CClinicalTrials.gg
TerminatedNCT03871569e-DENT-EHPADUpdated Aug 27, 2020

Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home

An interventional study of bucco-dental teleexpertise in Tooth Diseases, sponsored by University Hospital, Montpellier. Terminated at 13 sites in France. Open to participants aged 60 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-27.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Difficulty recruiting and follow-up due to the epidemic context of COVID19
Phase
Not applicable
Study type
Interventional
Enrollment
171
Allocation
Randomized
Ages
60 Years to 120 Years
Sex
All
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Study 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.

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.

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Conditions studied

  • Tooth Diseases

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Keywords

  • Telemedicine
  • dentistry
  • long-term-care-home
03

In context

Tooth Diseases

116 studies on the registry are indexed under Tooth Diseases; 14 are open to participants now.

This study's enrollment of 171 is above the median of 46 across 82 interventional studies indexed under Tooth Diseases.

Browse Tooth Diseases studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
171 participants (actual)

Study arms

  • Active comparator
    telemedecine nursing home

    One buccodental teleexpertise at the completion day and a second buccodental teleexpertise at the end of study

    Other: bucco-dental teleexpertise

  • No intervention
    control nursing home

    Only one buccodental teleexpertise at the end of study

Interventions

  • Otherbucco-dental teleexpertise

    A bucco-dental consultation remotely using telemedicine system

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: At month 6

Secondary outcomes

  1. 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"

    Time frame: At month 6

  2. 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.

    Time frame: At month 6

  3. Economic impact of teleexpertise on dental treatment

    Budgetary impact of the new coverage expressed in annual cash flows

    Time frame: At month 6

  4. Evaluate satisfaction rate of use of teleexpertise of nursing home staff

    Satisfaction of nursing home staff measured by an ad hoc Likert scale

    Time frame: At month 6

  5. 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".

    Time frame: At month 0 and at month 6

07

Study locations

13 sites
  • EHPAD Le Sherpa
    Belmont sur Rance, 12370, France
  • EHPAD Via Domitia
    Castelnau-le-Lez, 34170, France
  • EHPAD Korian La Colombe
    Gigean, 34770, France
  • EHPAD Korian Perier
    Marseille, 13000, France
  • EHPAD La Roselière
    Marsillargues, 34590, France
  • EHPAD Françoise Gauffier
    Montpellier, 34000, France
  • EHPAD Korian La Pompignane
    Montpellier, 34000, France
  • EHPAD La Carriera
    Montpellier, 34000, France
  • EHPAD Montpellieret
    Montpellier, 34000, France
  • EHPAD Pierre Laroque
    Montpellier, 34000, France
  • Résidence mutualiste de Pezilla
    Pezilla la rivière, 66370, France
  • EHPAD Saint Jean
    Saint-Amans-des-Cots, 12460, France
  • EHPAD Saint Jean Pla de Corts
    St Jean Pla de Corts, 66490, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03871569
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Mar 12, 2019
Start date
Oct 10, 2019
Primary completion
Feb 25, 2020
Completion
Feb 25, 2020
Last update
Aug 27, 2020

Study contacts

Nicolas Giraudeau, DDS, MSc
principal investigator · CHU de Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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