Chronic Periodontitis Wth Diabetes Mellitus
Conditions
Brief summary
Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM).
Detailed description
Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM). 120 subjects with intrabony defects were divided into three groups;group 1- SRP plus 1.2% ATV ; group 2- SRP PLUS 1.2% SMV; and group 3- SRP plus placebo gel. Clinical and radiographic measurements were taken at baseline, at 6 months and respective gels were redelivered subgingivally in respective groups . Measurements were repeated again at 3 months i.e. 9 months from baseline.
Interventions
DRUGATORVASTATIN
Scaling and Root Planing (SRP) followed by placement of atorvastatin gel
DRUGSIMVASTATIN
Scaling and Root Planing (SRP) followed by placement of simvastatin gel
DRUGPLACEBO
Scaling and Root Planing (SRP) followed by placement of placebo gel
Sponsors
Government Dental College and Research Institute, Bangalore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* well controlled type 2 diabetes mellitus patients classified based on criteria given by American diabetes association with CP with PD≥5mm and CAL ≥3mm and presence of IBD ≥ 3 mm (distance between alveolar crest and base of the defect on an intraoral periapical radiograph \[IOPAR\] after phase I therapy
Exclusion criteria
* 1)patients with known allergy to statins; 2) Patients with systemic conditions / medications known to affect the periodontal status; 3) aggressive and refractory periodontitis 4) Hematological disorders 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.8). patients with poor plaque control. 9). non vital teeth, carious teeth warranting restorations, third molars and mobility of at least grade II were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in defect depth | 6 and 9 months | assessed in percentage |
Secondary
| Measure | Time frame |
|---|---|
| change in probing depth (PD) | baseline, 6 and 9 months |
| change in Clinical Attachment Level (CAL) | baseline, 6 and 9 months |
| CHANGE IN Plaque Index (PI) | baseline, 6 and 9 months |
| change in modified Sulcus Bleding Index (mSBI) | baseline, 6 and 9 months |
Countries
India
Outcome results
None listed