Health Condition 1: K053- Chronic periodontitis
Conditions
Interventions
Intervention1: Full mouth disinfection (FMD): - Administration of local anesthesia [lidocaine (1%) with epinephrine], if needed.
- Full mouth scaling and root planing with hand and ultrasonic instrume
Sponsors
Department of Periodontology, Government Dental College and Hospital, Nagpur
Eligibility
Inclusion criteria
Inclusion criteria: 1. Stage II or Stage III Periodontitis subjects not at risk of ASCVD with CIMT = 0.6 mm or elevated cardiovascular risk biomarkers. Stage II Periodontitis – Moderate Periodontitis with Clinical Attachment Loss of 3 to 4 mm, Maximum probing depth =5 mm, mostly horizontal bone loss in Coronal third (15% to 33%). Extent and distribution – Generalized. Stage III Periodontitis - Severe Periodontitis with Clinical Attachment Loss of =5 mm, Radiographic bone loss extending to mid-third of root and beyond, Probing depth =6 mm, Vertical bone loss =3 mm, Furcation involvement Class II or III, Moderate ridge defect. Extent and distribution – Generalized. 2. Stage II or Stage III Periodontitis subjects at risk of ASCVD with Borderline - high cholesterol or pre – hypertensive or prediabetic with CIMT = 0.6 mm or elevated cardiovascular risk biomarkers. 3. Have at least 16 natural teeth excluding third molars. Prehypertensive/ High – normal Blood Pressure (BP) - Subjects with systolic BP of 130-139 mmHg or diastolic BP of 85-89 mmHg. 2. Borderline - high cholesterol - Total serum cholesterol levels between 200 – 239 mg/dl or LDL (Low Density Lipoprotein) levels between 130 – 159 mg/dl. 3. Pre-diabetes - Subjects with prediabetes are defined by the presence of Fasting Plasma Glucose (FPG) 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) Impaired Fasting Glucose (IFG) and/or HbA1c 39 – 46 mmol/ mol (5.7-6.4 %). 4. Provide informed consent and willingness to cooperate with the study protocol
Exclusion criteria
Exclusion criteria: 1. Treatment with antihypertensive, antilipemic, antiarrhythmic, anti-platelet therapy and other cardiovascular drugs. 2. Systemic diseases such as HIV/AIDS, liver disease, chronic renal failure, tuberculosis, autoimmune diseases, any mental disability. 3. Previous history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, AV blockade, peripheral vascular disease, and cerebrovascular accident. 4. Subjects with hypercholesteremia, Diabetes Mellitus, Obesity, Smokers. 5. Oral/ Dental infections other than periodontal infections. 6. Subjects who received periodontal treatment within the last 6 months. 7. Subjects who require antibiotic prophylaxis before examination or treatment. 8. Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Carotid Intima Media Thickness (c-IMT) 2. Endocan/ Endothelium Specific Molecule – 1 (ESM-1) 3. Platelet Indices 4. Highly sensitive C-reactive protein (hs - CRP) in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis.Timepoint: Baseline, 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood Pressure (BP) in Prehypertensive Stage II or Stage III Periodontitis subjectsTimepoint: Baseline, 3, 6, 9 and 12 months;Lipid Profile in Borderline - high cholesterol Stage II or Stage III Periodontitis subjectsTimepoint: Baseline, 3,6,9 and 12 months;blood glucose level in prediabetic Stage II or Stage III Periodontitis subjectsTimepoint: Baseline, 3,6,9 and 12 months;Bleeding on Probing (BOP)in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis.Timepoint: Baseline, 3,6,9 and 12 months;Plaque Index (PlI)in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis.Timepoint: Baseline, 3,6,9 and 12 months;Gingival Index (GI) in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis.Timepoint: Baseline, 3,6,9 and 12 months;Probing Pocket Depth (PPD) in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis.Timepoint: Baseline, 3,6,9 and 12 months;Clinical Attachment Level (CAL) in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis.Timepoint: Baseline, 3,6,9 and 12 months;Gingival Recession (GR) in subjects at risk or not at risk of ASCVD in Stage II or Stage III Periodontitis.Timepoint: Baseline, 3,6,9 and 12 months | — |
Countries
India
Contacts
Public ContactDr Mangesh Phadnaik
Government Dental College and Hospital, Nagpur
Outcome results
None listed