Non-Insulin-Dependent Diabetes Mellitus Duration
Item
1. have self-reported type 2 diabetes of more than three months duration.
boolean
C0011860 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
2. a current hba1c value between 7.0% and 12%.
boolean
C0202054 (UMLS CUI [1])
Antidiabetics unchanged
Item
3. report no change in diabetes-related medications during the three months prior to enrollment.
boolean
C0935929 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
Age
Item
4. be at least 35 years of age.
boolean
C0001779 (UMLS CUI [1])
Natural teeth Quantity Minimum
Item
5. have at least 16 natural teeth.
boolean
C0026644 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
Chronic Periodontitis Moderate untreated | Chronic Periodontitis Severe untreated
Item
6. have moderate to severe chronic periodontitis, defined by loss of clinical attachment of >5 mm on two seperate teeth, and no treatment within six months.
boolean
C0266929 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0266929 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
Protocol Compliance
Item
7. able and willing to comply with study requirements including following instructions on study treatment and returning for follow-up visits as required by the protocol
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
8. have full understanding of all elements of, and signature and dating of the written informed consent prior to the initiation of protocol specified procedures
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Gender Sexually active Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | CONTRACEPTION NORPLANT | medroxyprogesterone acetate Injection | Depo-Provera | Vaginal Foam contraception | Female Condoms
Item
9. females with childbearing potential must have a negative pregnancy test before and during the study period. sexually active females must be using an effective form of birth control. these methods include oral contraceptives ("the pill"), an intrauterine device (iud), levonogestrol implants (norplant®), medroxyprogesterone acetate injections (depo-provera®) or contraceptive foam with a condom.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0009905 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0742782 (UMLS CUI [5])
C0065864 (UMLS CUI [6,1])
C1533685 (UMLS CUI [6,2])
C0699700 (UMLS CUI [7])
C0042254 (UMLS CUI [8,1])
C0234007 (UMLS CUI [8,2])
C0221829 (UMLS CUI [9])
Medical condition Medical Examination Difficult | Chronic disease Medical Examination Difficult | Mental condition Medical Examination Difficult | Mental condition chronic Medical Examination Difficult | Medical condition Medical Examination Invalid | Chronic disease Medical Examination Invalid | Mental condition Medical Examination Invalid | Mental condition chronic Medical Examination Invalid | Medical condition Study Subject Participation Status Excluded | Chronic disease Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded | Mental condition chronic Study Subject Participation Status Excluded
Item
1. history, or current evidence, of any significant acute or chronic medical or psychiatric condition that, in the opinion of the investigator, would render examination difficult or invalid or prevent the subject from active study participation
boolean
C3843040 (UMLS CUI [1,1])
C0582103 (UMLS CUI [1,2])
C0332218 (UMLS CUI [1,3])
C0008679 (UMLS CUI [2,1])
C0582103 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0582103 (UMLS CUI [3,2])
C0332218 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0582103 (UMLS CUI [4,3])
C0332218 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C0582103 (UMLS CUI [5,2])
C1547465 (UMLS CUI [5,3])
C0008679 (UMLS CUI [6,1])
C0582103 (UMLS CUI [6,2])
C1547465 (UMLS CUI [6,3])
C3840291 (UMLS CUI [7,1])
C0582103 (UMLS CUI [7,2])
C1547465 (UMLS CUI [7,3])
C3840291 (UMLS CUI [8,1])
C0205191 (UMLS CUI [8,2])
C0582103 (UMLS CUI [8,3])
C1547465 (UMLS CUI [8,4])
C3843040 (UMLS CUI [9,1])
C2348568 (UMLS CUI [9,2])
C2828389 (UMLS CUI [9,3])
C0008679 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C2828389 (UMLS CUI [10,3])
C3840291 (UMLS CUI [11,1])
C2348568 (UMLS CUI [11,2])
C2828389 (UMLS CUI [11,3])
C3840291 (UMLS CUI [12,1])
C0205191 (UMLS CUI [12,2])
C2348568 (UMLS CUI [12,3])
C2828389 (UMLS CUI [12,4])
Thyroid peroxidase antibody positive
Item
2. tpoab positive
boolean
C2609311 (UMLS CUI [1])
Measurement of serum thyroid stimulating hormone
Item
3. baseline serum level of tsh <0.35 or >5.5
boolean
C1277938 (UMLS CUI [1])
Antibiotic therapy
Item
4. treatment with antibiotic within the three (3) month period prior to the screening examination
boolean
C0338237 (UMLS CUI [1])
Valvular disease | Artificial Implants | Condition Systemic Requirement Antibiotic Prophylaxis
Item
5. presence of valvular disease, prosthetic implant, or any other systemic condition requiring antibiotic premedication
boolean
C3258293 (UMLS CUI [1])
C0021113 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
C0282638 (UMLS CUI [3,4])
Thyroid Disease
Item
6. history of thyroid disease
boolean
C0040128 (UMLS CUI [1])
Iodine allergy
Item
7. purported sensitivity or allergy to iodine
boolean
C0571818 (UMLS CUI [1])
Shellfish allergy
Item
8. known sensitivity or allergy to shellfish
boolean
C0577625 (UMLS CUI [1])
Autoimmune Disease | Chronic infectious disease | HIV Infection | Hepatitis
Item
9. history of autoimmune disease, or chronic infections such as hiv or hepatitis
boolean
C0004364 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0019158 (UMLS CUI [4])
Cardiovascular Disease | Myocardial Infarction | Procedure on heart | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism | Angina, Unstable | Angina at rest
Item
10. history of cardiovascular disease (heart attack or procedure within the past three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months), unstable angina pectoris or angina pectoris at rest,
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C1279986 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
C0034065 (UMLS CUI [6])
C0002965 (UMLS CUI [7])
C0152172 (UMLS CUI [8])
Kidney Disease | Creatinine measurement, serum | Gender | Dialysis
Item
11. history of renal disease: serum creatinine exceeding 1.4 mg/dl (women) or 1.5 mg/dl (men), or currently receiving dialysis.
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0011946 (UMLS CUI [4])
Mouth Diseases Gross | Periodontal Diseases | Rampant caries | Tissue damage | Oral Care Poor | Therapeutic procedure Poor Oral cavity | Soft Tissue Neoplasms | Oral hard tissue Neoplasms
Item
12. gross oral pathology (periodontal disease, rampant caries, tissue damage created by poor oral care or treatment, soft or hard tissue tumors) that, in the opinion of the investigator, could alter the treatment needs during the study
boolean
C0026636 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])
C0031090 (UMLS CUI [2])
C0399397 (UMLS CUI [3])
C0010957 (UMLS CUI [4])
C2599893 (UMLS CUI [5,1])
C0542537 (UMLS CUI [5,2])
C0087111 (UMLS CUI [6,1])
C0542537 (UMLS CUI [6,2])
C0226896 (UMLS CUI [6,3])
C0037579 (UMLS CUI [7])
C0447208 (UMLS CUI [8,1])
C0027651 (UMLS CUI [8,2])
Sign or Symptom Mucous Membrane Ulceration | Sign or Symptom Inflammatory disease of mucous membrane | Sign or Symptom Aphthous Stomatitis
Item
13. current signs or symptoms of mucosal tissue ulcerations or inflammation, or canker sores
boolean
C3540840 (UMLS CUI [1,1])
C0026724 (UMLS CUI [1,2])
C3887532 (UMLS CUI [1,3])
C3540840 (UMLS CUI [2,1])
C0333355 (UMLS CUI [2,2])
C3540840 (UMLS CUI [3,1])
C0038363 (UMLS CUI [3,2])
Orthodontic Appliances | Removable Orthodontic Appliances
Item
14. presence of orthodontic appliances or any removable appliance that impinges on the oral tissues being assessed
boolean
C0029331 (UMLS CUI [1])
C0029333 (UMLS CUI [2])
Alcohol abuse Influence Research results
Item
15. history of or current alcohol abuse that, in the opinion of the investigator, could influence the outcome of the study
boolean
C0085762 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Drug abuse
Item
16. history of, or current drug abuse
boolean
C0013146 (UMLS CUI [1])
Pharmaceutical Preparations Interferes with Research results | Antibiotics | Immunosuppressive Agents | Steroids | Anti-Inflammatory Agents, Non-Steroidal | Phenytoin | Calcium Channel Blockers | Cyclosporine | Coumadin
Item
17. use of concomitant medication that, in the opinion of the investigator, might interfere with the outcome of the study (e.g. antibiotics, immuno-suppressants, steroids, or therapeutic doses of non-steroidal anti-inflammatory agents, phenytoin, calcium antagonists, cyclosporine or coumadin)
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0003232 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0038317 (UMLS CUI [4])
C0003211 (UMLS CUI [5])
C0031507 (UMLS CUI [6])
C0006684 (UMLS CUI [7])
C0010592 (UMLS CUI [8])
C0699129 (UMLS CUI [9])
Investigational New Drugs | Investigational Medical Device
Item
18. concomitant therapy with another investigational drug or device without prior approval from the sponsor within four weeks prior to visit 2 (study day 1)
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Endodontic procedure | Periodontal Treatment | Exception Prophylactic treatment
Item
19. concomitant endodontic or periodontal therapy other than prophylaxis in the past six (6) months
boolean
C0700632 (UMLS CUI [1])
C1882340 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0199176 (UMLS CUI [3,2])
Childbearing Potential Pregnancy test positive | Pregnancy | Breast Feeding | Pregnancy Suspected | Pregnancy, Planned
Item
20. females with childbearing potential with a positive pregnancy test, pregnant or nursing mothers, suspected pregnancy, or intention to become pregnant during the study
boolean
C3831118 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0032961 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0032992 (UMLS CUI [5])
Study Subject Participation Status | Study Subject Household Same
Item
21. residence in the same household as a subject already enrolled in the study (inclusion may create blinding and/or compliance issues)
boolean
C2348568 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C0020052 (UMLS CUI [2,2])
C0445247 (UMLS CUI [2,3])
Informed Consent Unable | Informed Consent Unwilling | Protocol Compliance Unable | Protocol Compliance Unwilling
Item
22. unable and unwilling to comply with the informed consent process, to meet study requirements including following instructions on study treatment, and to return for follow-up visits as required by the protocol.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])