Diabetes ComplicationsPARODIABNOSTICNCT05890807
Concordance in Diagnosis of Periodontitis in Diabetic Patients Between an Indirect Method Based on a Photograph of the Oral Cavity and a Direct Method Based on the Clinical Examination of This Oral Cavity (Reference).
A study testing Front view photography of the patient's oral cavity with the help of a smartphone in the diabetology department. in people with Diabetes Complications and Periodontal Diseases, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Periodontitis, a known complication of diabetes, is an infectious disease that destroys bone and gums. Studies have shown that diabetes favors periodontitis, and that periodontitis contributes to its aggravation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Complications, Periodontal Diseases
- What is being tested?
- Front view photography of the patient's oral cavity with the help of a smartphone in the diabetology department.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2023to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 1 or 2 diabetes.
- Patients of legal age (≥ 18 years).
- Patient undergoing day or weekday hospitalization in the Metabolic and Endocrine Diseases Department at Nîmes University Hospital.
- Patient who has not reported his or her opposition to participating in the study.
- Patient affiliated or beneficiary of a health insurance plan.
Who cannot join
- Patient who has received treatment for periodontal disease within the past 12 months.
- Patient with fewer (<) than 3 functional contiguous teeth.
- Patient participating in research involving human subjects defined as category 1.
- Patient in an exclusion period as determined by another study.
- Patient under court protection, guardianship, or conservatorship.
- Patient for whom informed information cannot be provided.
- Patient who is pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Concordance in the Diagnosis of Periodontitis in Diabetic Patients Between an Indirect Method Based on a Photograph of the Oral Cavity and a Direct Method Based on the Clinical Examination of This Oral Cavity (Reference).
Periodontitis, a known complication of diabetes, is an infectious disease that destroys bone and gums. Studies have shown that diabetes favors periodontitis, and that periodontitis contributes to its aggravation. The positive impact of treating periodontitis on the cost of diabetes care has been demonstrated and the French national health system fully covers the treatment of periodontitis for diabetic patients. Unfortunately, 80% of diabetic patients do not visit their dentist enough.
Although diabetologists regularly see their patients and are aware of the importance of treating periodontitis,they do not have the expertise to diagnose the condition whereas a specialist dentist can often diagnose it just by looking.
Read more
This study aims to develop a solution combining the dentist's expertise with that of the diabetologist. This would be based on analysis of a photograph of the patient's oral cavity, taken in the department. So far, no studies have ever evaluated the performance of an expert dentist for diagnosing periodontitis from a simple photograph made by non-dental experts in a diabetic department.
The hypothesis is that the concordance in the diagnosis of periodontitis between an indirect method based on a photograph of the oral cavity and a direct method based on clinical examination of this oral cavity (reference) in the diabetic patient would be satisfactory.
Read the detailed description
Among the complications of diabetes, periodontitis, an infectious disease that destroys the bone and gums, has a bidirectional relationship with diabetes. Indeed, studies have shown that diabetes favors periodontitis, and that periodontitis contributes to the aggravation of diabetes. In addition, the positive impact of treating periodontitis on the indicators and cost of diabetes management has been demonstrated. To echo these findings, since 2020, the French national health scheme now fully covers the treatment of periodontitis in diabetic patients. Unfortunately, health insurance reports point out that 80% of diabetic patients do not visit their dentist enough.
This makes it difficult to detect and treat periodontitis in diabetic patients at an early stage. At the same time, diabetologists who regularly see their patients confirm the importance of knowing their periodontal condition. But they do not have the expertise to diagnose periodontitis whereas, in most cases, a specialist dentist could diagnose it just by looking. The development of a solution allowing the dentist's expertise to be brought to the service of diabetes may have a positive impact on the management of diabetic patients with periodontitis. This expertise could be based on analyzing a photograph of the patient's oral cavity, taken in the department. So far, no studies have ever evaluated the performance of an expert dentist for diagnosing periodontitis from a simple photograph, made by non-dental experts in a diabetic department.
The hypothesis is that the concordance in the diagnosis of periodontitis between an indirect method based on a photograph of the oral cavity and a direct method based on clinical examination of this oral cavity (reference) in the diabetic patient would be satisfactory.
- Conditions
- Diabetes Complications, Periodontal Diseases
- Being tested
- Front view photography of the patient's oral cavity with the help of a smartphone in the diabetology department.
- Keywords
- Diabetes, Periodontitis
- Medical subject headings
- Diabetes Complications, Periodontal Diseases, Diabetes Mellitus, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Front view photography of the patient's oral cavity with the help of a smartphone in the diabetology department.Diagnostic test
The diabetologist will take a photograph of the patient's oral cavity in the diabetology department.
| Study group | Role | What they receive |
|---|---|---|
| Patients whose oral cavity will be photographed in the diabetology department | Experimental | The patient is seated in the chair. The trained staff member positions the mouth guard and takes a frontal photograph of the patient's oral cavity using the photo sensor (smart-phone). Only the oral cavity will be visible in the photograph and there will be no possibility for an external assessor to recognize the patient's face. Receives: Diagnostic Test: Front view photography of the patient's oral cavity with the help of a smartphone in the diabetology department. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parodontitis based on a photograph of the patient's oral cavity (indirect method)
For the indirect method, two expert dentists will independently analyze the photographs in order to decide whether YES / NO the patient has parodontitis.
Measured: Day 0 to day 7
Parodontitis based on clinical observation of the patient's oral cavity (direct method)
For the direct method by clinical examination, an expert dentist different from those involved in the indirect method will decide whether YES / NO the patient has parodontitis.
Measured: Day 0
Secondary outcomes (30)
A. Sensitivity and specificity of the Positive Predictive Value (NPV) measured by the indirect method
Positive predictive value = True Positive / (True Positives+False Positives)
Measured: Day 0 to day 7
A. Sensitivity and specificity of the Negative Predictive Value (NPV) measured by the indirect method
Negative predictive value = True Negative / (False Negatives + True Negatives)
Measured: Day 0 to day 7
A. Sensitivity and specificity of the Positive Predictive Value (PPV) measured by the direct method
Positive predictive value = True Positive / (True Positives+False Positives)
Measured: Day 0
A. Sensitivity and specificity of the Positive Predictive Value (PPV) measured by the indirect method
Negative predictive value = True Negative / (False Negatives+True Negatives)
Measured: Day 0 to day 7
B. Quality of photographs taken by the diabetology department : respect of anonymity
Evaluation of the photograph by two expert dentists who check compliance with the rules established for taking the photo.
During the research or at its conclusion, the data collected on the persons who lend themselves to it and transmitted to the sponsor by the investigators (or any other specialized intervening parties) will be made anonymous. Under no circumstances will the names of the persons concerned or their addresses appear in clear text. The patient will be identified only by a unique seven-digit identification number. A list of subject identifications will be kept in the investigator's file. The investigator will ensure that the anonymity of each individual participating in the study is guaranteed. No identifying information will be given to any third party other than those who are authorized by law to hold such information (and who are bound by professional secrecy).
Measured: Day 0 to day 7
B. Quality of photographs taken by the diabetology department : visibility of the gums
Two expert dentists will check compliance with the rules established for taking the photo. For sufficient diagnostic quality, the gums must be clearly visible. "Periodontal disease" describes all gingivitis and periodontitis. Gingivitis is characterized by gingival inflammation manifested by redness of the gums, bleeding and localized edema. The inflammatory process only affects the superficial periodontium (gingival epithelium and gingival connective tissue) and is most often due to an accumulation of bacterial plaque. However, it can be reversed with specific oral hygiene measures. When the deep periodontal tissues (alveolar bone, periodontal ligament, cementum) are affected it is called periodontitis. These lesions are clinically characterized by gingival inflammation and a periodontal pocket (space that is created between the tooth and the gum) as well as by bone loss.
Measured: Day 0 to day 7
B. Quality of photographs taken by the diabetology department : image sharpness
Evaluation of the photograph by two expert dentists who check compliance with the rules established for taking the photo. Is the image sharpness good enough to clearly visualize the patient's gums? YES/NO
Measured: Day 0 to day 7
B. Quality of photographs taken by the diabetology department : use of the flash
Evaluation of the photograph by two expert dentists who check compliance with the rules established for taking the photo. Was the flash used ? YES/NO
Measured: Day 0 to day 7
B. Quality of photographs taken by the diabetology department : absence of zoom
Evaluation of the photograph by two expert dentists who check compliance with the rules established for taking the photo.Was the zoom used? YES/NO
Measured: Day 0 to day 7
B. Quality of photographs taken by the diabetology department : orientation
Evaluation of the photograph by two expert dentists who check compliance with the rules established for taking the photo. Was the photo taken from full front view ? YES/NO
Measured: Day 0 to day 7
B. Percentage of photographs meeting all of the above criteria for acceptance
The number of photographs that meet all the above acceptance criteria will be converted into a percentage.
Measured: Day 0 to day 7
C. Association between the patient's diabetic constants and his/her periodontal status. Hospitalization
Diabetic findings according to the following criteria recorded for each patient included:
- the type of hospitalization (day or week)
Measured: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Type of diabetes
Diabetic findings according to the following criteria recorded for each patient included:
-the type of diabetes (Type I, Type II or other)
Measured: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Age of diabetes
Diabetic findings according to the following criteria recorded for each patient included:
- Age of diabetes: <1 year, 1-5 years, 5-10 years, 10-20 years, >20 years
Measured: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Treatment
Diabetic findings according to the following criteria recorded for each patient included:
-treatment: insulin therapy yes/no and the drug used (metformin, hypoglycemic sulfonamides, dipeptidyl peptidase IV inhibitors, SGLT2 inhibitors, GLP1 analogues, other) will be recorded.
Measured: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status.HbA1c level
Diabetic findings according to the following criteria recorded for each patient included:
- the patient's HbA1c level will be recorded in mmol/mol
Measured: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Macrovascular complications
Diabetic findings according to the following criteria recorded for each patient included:
-Presence of macrovascular complications will be recorded as YES/NO
Measured: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Type of macrovascular complication
Diabetic findings according to the following criteria recorded for each patient included:
-The type of macrovascular complication : arteriopathy (cerebral, coronary, lower limbs) will be recorded
Measured: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Microvascular complications
Diabetic findings according to the following criteria recorded for each patient included:
-presence of microvascular complications, YES/NO
Measured: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Type of microvascular complication
Diabetic findings according to the following criteria recorded for each patient included:
-The type of microvascular complication (retinopathy, nephropathy, neuropathy) will be recorded
Measured: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Smoking
Diabetic findings according to the following criteria recorded for each patient included:
- the patient's smoking status (active/number of cigarettes per day/ex-smoker) will be recorded
Measured: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Periodontitis
Diabetic findings according to the following criteria recorded for each patient included:
Presence of periodontitis (yes/no) according to the reference method, i.e. by odontological examination.
Measured: Day 0
D. Visible clinical signs associated with periodontitis on the photos taken. Inflammation
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination):
-Inflammatory color of the gum The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period.
Observation of the photographs by two expert dentists.
Measured: Day 0 to day 7
D. Visible clinical signs associated with periodontitis on the photos taken. Root tartar
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination):
-Root tartar The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period.
Observation of the photographs by two expert dentists.
Measured: Day 0 to day 7
D. Visible clinical signs associated with periodontitis on the photos taken. Pus
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination):
-Pus The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period.
Observation of the photographs by two expert dentists.
Measured: Day 0 to day 7
D. Visible clinical signs associated with periodontitis on the photos taken. Bleeding
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination):
-Bleeding The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period.
Observation of the photographs by two expert dentists.
Measured: Day 0 to day 7
D. Visible clinical signs associated with periodontitis on the photos taken. Interdental space
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination):
-Interdental space The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period.
Observation of the photographs by two expert dentists.
Measured: Day 0 to day 7
D. Visible clinical signs associated with periodontitis on the photos taken. Gum retraction
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination):
-Retraction of the gum The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period.
Observation of the photographs by two expert dentists.
Measured: Day 0 to day 7
D. Visible clinical signs associated with periodontitis on the photos taken. Swollen gums
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination):
-Gum swelling The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period.
Observation of the photographs by two expert dentists.
Measured: Day 0 to day 7
D. Visible clinical signs associated with periodontitis on the photos taken. Plaque
Evaluation of clinical signs visible on the photos of diabetic patients diagnosed with periodontitis according to the gold standard (odontological examination):
-Dental plaque The evaluation will be interpreted by two blinded expert dentists (different from the one who performed the odontological examination) at the end of the inclusion period.
Observation of the photographs by two expert dentists.
Measured: Day 0 to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start20 Mar 2023
- Primary completion29 Feb 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Model description
- A prospective, single-center, open-label, cross-sectional study to evaluate the concordance of an intervention versus the "gold standard.
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890807
- Sponsor's protocol ID
- 2022-A02129-34
- Acronym
- PARODIABNOSTIC
- Status last verified
- Mar 2025
- First submitted
- 15 May 2023
- Last updated
- 7 Mar 2025
- 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 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Concordance in the Diagnosis of Periodontitis in Diabetic Patients Between an Indirect Method Based on a Photograph of the Oral Cavity and a Direct Method Based on the Clinical Examination of This Oral Cavity (Reference).
- ClinicalTrials.gov ID
- NCT05890807
- Acronym / sponsor ID
- PARODIABNOSTIC / 2022-A02129-34
- Conditions
- Diabetes Complications, Periodontal Diseases
- Keywords
- Diabetes, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Jun 2023 (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.
Periodontitis, a known complication of diabetes, is an infectious disease that destroys bone and gums. Studies have shown that diabetes favors periodontitis, and that periodontitis contributes to its aggravation. The positive impact of treating periodontitis on the cost of diabetes care has been demonstrated and the French national health system fully covers the treatment of periodontitis for diabetic patients. Unfortunately, 80% of diabetic patients do not visit their dentist enough.
Although diabetologists regularly see their patients and are aware of the importance of treating periodontitis,they do not have the expertise to diagnose the condition whereas a specialist dentist can often diagnose it just by looking.
This study aims to develop a solution combining the dentist's expertise with that of the diabetologist. This would be based on analysis of a photograph of the patient's oral cavity, taken in the department. So far, no studies have ever evaluated the performance of an expert dentist for diagnosing periodontitis from a simple photograph made by non-dental experts in a diabetic department.
The hypothesis is that the concordance in the diagnosis of periodontitis between an indirect method based on a photograph of the oral cavity and a direct method based on clinical examination of this oral cavity (reference) in the diabetic patient would be satisfactory.
Detailed description
Among the complications of diabetes, periodontitis, an infectious disease that destroys the bone and gums, has a bidirectional relationship with diabetes. Indeed, studies have shown that diabetes favors periodontitis, and that periodontitis contributes to the aggravation of diabetes. In addition, the positive impact of treating periodontitis on the indicators and cost of diabetes management has been demonstrated. To echo these findings, since 2020, the French national health scheme now fully covers the treatment of periodontitis in diabetic patients. Unfortunately, health insurance reports point out that 80% of diabetic patients do not visit their dentist enough.
This makes it difficult to detect and treat periodontitis in diabetic patients at an early stage. At the same time, diabetologists who regularly see their patients confirm the importance of knowing their periodontal condition. But they do not have the expertise to diagnose periodontitis whereas, in most cases, a specialist dentist could diagnose it just by looking. The development of a solution allowing the dentist's expertise to be brought to the service of diabetes may have a positive impact on the management of diabetic patients with periodontitis. This expertise could be based on analyzing a photograph of the patient's oral cavity, taken in the department. So far, no studies have ever evaluated the performance of an expert dentist for diagnosing periodontitis from a simple photograph, made by non-dental experts in a diabetic department.
The hypothesis is that the concordance in the diagnosis of periodontitis between an indirect method based on a photograph of the oral cavity and a direct method based on clinical examination of this oral cavity (reference) in the diabetic patient would be satisfactory.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, single-center, open-label, cross-sectional study to evaluate the concordance of an intervention versus the "gold standard.
| Arm | Type | Receives |
|---|---|---|
| Patients whose oral cavity will be photographed in the diabetology department | Experimental | Diagnostic Test: Front view photography of the patient's oral cavity with the help of a smartphone in the diabetology department.The patient is seated in the chair. The trained staff member positions the mouth guard and takes a frontal photograph of the patient's oral cavity using the photo sensor (smart-phone). Only the oral cavity will be visible in the photograph and there will be no possibility for an external assessor to recognize the patient's face. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with type 1 or 2 diabetes.
- Patients of legal age (≥ 18 years).
- Patient undergoing day or weekday hospitalization in the Metabolic and Endocrine Diseases Department at Nîmes University Hospital.
- Patient who has not reported his or her opposition to participating in the study.
- Patient affiliated or beneficiary of a health insurance plan.
Key exclusion criteria (7 listed)
- Patient who has received treatment for periodontal disease within the past 12 months.
- Patient with fewer (<) than 3 functional contiguous teeth.
- Patient participating in research involving human subjects defined as category 1.
- Patient in an exclusion period as determined by another study.
- Patient under court protection, guardianship, or conservatorship.
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 |
|---|---|---|
| Front view photography of the patient's oral cavity with the help of a smartphone in the diabetology department.The diabetologist will take a photograph of the patient's oral cavity in the diabetology department. | Diagnostic test | Patients whose oral cavity will be photographed in the diabetology department |
Primary outcome
Parodontitis based on a photograph of the patient's oral cavity (indirect method)
Time frame: Day 0 to day 7
For the indirect method, two expert dentists will independently analyze the photographs in order to decide whether YES / NO the patient has parodontitis.
Parodontitis based on clinical observation of the patient's oral cavity (direct method)
Time frame: Day 0
For the direct method by clinical examination, an expert dentist different from those involved in the indirect method will decide whether YES / NO the patient has parodontitis.
30 secondary outcomes
A. Sensitivity and specificity of the Positive Predictive Value (NPV) measured by the indirect method
Time frame: Day 0 to day 7
A. Sensitivity and specificity of the Negative Predictive Value (NPV) measured by the indirect method
Time frame: Day 0 to day 7
A. Sensitivity and specificity of the Positive Predictive Value (PPV) measured by the direct method
Time frame: Day 0
A. Sensitivity and specificity of the Positive Predictive Value (PPV) measured by the indirect method
Time frame: Day 0 to day 7
B. Quality of photographs taken by the diabetology department : respect of anonymity
Time frame: Day 0 to day 7
B. Quality of photographs taken by the diabetology department : visibility of the gums
Time frame: Day 0 to day 7
B. Quality of photographs taken by the diabetology department : image sharpness
Time frame: Day 0 to day 7
B. Quality of photographs taken by the diabetology department : use of the flash
Time frame: Day 0 to day 7
B. Quality of photographs taken by the diabetology department : absence of zoom
Time frame: Day 0 to day 7
B. Quality of photographs taken by the diabetology department : orientation
Time frame: Day 0 to day 7
B. Percentage of photographs meeting all of the above criteria for acceptance
Time frame: Day 0 to day 7
C. Association between the patient's diabetic constants and his/her periodontal status. Hospitalization
Time frame: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Type of diabetes
Time frame: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Age of diabetes
Time frame: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Treatment
Time frame: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status.HbA1c level
Time frame: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Macrovascular complications
Time frame: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Type of macrovascular complication
Time frame: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Microvascular complications
Time frame: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Type of microvascular complication
Time frame: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Smoking
Time frame: Day 0
C. Association between the patient's diabetic constants and his/her periodontal status. Periodontitis
Time frame: Day 0
D. Visible clinical signs associated with periodontitis on the photos taken. Inflammation
Time frame: Day 0 to day 7
D. Visible clinical signs associated with periodontitis on the photos taken. Root tartar
Time frame: Day 0 to day 7
D. Visible clinical signs associated with periodontitis on the photos taken. Pus
Time frame: Day 0 to day 7
D. Visible clinical signs associated with periodontitis on the photos taken. Bleeding
Time frame: Day 0 to day 7
D. Visible clinical signs associated with periodontitis on the photos taken. Interdental space
Time frame: Day 0 to day 7
D. Visible clinical signs associated with periodontitis on the photos taken. Gum retraction
Time frame: Day 0 to day 7
D. Visible clinical signs associated with periodontitis on the photos taken. Swollen gums
Time frame: Day 0 to day 7
D. Visible clinical signs associated with periodontitis on the photos taken. Plaque
Time frame: Day 0 to day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Front view photography of the patient's oral cavity with the help of a smartphone in the diabetology department. in people with Diabetes Complications and Periodontal Diseases, run by Centre Hospitalier Universitaire de Nīmes 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 7 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Parodontitis based on a photograph of the patient's oral cavity (indirect method) (time frame: Day 0 to day 7). The study lists 2 primary outcomes in all. 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 7 Mar 2025.