Chronic Periodontitis
Conditions
Keywords
Chronic periodontitis, Local drug delivery,
Brief summary
Background: Statins are the recently evolved agents that aid in periodontal regeneration and ultimately attaining periodontal health. Atorvastatin (ATV) and Simvastatin (SMV) are specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. The present study was designed to evaluate and compare the effectiveness of 1.2% ATV, and 1.2% SMV as an adjunct to scaling and root planing (SRP) in the treatment subjects with chronic periodontitis. Methods: Ninety six subjects were categorized into three treatment groups: SRP plus 1.2% ATV, SRP plus 1.2% SMV and SRP plus placebo. Clinical parameters; full mouth plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and relative attachment level (RAL) were recorded at baseline before SRP and at 3, 6 and 9 months. Percentage radiographic defect depth reduction was evaluated using computer-aided software at baseline, 6 months and 9 months.
Interventions
DRUG1.2% Atorvastatin local drug delivery
DRUG1.2% simvastatin local drug delivery
DRUGPlacebo local drug delivery
Sponsors
Government Dental College and Research Institute, Bangalore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Moderate to severe CP subjects with PD ≥ 5 mm or clinical attachment level (CAL) ≥ 4 mm and vertical bone loss ≥3 mm on intraoral periapical radiographs and no history of antibiotic or periodontal therapy in the preceding 6 months
Exclusion criteria
* Individuals with systemic diseases known to alter the course of periodontal disease and treatment outcome, known or suspected allergy to the SMV/ATV/statin group, those on systemic SMV/ATV/statin therapy, individuals with aggressive periodontitis, use of tobacco in any form, alcoholics, individuals with diabetes, immunocompromised individuals, and pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Radiographic intra-bony defect depth. | 9 months from baseline | The primary outcome of the study was change in radiographic intra-bony defect depth from baseline to 9 months in all the groups. Intra-bony defect depth was measured on the radiograph by measuring the vertical distance from the crest of the alveolar bone to the base of the defect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing depth. | 9 months from baseline | Probing depth was measured from gingival margin to the base of pocket with a University of North Carolina no. 15 color-coded periodontal probe. change in probing depth was measured from baseline to 9 months. |
| Change in Relative attachment level | 9 months from baseline | Relative attachment level was measured from a fixed point on the acrylic stent to the to the base of pocket. . A custom-made acrylic stent and a University of North Carolina no. 15 color-coded periodontal probe were used to standardize the measurement. Change was measured from baseline to 9 months. |
| Change in mSBI (gingival index) | 9 months from baseline | modified sulcus bleeding index was measured at baseline and 9 months and the change in the values was taken as secondary outcome measure. |
| Change in plaque index | 9 months from baseline | Sillness and loe plaque index was measured at baseline an 9 months and change in the values was taken as secondary outcome variable. |
Outcome results
None listed