Dental Care for Institutionalized Elderly PersonsGEROdonto3DNCT06387992
Evaluation of the Agreement Between a Consultation With a Nurse Acquiring Three-dimensional Intraoral Images Made With a 3D Intraoral Camera and the Standard Consultation With a Dental Surgeon, in Institutionalized Elderly Subjects
A study testing Three-dimensional dental acquisition in people with Dental Care for Institutionalized Elderly Persons, run by CHU de Reims at 1 site in France.
Trial summary
The primary objective of this study will be to assess the agreement between a dental consultation with a nurse acquiring intraoral images, using a 3D intraoral camera, and a standard consultation with a dental surgeon, in institutionalized elderly subjects Institutionalized subjects planned to have a dental… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Care for Institutionalized Elderly Persons
- What is being tested?
- Three-dimensional dental acquisition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients institutionalized in one of the nursing homes of the Champagne University Hospital Group in Reims
- Patients who are able to understand and answer questions
- Patients with a planned consultation in the Oral Medicine department of the Reims University Hospital
- Patients affiliated to social security
- Fluent in French
- Patients agreeing to participate in the study
Who cannot join
- Patients who are unable to understand and answer questions
- Totally edentulous patients
- Patients not transportable according to the geriatrician's assessment
- Persons deprived of their liberty by a judicial or administrative decision
- Patients already followed at the Oral Medicine department of the Reims University Hospital
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Damien JOLLY
Reims
Carole ETIENNOT, 03 10 73 66 79 ext. 0033, cetiennot@chu-reims.fr
About this study
The primary objective of this study will be to assess the agreement between a dental consultation with a nurse acquiring intraoral images, using a 3D intraoral camera, and a standard consultation with a dental surgeon, in institutionalized elderly subjects Institutionalized subjects planned to have a dental consultation and eligible will be included once written informed consent is signed. Their dental consultation will start with a consultation with a nurse to record 3D intraoral images, then a consultation with a dental surgeon for standard dental care, blinded from the nurse consultation will be performed. Thereafter, 3D images will be analyzed by another dental surgeon blinded from the results of both consultations. Agreement on different outcomes between the analysis of the images acquired by the nurse and the standard dental evaluation by a dental surgeon will be assessed.
Agreement on the results between the interpretation of the 3D images acquired by a nurse and the standard consultation by a dental surgeon could lead, in the long term, to a significant step forward in dental care of institutionalized patients.
Indeed, training nursing home nurses to acquire 3D dental images would enable the identification of patients in need of immediate dental care and thus extend the possibilities of access to consultations with a dentist for these patients. This would increase the efficiency of care.
Read the detailed description
Participation in the study will be offered to any eligible patient in his nursing home prior to his dental consultation. If the patient agrees to participate in the research, he will be included in the study after signing informed consent.
For the included patients, one dental consultation will be planned and organized within the Oral Medicine Unit of the Reims University Hospital. The consultation will be divided into 3 different parts (2 consultations + images analysis):
- 1st part: a consultation with a trained nurse who will perform a three-dimensional dental acquisition using a 3D intraoral camera and who will help the patient complete the General Oral Health Assessment Index (GOHAI)
- 2nd part: a consultation with a dental surgeon, different from the one who analyzes the images. He will perform a standard dental consultation, blinded to the results of the nurse dental consultation.
- 3rd part (without the patient): the three-dimensional images will be interpreted by a dental surgeon (the same for all patients included) blinded to the results of the consultations, in order to obtain the evaluation of the different outcomes. This last step will not require the presence of the patient and can be carried out later.
Participation in the study will not change the patient's dental care.
- Being tested
- Three-dimensional dental acquisition
- Keywords
- Dental care, oral health, teledentistry, older adults, nursing home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional dental acquisitionOther
Consultation with a trained nurse who will perform a three-dimensional dental acquisition using a 3D intraoral camera
| Study group | Role | What they receive |
|---|---|---|
| Three-dimensional dental acquisition by a nurse | Experimental | Consultation with a trained nurse who will perform a three-dimensional dental acquisition using a 3D intraoral camera Receives: Other: Three-dimensional dental acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
DMFT index
During dental consultation with a dental surgeon and during the analysis of the 3D images DMFT index (Klein and Palmer, 1940). The index will be assessed from the 3D intraoral images acquired during the nurse consultation and from the standard dental consultation performed by a dental surgeon.
The DMFT index describes, excluding third molars, the number of teeth:
- D : Decayed
- M : missing
- FT : Filled Teeth The score represents the sum of missing, decayed and/or filled teeth in the same individual. Third molars are not taken into account in the calculation of this score.
Measured: Day 1
Secondary outcomes (2)
Plaque control record
During dental consultation with a dental surgeon and during the analysis of the 3D images Plaque control record (O'Leary et al., 1973). The index will be assessed from the 3D intraoral images acquired during the nurse consultation and from the standard dental consultation performed by a dental surgeon.
This index records the presence of supragingival plaque on all four tooth surfaces. The result is expressed as a percentage of the number of surfaces with plaque on the total number of faces
Measured: Day 1
General Oral Health Assessment Index (GOHAI)
During the consultation with the nurse The GOHAI assesses self-perceived oral health in older people. It is composed of 12 questions about pain and discomfort, dysfunctions and psychosocial impacts of dental problems.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Care for Institutionalized Elderly PersonsStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387992
- Sponsor's protocol ID
- PP24023
- Acronym
- GEROdonto3D
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Agreement Between a Consultation With a Nurse Acquiring Three-dimensional Intraoral Images Made With a 3D Intraoral Camera and the Standard Consultation With a Dental Surgeon, in Institutionalized Elderly Subjects
- ClinicalTrials.gov ID
- NCT06387992
- Acronym / sponsor ID
- GEROdonto3D / PP24023
- Keywords
- Dental care, oral health, teledentistry, older adults, nursing home
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Apr 2024 (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.
The primary objective of this study will be to assess the agreement between a dental consultation with a nurse acquiring intraoral images, using a 3D intraoral camera, and a standard consultation with a dental surgeon, in institutionalized elderly subjects Institutionalized subjects planned to have a dental consultation and eligible will be included once written informed consent is signed. Their dental consultation will start with a consultation with a nurse to record 3D intraoral images, then a consultation with a dental surgeon for standard dental care, blinded from the nurse consultation will be performed. Thereafter, 3D images will be analyzed by another dental surgeon blinded from the results of both consultations. Agreement on different outcomes between the analysis of the images acquired by the nurse and the standard dental evaluation by a dental surgeon will be assessed.
Agreement on the results between the interpretation of the 3D images acquired by a nurse and the standard consultation by a dental surgeon could lead, in the long term, to a significant step forward in dental care of institutionalized patients.
Indeed, training nursing home nurses to acquire 3D dental images would enable the identification of patients in need of immediate dental care and thus extend the possibilities of access to consultations with a dentist for these patients. This would increase the efficiency of care.
Detailed description
Participation in the study will be offered to any eligible patient in his nursing home prior to his dental consultation. If the patient agrees to participate in the research, he will be included in the study after signing informed consent.
For the included patients, one dental consultation will be planned and organized within the Oral Medicine Unit of the Reims University Hospital. The consultation will be divided into 3 different parts (2 consultations + images analysis):
- 1st part: a consultation with a trained nurse who will perform a three-dimensional dental acquisition using a 3D intraoral camera and who will help the patient complete the General Oral Health Assessment Index (GOHAI)
- 2nd part: a consultation with a dental surgeon, different from the one who analyzes the images. He will perform a standard dental consultation, blinded to the results of the nurse dental consultation.
- 3rd part (without the patient): the three-dimensional images will be interpreted by a dental surgeon (the same for all patients included) blinded to the results of the consultations, in order to obtain the evaluation of the different outcomes. This last step will not require the presence of the patient and can be carried out later.
Participation in the study will not change the patient's dental care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three-dimensional dental acquisition by a nurse | Experimental | Other: Three-dimensional dental acquisitionConsultation with a trained nurse who will perform a three-dimensional dental acquisition using a 3D intraoral camera |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients institutionalized in one of the nursing homes of the Champagne University Hospital Group in Reims
- Patients who are able to understand and answer questions
- Patients with a planned consultation in the Oral Medicine department of the Reims University Hospital
- Patients affiliated to social security
- Fluent in French
Key exclusion criteria (5 listed)
- Patients who are unable to understand and answer questions
- Totally edentulous patients
- Patients not transportable according to the geriatrician's assessment
- Persons deprived of their liberty by a judicial or administrative decision
- Patients already followed at the Oral Medicine department of the Reims University Hospital
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 |
|---|---|---|
| Three-dimensional dental acquisitionConsultation with a trained nurse who will perform a three-dimensional dental acquisition using a 3D intraoral camera | Other | Three-dimensional dental acquisition by a nurse |
Primary outcome
DMFT index
Time frame: Day 1
During dental consultation with a dental surgeon and during the analysis of the 3D images DMFT index (Klein and Palmer, 1940). The index will be assessed from the 3D intraoral images acquired during the nurse consultation and from the standard dental consultation performed by a dental surgeon. The DMFT index describes, excluding third molars, the number of teeth: * D : Decayed * M : missing * FT : Filled Teeth The score represents the sum of missing, decayed and/or filled teeth in the same individual. Third molars are not taken into account in the calculation of this score.
2 secondary outcomes
Plaque control record
Time frame: Day 1
General Oral Health Assessment Index (GOHAI)
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-dimensional dental acquisition in people with Dental Care for Institutionalized Elderly Persons, run by CHU de Reims 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carole ETIENNOT (03 10 73 66 79 ext. 0033, cetiennot@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DMFT index (time frame: Day 1). 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 29 Apr 2024.