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| ID | Type | Description | Link |
|---|---|---|---|
| Eudra CT/ID-RCB | Other Identifier | 2024-A01176-41 |
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| Name | Class |
|---|---|
| Nantes University Hospital | OTHER |
| Assistance Publique Hopitaux De Marseille | OTHER |
| University of New Orleans | OTHER |
| Bicetre Hospital |
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PROMESS 1 is a multicenter cohort interventional study aiming at analyzing the factors associated with the risk of developing clinical arthritis among exposures or combinations of exposures in patients at risk of rheumatoid arthritis (RA), as they have high levels of anti-citrullinated peptides autoantibodies (ACPA ≥2 N).
The primary endpoint is the occurrence of clinical arthritis confirmed by ultrasound at two years of following for the subject's groups at risk of RA.
This may be explained by the following exposures or combinations of exposures: smoking, occupational exposure, physical activity, diet, hormonal exposure, drug exposure, trauma and psychological stress.
Other factors may also explain the occurrence of clinical arthritis:
This is a multicenter interventional cohort study. The goal of this cohort is to analyze the factors associated with the risk of developing clinical arthritis, considering individual or combined exposures, in patients at high risk of rheumatoid arthritis (RA).
Four groups of adults will be included:
The primary endpoint is the occurrence of clinical arthritis, confirmed by ultrasound, after two years of follow-up in the at-risk RA groups (Groups 1 & 2).
This may be explained by the following exposures or their combinations: smoking, occupational exposure, physical activity, diet, hormonal exposure, drug exposure, trauma and psychological stress...
Other factors that may contribute to the occurrence of clinical arthritis include:
The controls groups (groups 3&4) will allow for a cross-sectional analysis, comparing at-risk RA subjects with healthy individuals who share the same genetic background. They will have a single visit at baseline without follow-up.
However, the at-risk RA groups (groups 1 & 2) will have four visits (M0, M6, M12 et M24). In addition to routine care examinations performed in RA risk situations, subjects will undergo blood and stool sample collection at baseline and at one year.
All subjects regardless of group, will undergo the following baseline assessments: MRI of the dominant hand or painful hand, a lactulose absorption test (to assess intestinal permeability), hair and saliva collection, a Schirmer test, and, in some centers, an induced sputum test (to assess pulmonary mucosa). Ultrasound of the hands and feet, as well as specific questionnaires assessing the exposome, will be conducted at all visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | A total of 50 subjects will be recruited: individuals with ACPA≥2 N and clinically suspect arthralgia (CSA criteria ≥4) or those with ACPA≥N and rheumatoid factor≥2N along with clinically suspect arthralgia (CSA criteria ≥4). These subjects have an estimated 50% risk of progression to RA within 2 years. |
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| Group 2 | A total of 50 subjects will be recruited: individuals with ACPA≥2 N who do not meet the criteria for clinically suspect arthralgia (CSA criteria <4) or those with ACPA≥N and rheumatoid factor≥2N who also do not meet the criteria for clinically suspect arthralgia (CSA criteria <4). These subjects have an estimated 30% risk of progression to RA within 2 years. |
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| Group 3 | A total 25 subjects will be recruited: asymptomatic subjects (CSA criteria <4) with a family history of RA in a first-degree relative (negative controls). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood test | Biological | A total of 60 ml of blood will be collected while fasting, using the following tubes: one PAXGene Blood RNA Tube, one PAXGene Blood DNA Tube, five 5 mL serum tubes, five 5 mL EDTA tubes and one 2 mL EDTA tube for microbiota DNA analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of developing clinical arthritis | To analyze the factors associated with the risk of developing clinical arthritis confirmed by ultrasound among exposures or combinations of exposures in patients at high risk of RA. | From the baseline to the end of the follow-up at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative difference in Food Frequency Questionnaire (FFQ) between the 4 groups of subjects included, varying from never or rarely to daily or multiple times per day. | At baseline | |
| Quantitative difference in National Observatory for Physical Activity and Sedentariness -Physical Activity Questionnaire (ONAPS-PAQ) expressed in MET (Metabolic Equivalent of Task) per week between the 4 groups of subjects included. |
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Inclusion Criteria:
Exclusion Criteria:
Groupe1-2-3:
• Presence of clinical joint swelling (synovitis) at the time of inclusion and previously noted by a doctor
All groups:
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The patients will be recruted during consultation or hospitalization.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CLAIRE DAIEN, PROFESSOR | Contact | 00 33 6 85 40 27 87 | c-daien@chu-montpellier.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Montpellier | Montpellier | Hérault | 34000 | France |
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| OTHER |
| Saint Antoine University Hospital | OTHER |
| Groupe Hospitalier Pitie-Salpetriere | OTHER |
| University Hospital, Brest | OTHER |
| Assistance Publique - Hôpitaux de Paris | OTHER |
| University Hospital, Bordeaux | OTHER |
| Hôpital Cochin | OTHER |
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Blood collection:
A total of 60 ml of blood will be collected while fasting, using the following tubes: one PAXGene Blood RNA Tube, one PAXGene Blood DNA Tube, five 5 mL serum tubes, five 5 mL EDTA tubes and one 2 mL EDTA tube for microbiota DNA analysis.
Urine collection:
Urine will be collected, while fasting and after the administration of lactulose/ mannitol to assess intestinal permeability.
Stool collection:
Stool samples will be collected either at the hospital or at home using a dedicated kit.
Saliva collection:
5 ml of saliva will be collected and saliva microbiome DNA will be collected using an OMNIgene Oral kit.
Induced expectoration:
Induced sputum is collected after the inhalation of salbutamol (hypertonic aerosol).
Hair sampling:
Hair samples will be collected.
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| Group 4 | A total of 25 subjects will be recruited: individuals with RA diagnosed at polyarthritis onset (diagnosis <6 months) who have not yet been treated, with ACPA≥2 N or ACPA≥N and rheumatoid factor≥2N (positive controls). |
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| Urine test | Biological | Urine will be collected, while fasting and after the administration of lactulose/ mannitol to assess intestinal permeability. |
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| stool collection | Other | Stool samples will be collected either at the hospital or at home using a dedicated kit. |
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| saliva collection | Other | 5 ml of saliva will be collected and saliva microbiome DNA will be collected using an OMNIgene Oral kit. |
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| Induced expectoration | Other | inhalation of salbutamol, measurement of peak expiratory flow by screening spirometry (15 min later), inhalation of a hypertonic aerosol for 3 periods of 7 min. At the end of each inhalation period, the induced sputum is collected and the peak expiratory flow is measured to prevent possible bronchospasms |
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| Hair and nails sampling | Other | Hair and nails samples will be collected. |
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| Schirmer test | Other | To assess of tear secretion |
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| Ultrasound of hands and feet | Radiation | To assess the risk of RA in high-risk subjects by evaluating for synovitis, tenosynovitis, or intermetatarsal-phalangeal bursitis. |
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| MRI Contrast | Radiation | MRI of the dominant or painful hand will be performed to assess the risk of RA in high-risk subjects. |
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| Patient questions | Other | Self-questionnaires will assess factors such as ethnic origin, family history of RA, diet, physical activity, exposure to toxic substances, pollution, occupational exposures, psychological and clinical factors. |
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| Dental panoramic X-ray | Diagnostic Test | Performed as part of routine care to assess dental health |
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| Consultation with a psychologist in certain centers | Other | The short-CTQ will be completed during this consultation, only in centers offering consultations with a psychologist. |
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| Measurement of heart rate variability. | Other | The patient will wear a belt throughout the visit 1. At the end of the day, the heart rate variability data measured by the belt will be recorded in the CRF (RR interval, heart rate variability SDNN, RMSSD, and LF/HF sympathovagal balance). |
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| At baseline |
| Quantitative difference in patient-reported exposure outcome Alcohol and Substance Involvement Screening Test (ASSIST) score between the 4 groups of subjects included. | The score varies from 0 to 36 to each substance with higher score indicates greater substance-related risk and the need for stronger intervention strategies. | At baseline |
| Quantitative difference in Fagerström Test for Nicotine Dependence (FTND) score between the 4 groups of subjects included. | The score varies from 1 to 6 with higher score indicate greater nicotine dependence. | At baseline |
| Compare the exposure to pollution between the 4 groups of subjects included. "Exposure to pollution will be assessed by cross-referencing residential addresses with the Chimère database. | At baseline |
| Qualitative difference in a self-report integrated questionnaire for diagnosis of all functional gastrointestinal disorders in adults between the 4 groups of subjects included. | At baseline |
| Quantitative difference in patient-reported Francis score for Irritable Bowel Syndrome (IBS) between the 4 groups of subjects included. | The score varies from 0 to 100 with higher score means severe IBS. | At baseline |
| Qualitative difference in patient-reported clinical outcome of Sleep Apnea (Berlin questionnaire) between the 4 groups of subjects included. | It is composed of 3 categories of questions, if 2 or more categories are positive it means a high risk of apnea. | At baseline |
| Quantitative difference in Visual Analog Scale (VAS) score for patient's pain between the 4 groups of subjects included. | The score varies from 0 to 100 with higher score means worst pain possible. | At baseline |
| Quantitative difference in Visual Analog Scale (VAS) score for patient's fatigue between the 4 groups of subjects included. | The score varies from 0 to 100 with higher score means extreme fatigue. | At baseline |
| Quantitative difference in Visual Analog Scale (VAS) score for patient's disease activity between the 4 groups of subjects included. | The score varies from 0 to 100 with higher score means complete Limitation (Unable to Perform Any Activity). | At baseline |
| Quantitative difference in Visual Analog Scale (VAS) score for disease activity on the opinion of the physician between the 4 groups of subjects included. | The score varies from 0 to 100 with higher score means complete Limitation (Unable to Perform Any Activity). | At baseline |
| Quantitative difference in Pichot Fatigue Scale score between the 4 groups of subjects included. | The score varies from 0 to 32 with higher score means severe fatigue. | At baseline |
| Quantitative difference in State-Trait Anxiety Inventory (STAI) score between the 4 groups of subjects included. | The score varies from 20 to 80 with higher score means high anxiety. | At baseline |
| Quantitative difference in patient-reported outcome Posttraumatic Stress Disorder Checklist (PCL-5) score between the 4 groups of subjects included, | The score varies from 0 to 80 with higher score means very severe symptoms (Likely posttraumatic stress disorder (PTSD)). | At baseline |
| Quantitative difference in patient-reported outcome heath survey Short Form-12 (SF-12) version 2 with Physical Component Summary (PCS) and Mental Component Summary (MCS) scores between the 4 groups of subjects included | The mean is 50 for each score with a standard deviation of 10, a higher score means better health status. | At baseline |
| Quantitative difference in Insomnia Severity Index (ISI) score between the 4 groups of subjects included | The score varies from 0 to 28 with higher score means Severe insomnia. | At baseline |
| Quantitative difference in Pain Catastrophizing Scale (PCS) score between the 4 groups of subjects included | The score varies from 0 to 52 with higher score means High pain catastrophizing. | At baseline |
| Quantitative difference in Rheumatoid factor (FR) auto-antibody level between the 4 groups of subjects included. | Expressed in IU/ml (International Units per Milliliter) | At baseline |
| Quantitative difference Anti-Citrullinated Peptide Antibodies (ACPA) level between the 4 groups of subjects included. | Expressed in IU/ml (International Units per Milliliter). | At baseline |
| Quantitative difference in C-reactive protein (CRP) level between the 4 groups of subjects included. | Expressed in mg/L (milligram per liter) | At baseline |
| Quantitative difference in Neutrophils values between the 4 groups of subjects included. | Expressed in cells/µL (microliter) | At baseline |
| Quantitative difference in lymphocytes values between the 4 groups of subjects included. | Expressed in cells/µL (microliter) | At baseline |
| Quantitative difference in Platelets (PLT) between the 4 groups of subjects included. | Expressed in platelets/µL (microliter) | At baseline |
| Clinical arthritis and Clinically Suspected Arthralgias (CSA). | Assess the incidence of clinical arthritis in high-risk RA patients overall (group 1 and 2) and in subgroups according to the presence or absence of CSA and the auto-antibody profile at inclusion. The clinical arthritis is detected by the presence of joints swelling in at least 1 of the 44 joints swelling and confirmed by ultrasound. | Baseline, week 26; week 52 and week 104 visit |
| Quantitative difference in Visual Analog Scale (VAS) score for patient's pain between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | The score varies from 0 to 100 with higher score means worst pain possible. Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26; week 52 and week 104 visit |
| Quantitative difference in Visual Analog Scale (VAS) score for patient's fatigue between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | The score varies from 0 to 100 with higher score means extreme fatigue. Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26; week 52 and week 104 visit |
| Quantitative difference in Visual Analog Scale (VAS) score for patient's disease activity between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | The score varies from 0 to 100 with higher score means complete Limitation (Unable to Perform Any Activity). Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26; week 52 and week 104 visit |
| Quantitative difference in Visual Analog Scale (VAS) score for disease activity on the opinion of the physician between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | The score varies from 0 to 100 with higher score means complete Limitation (Unable to Perform Any Activity). Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26; week 52 and week 104 visit |
| Quantitative difference in Pichot Fatigue Scale score between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | The score varies from 0 to 32 with higher score means severe fatigue. Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26; week 52 and week 104 visit |
| Quantitative difference in State-Trait Anxiety Inventory (STAI) score between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | The score varies from 20 to 80 with higher score means high anxiety. Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26; week 52 and week 104 visit |
| Quantitative difference in patient-reported outcome Posttraumatic Stress Disorder Checklist (PCL-5) score between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | The score varies from 0 to 80 with higher score means very severe symptoms (Likely posttraumatic stress disorder (PTSD). Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26; week 52 and week 104 visit |
| Quantitative difference in patient-reported outcome heath survey Short Form-12 (SF-12) version 2 with Physical Component Summary (PCS) and Mental Component Summary (MCS) scores between the patients who developed clinical arthritis during the 2-year f | The mean is 50 for each score and a standard deviation of 10, a higher score means better health status. Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26; week 52 and week 104 visit |
| Quantitative difference in Insomnia Severity Index (ISI) score between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | The score varies from 0 to 28 with higher score means Severe insomnia. Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26; week 52 and week 104 visit |
| Quantitative difference in Pain Catastrophizing Scale (PCS) score between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | The score varies from 0 to 52 with higher score means High pain catastrophizing. Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26; week 52 and week 104 visit |
| Quantitative difference in tender joints count between the patients who developed clinical arthritis during the 2-year follow-up and those who did not, among 44 joints across the body. | The score varies from 0 to 44 with higher score means more active inflammatory joint disease. Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26, week 52 and week 104 visit |
| Quantitative difference in tenosynovitis count between the patients who developed clinical arthritis during the 2-year follow-up and those who did not, among 16 flexor and extensor finger's tendons. | The score varies from 0 to 44 with higher score means more active inflammatory joint disease. Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26, week 52 and week 104 visit |
| Quantitative difference in difficulties of making a fist between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26, week 52 and week 104 visit |
| Quantitative difference in tenosynovitis between the patients who developed clinical arthritis during the 2-year follow-up and those who did not detected by ultrasound. Relate this outcome to the risk of developing clinical arthritis | Baseline, week 26; week 52 and week 104 visit |
| Quantitative difference in Rheumatoid factor (FR) auto-antibody level between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | Expressed in IU/ml (International Units per Milliliter).Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26, week 52 and week 104 visit |
| Quantitative difference in Anti-Citrullinated Peptide Antibodies (ACPA) level between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | Expressed in IU/ml (International Units per Milliliter) Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26, week 52 and week 104 visit |
| Quantitative difference in C-reactive protein (CRP) level between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | Expressed in mg/L (milligram per liter) Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26, week 52 and week 104 visit |
| Quantitative difference in Neutrophils values between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | Expressed in cells/µL (microliter).Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26, week 52 and week 104 visit |
| Quantitative difference in lymphocytes values between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | Expressed in cells/µL (microliter). Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26, week 52 and week 104 visit |
| Quantitative difference in Platelets (PLT) between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | Expressed in platelets/µL (microliter), Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26, week 52 and week 104 visit |
| Proportion of patients with ultrasound synovitis in the 2 groups at high-risk of rheumatoid factor (RA) (group 1 and 2). | Detected by ultrasound in mode B and Doppler on the hand's and feet's articulations with semi-quantitative gradation according to Outcome Measures in Rheumatology (OMERACT) recommendations, between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26, week 52 and week 104 visit |
| Proportion of patients with ultrasound tenosynovitis in the 2 groups at high-risk of rheumatoid factor (RA) (group 1 and 2). | Detected by ultrasound in mode B and Doppler on the hand's and feet's articulations with semi-quantitative gradation according to Outcome Measures in Rheumatology (OMERACT) recommendations, between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. Relate this outcome to the risk of developing clinical arthritis. | Baseline, week 26, week 52 and week 104 visit |
| Proportion of patients with ultrasound synovitis in the 4 groups of subjects included. | Detected by ultrasound in mode B and Doppler on the hand's and feet's articulations with semi-quantitative gradation according to Outcome Measures in Rheumatology (OMERACT) recommendations. Relate this outcome to the risk of developing clinical arthritis. | Baseline |
| Proportion of patients with ultrasound tenosynovitis in the 4 groups of subjects included. | Detected by ultrasound in mode B and Doppler on the hand's and feet's articulations with semi-quantitative gradation according to Outcome Measures in Rheumatology (OMERACT) recommendations. Relate this outcome to the risk of developing clinical arthritis. | Baseline |
| Quantitative difference in synovitis between the 4 groups of subjects included. | Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis. | Baseline |
| Quantitative difference in bone oedemes between the 4 groups of subjects included. | Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis. | Baseline |
| Quantitative difference in pinch between the 4 groups of subjects included. | Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis. | Baseline |
| Quantitative difference in erosion between the 4 groups of subjects included. | Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis. | Baseline |
| Quantitative difference in tenosynovitis between the 4 groups of subjects included, between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis. | Baseline |
| Quantitative difference in synovitis between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis. | Baseline |
| Quantitative difference in bone oedemes between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis. | Baseline |
| Quantitative difference in pinch between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis. | Baseline |
| Quantitative difference in erosion between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis. | Baseline |
| Quantitative difference in tenosynovitis between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. | Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis. | Baseline |
| Analyzing heart rate variability as a risk factor for developing RA | Measurement of heart rate variability in high-risk patients (group 1 + group 2) for RA | Baseline |
| Analyze environmental factors associated with the risk of developing clinical arthritis. | Exposure will be assessed using partial addresses | Baseline, week 26, week 52 and week 104 visit |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| D016482 | Urinalysis |
| D017155 | Wettability |
| D011862 | Radiography, Panoramic |
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D019963 | Clinical Chemistry Tests |
| D003950 | Diagnostic Techniques, Urological |
| D057927 | Hydrophobic and Hydrophilic Interactions |
| D055598 | Chemical Phenomena |
| D013499 | Surface Properties |
| D011861 | Radiography, Dental |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D003945 | Diagnosis, Oral |
| D003813 | Dentistry |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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