 Oct 2019
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Why it stopped: Difficulty recruiting and follow-up due to the epidemic context of COVID19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Giraudeau, DDS, MSc, Principal investigator, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871569
- Sponsor's protocol ID
- RECHMPL18_0079
- Acronym
- e-DENT-EHPAD
- Status last verified
- Aug 2020
- First submitted
- 8 Mar 2019
- Last updated
- 27 Aug 2020
- 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 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home
- ClinicalTrials.gov ID
- NCT03871569
- Acronym / sponsor ID
- e-DENT-EHPAD / RECHMPL18_0079
- Conditions
- Tooth Diseases
- Keywords
- Telemedicine, dentistry, long-term-care-home
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting and follow-up due to the epidemic context of COVID19
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 12 Mar 2019 (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.
Oral care in medical and social institutions is a real public health problem. The impact of poor oral health on the general state of residents but also on their overall quality of life is significant.
The development of a precise regulatory framework for telemedicine in France aims to transform experiments into sustainable medical activities. Odontology often set aside in this reflection, must be reintegrated. The use of tele-expertise for the oral care of nursing home residents should make it possible to replace oral health in medico-social institutions. The investigators will assess in a cluster randomized controlled study whether the buccodental telemedicine has a viable economic model and a significant impact on the overall health of facility for dependent elderly persons residents.
The medico-economic impact of the buccodental telexpertise is fundamental for the development of this innovative activity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telemedecine nursing home | Active comparator | Other: bucco-dental teleexpertiseOne buccodental teleexpertise at the completion day and a second buccodental teleexpertise at the end of study |
| control nursing home | No intervention | –Only one buccodental teleexpertise at the end of study |
Who may qualify
- Ages
- 60 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be resident of a facility for dependent elderly persons involved in the study
- Have given their Free, informed and signed consent
- Beneficiary or member of a social security scheme
Key exclusion criteria (6 listed)
- incapacity to open the mouth
- contrary opinion of the medical team (end of life)
- Change of nursing home planned within 6 months
- Subject in a period of relative exclusion from another protocol
- Subject's participation in another study
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 |
|---|---|---|
| bucco-dental teleexpertiseA bucco-dental consultation remotely using telemedicine system | Other | telemedecine nursing home |
Primary outcome
Cost-Utility ratio of buccodental telemedicine in nursing home as compared to usual care
Time frame: At month 6
Costs include telemedicine and medical costs related to oral health care. Utility correspond to the Quality Adjusted Life-Years (QALY) score measured using the EQ5D-3L questionnaire (EuroQol 3 levels of 5 dimensions).
5 secondary outcomes
Cost/Efficacity ratio of buccodental telemedicine in nursing home as compared to usual care
Time frame: At month 6
Quality of life comparison: EQ5D-3L questionnaire
Time frame: At month 6
Economic impact of teleexpertise on dental treatment
Time frame: At month 6
Evaluate satisfaction rate of use of teleexpertise of nursing home staff
Time frame: At month 6
Compare the emergency score
Time frame: At month 0 and at month 6
Results and safety
The study was stopped early (reason given: Difficulty recruiting and follow-up due to the epidemic context of COVID19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- 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.
Nicolas Giraudeau, DDS, MSc principal investigator
CHU de Montpellier
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bucco-dental teleexpertise in people with Tooth Diseases, run by University Hospital, Montpellier at 13 sites in France.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Difficulty recruiting and follow-up due to the epidemic context of COVID19). Results are not available in the source record.
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?
Cost-Utility ratio of buccodental telemedicine in nursing home as compared to usual care (time frame: At month 6). 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 27 Aug 2020.