Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2026-02-20 @ 1:40 PM
Study NCT ID:
NCT06387992
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
CHU de Reims
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEROdonto3D
Brief 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 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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: