Dental DecayONENCT05089214
ONE-1 Oral graNd Est 1
A study testing Intra oral cameras in people with Dental Decay and Periodontal Abscess, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
This study is about the assessment of two oral telemedecine tools compared to an intra oral clinical examination used as a reference among elderly persons living in nursing home. Our hyposthesis is that the diagnostic performance of the two devices will be similar. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Decay, Periodontal Abscess, Periodontitis
- What is being tested?
- Intra oral cameras
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2022to Feb 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Be an adult person
- Be affiliated of granted of health insurance
- Be resident of a nursing home
- People (or the guardian) who received complete information about the research and who signed the consent form.
Who cannot join
- People deprived of their liberty by justice's decision, or people following psychiatric treatment according to articles L. 3212-1 et L. 3213-1 of the French law
- People with insufficient skills in French
- People with total bimaxillary prosthesis
- People without any teeth
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
EHPAD St Georges
Hannonville-sous-les-Côtes, 55210
Céline CLEMENT
About this study
Official title: Diagnostic Efficacy Assessment of Two Oral Telemedicine Tools Compared to Intra Oral Clinical Examination Used as a Reference: a Pilot Study in Region Grand-Est
This study is about the assessment of two oral telemedecine tools compared to an intra oral clinical examination used as a reference among elderly persons living in nursing home. Our hyposthesis is that the diagnostic performance of the two devices will be similar.
The main goal of the study is to assess the performances of two intra-oral cameras compared to an intra oral clinical examination to detect at least one decayed tooth.
Read more
The secondary objectives of this study are :
At patient's level:
- To assess the performances of two intra-oral cameras types compared to an intra oral clinical examination for detecting each of the following conditions: (i) at least one filled tooth, (ii) at least one missing tooth, (iii) gingivitis, (iv) an abscess, (v) dental plaque and (vi) calculous
- To assess the concordance between each intra oral cameras and the intra oral clinical examination in the evaluation of the number (i) of decayed teeth, (ii) filled teeth and (iii) missing tooth
- From video acquisitions of each intra oral cameras, to assess the inter-observer concordance for the diagnostic of each dental pathologies (presence of at least one decayed tooth, filled or missing) and periodontal (presence of gingivitis, abscess, dental plaque or scale)
- From video acquisitions of each intra oral cameras, to assess the inter-observer agreement of the number of teeth: (i) decayed, (ii) filled and (ii) missing At tooth level :
- To assess the performances of two intra-oral cameras types compared to an intra oral clinical examination for detecting each of the following conditions: (i) a cavity, (ii) a filled tooth and (iii) missing tooth In all patients :
- To assess patient's feelings about the use of each intra oral cameras
- To compare the time required for video acquisitions between each of intra oral cameras
For patients with dental or periodontal pathologies observed during the intra oral examination:
8 To assess, 2 months after initial evaluation, the proportion of patients attended dental or periodontal care and for which an appointment with a dentist has been scheduled
- Conditions
- Dental Decay, Periodontal Abscess, Periodontitis, Gingivitis, Dental Plaque, Calculus, Dental
- Being tested
- Intra oral cameras
- Keywords
- Telemedecine, Dental Camera, Nursing Home, Dental Decay, Oral Status
- Medical subject headings
- Dental Caries, Periodontal Abscess, Periodontitis, Gingivitis, Dental Plaque, Dental Calculus, Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra oral camerasDevice
Diagnostic comparison of two intra oral cameras
| Study group | Role | What they receive |
|---|---|---|
| Intra oral clinical examination | Experimental | Not described Receives: Device: Intra oral cameras |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of at least one decayed tooth in the mouth of each elderly of the study
- During the intra-oral examination (reference investigation)
- Using video records of first camera told Soprocare®
- Using video records of second camea told "wide public"
Measured: within 2 weeks
Secondary outcomes (8)
Conditions of the elderlies of the study will be evaluated thanks to the intra oral clinical examination and the video records of each of the two cameras.
The presence of at least one filled tooth, the absence of at least one tooth, the presence of gingivitis, of an abscess, of dental plaque and calculous in the elderlies of the study will be evaluated thanks to the intra oral clinical examination and the video records of each of the two cameras.
Measured: within 2 weeks
The number of decayed, filled, missing teeth in the elderly of the study will be recorded thanks to the intra oral clinical examination and the video records of each of the two cameras.
Measured: within 2 weeks
Presence of each dental conditions (at least one tooth decayed, filled, missing) and each periodontal conditions will be assess by to independent reviewers from video records of each camera.
periodontal conditions = presence of gingigivitis, abscess, dental plaque or calculous
Measured: within 2 weeks
Number of teeth showing each dental conditions (at least one tooth decayed, filled, missing) will be assess by two independent reviewers from video records of each camera.
Measured: within 2 weeks
Presence of a decayed, a filled, or missing tooth, will be assess for each tooth of elderly of the study during the clinical examination and the records of each camera.
Measured: within 2 weeks
Feeling of the patient will be evaluated thanks to a questionnaire "questionnaire of acceptability of patient's examination"
Each examination (e.g clinical exam, camera 1, camera 2) are evaluated by 8 questions rated from 1 to 6, i.e a score between 8 to 48 for each exam. The questionnaire is an adaptation of the "Whole Systems Demonstrator Service User Technology Acceptability" questionnaire from Hirani, S. P., Rixon, L., Beynon, M., Cartwright, M., Cleanthous, S., Selva, A., Sanders, C. and Newman, S. P. (2016). Quantifying beliefs regarding telehealth: Development of the Whole Systems Demonstrator Service User Technology Acceptability Questionnaire. Journal of Telemedicine and Telecare, 23(4), pp. 460-469. doi:
10.1177/1357633X16649531
Measured: within 2 weeks
Number of decayed, filled, missing teeth in the elderly of the study will be recorded thanks to the intra oral clinical examination and the video records of each of the two cameras.
Measured: within 2 weeks
Number of appointment programation
If a dental or periodontal condition has been brought to light during the intraoral clinical examination, the coordinating physician will assess by phone if the needed care have been realized during the two-month following this examination. If hasn't been realized during this two-month follow-up time, coordinating physician will record if an appointment has been programmed for this needed care.
Measured: within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start16 Jun 2022
- Primary completionDec 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental DecayStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Céline CLEMENT, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089214
- Sponsor's protocol ID
- 2021-A01306-35
- Acronym
- ONE
- Status last verified
- Jul 2022
- First submitted
- 11 Oct 2021
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Veynachter T, Sural Y, Baudot P, Remen T, Baudet A, Kabuth B, Clement C. Diagnostic performance of two teledentistry tools in elderly care facilities: the ONE-1 protocol for a pilot prospective diagnostic study. BMJ Open. 2023 Apr 3;13(4):e063906. doi: 10.1136/bmjopen-2022-063906.
PubMed 37012012
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Efficacy Assessment of Two Oral Telemedicine Tools Compared to Intra Oral Clinical Examination Used as a Reference: a Pilot Study in Region Grand-Est
- ClinicalTrials.gov ID
- NCT05089214
- Acronym / sponsor ID
- ONE / 2021-A01306-35
- Conditions
- Dental Decay, Periodontal Abscess, Periodontitis, Gingivitis, Dental Plaque, Calculus, Dental
- Keywords
- Telemedecine, Dental Camera, Nursing Home, Dental Decay, Oral Status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 22 Oct 2021 (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.
This study is about the assessment of two oral telemedecine tools compared to an intra oral clinical examination used as a reference among elderly persons living in nursing home. Our hyposthesis is that the diagnostic performance of the two devices will be similar.
The main goal of the study is to assess the performances of two intra-oral cameras compared to an intra oral clinical examination to detect at least one decayed tooth.
The secondary objectives of this study are :
At patient's level:
- To assess the performances of two intra-oral cameras types compared to an intra oral clinical examination for detecting each of the following conditions: (i) at least one filled tooth, (ii) at least one missing tooth, (iii) gingivitis, (iv) an abscess, (v) dental plaque and (vi) calculous
- To assess the concordance between each intra oral cameras and the intra oral clinical examination in the evaluation of the number (i) of decayed teeth, (ii) filled teeth and (iii) missing tooth
- From video acquisitions of each intra oral cameras, to assess the inter-observer concordance for the diagnostic of each dental pathologies (presence of at least one decayed tooth, filled or missing) and periodontal (presence of gingivitis, abscess, dental plaque or scale)
- From video acquisitions of each intra oral cameras, to assess the inter-observer agreement of the number of teeth: (i) decayed, (ii) filled and (ii) missing At tooth level :
- To assess the performances of two intra-oral cameras types compared to an intra oral clinical examination for detecting each of the following conditions: (i) a cavity, (ii) a filled tooth and (iii) missing tooth In all patients :
- To assess patient's feelings about the use of each intra oral cameras
- To compare the time required for video acquisitions between each of intra oral cameras
For patients with dental or periodontal pathologies observed during the intra oral examination:
8 To assess, 2 months after initial evaluation, the proportion of patients attended dental or periodontal care and for which an appointment with a dentist has been scheduled
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra oral clinical examination | Experimental | Device: Intra oral cameras |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Be an adult person
- Be affiliated of granted of health insurance
- Be resident of a nursing home
- People (or the guardian) who received complete information about the research and who signed the consent form.
Key exclusion criteria (4 listed)
- People deprived of their liberty by justice's decision, or people following psychiatric treatment according to articles L. 3212-1 et L. 3213-1 of the French law
- People with insufficient skills in French
- People with total bimaxillary prosthesis
- People without any teeth
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 |
|---|---|---|
| Intra oral camerasDiagnostic comparison of two intra oral cameras | Device | Intra oral clinical examination |
Primary outcome
Detection of at least one decayed tooth in the mouth of each elderly of the study
Time frame: within 2 weeks
* During the intra-oral examination (reference investigation) * Using video records of first camera told Soprocare® * Using video records of second camea told "wide public"
8 secondary outcomes
Conditions of the elderlies of the study will be evaluated thanks to the intra oral clinical examination and the video records of each of the two cameras.
Time frame: within 2 weeks
The number of decayed, filled, missing teeth in the elderly of the study will be recorded thanks to the intra oral clinical examination and the video records of each of the two cameras.
Time frame: within 2 weeks
Presence of each dental conditions (at least one tooth decayed, filled, missing) and each periodontal conditions will be assess by to independent reviewers from video records of each camera.
Time frame: within 2 weeks
Number of teeth showing each dental conditions (at least one tooth decayed, filled, missing) will be assess by two independent reviewers from video records of each camera.
Time frame: within 2 weeks
Presence of a decayed, a filled, or missing tooth, will be assess for each tooth of elderly of the study during the clinical examination and the records of each camera.
Time frame: within 2 weeks
Feeling of the patient will be evaluated thanks to a questionnaire "questionnaire of acceptability of patient's examination"
Time frame: within 2 weeks
Number of decayed, filled, missing teeth in the elderly of the study will be recorded thanks to the intra oral clinical examination and the video records of each of the two cameras.
Time frame: within 2 weeks
Number of appointment programation
Time frame: within 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: PubMed 37012012Veynachter T, Sural Y, Baudot P, Remen T, Baudet A, Kabuth B, Clement C. Diagnostic performance of two teledentistry tools in elderly care facilities: the ONE-1 protocol for a pilot prospective diagnostic study. BMJ Open. 2023 Apr 3;13(4):e063906. doi: 10.1136/bmjopen-2022-063906.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra oral cameras in people with Dental Decay and Periodontal Abscess, run by Central Hospital, Nancy, France at 1 site 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Celine CLEMENT, DDS, PhD (+ 33 6 62 73 79 47, celine.clement@univ-lorraine.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of at least one decayed tooth in the mouth of each elderly of the study (time frame: within 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05089214, which also lists 1 linked publication.
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 22 Jul 2022.