Beneficial Effects of Subginigivally Delivered 1.2% Simvastatin Gel in the Treatment of Patients with Chronic Peridontits: A Randomized Clinical Trial
*Corresponding Author: Dr. Pooja Arora, Senior Lecturer, Dept. of Periodontology, Adesh Institute of Dental Sciences & Research, Bathinda, Punjab, India
Periodontitis is an inflammatory disease of supporting tissues of teeth, caused by group of specific microorganisms resulting in bone resorption creating bony defects, which may cause tooth loss. Various drugs of class Statins, for examples, simvastatin (SMV), lovastatin, and pravastatin modulate the bone formation. So, the present clinical trial is designed to investigate the effectiveness of SMV (1.2-mg) as a local drug delivery system as an adjunct to scaling and root planing (SRP) for the treatment of Chronic Periodontitis.
To evaluate the clinical efficacy of SMV (1.2 mg) as a local drug delivery as an adjunct to SRP in treatment of generalised chronic periodontitis and to evaluate efficacy of SMV in promoting bone regeneration.
Material and methods
A prospective, interventional and randomized controlled trial with split mouth design was planned. Thirty patients (14 males and 16 females) were screened. The patient would be evaluated for the clinical parameters which includes mSBI [modified sulcus bleeding index],. PD [probing depth],. CAL [clinical attachment level] at baseline, 3months and 6 months. After the indices were recorded at baseline. The sites were randomly assigned either to SMV group or to the placebo group. Thus, the two groups were formed: Group I, control group (SRP + placebo gel) = In which a placebo gel was placed after SRP. Group II, test group (SRP + SMV gel) = In which SMV gel was placed after SRP. Radiographic evaluation would be done at baseline and 6 months by using long cone paralleling technique. Follow up was done at 3 and 6 months respectively for measuring the clinical parameters and 6 months for radiographic parameters. After obtaining the complete data, the results were statistically analysed.
A total of thirty patients were participated in the study. Both groups showed improvement in periodontal parameters. There was significant reduction in m-SBI from baseline to 6 months was observed in both the groups. Reduction in PD and gain in CAL was also observed in both the groups from baseline to 6 months. But a noticeable reduction in PD and gain in CAL was observed in groups 2 between 3 and 6 months whereas it was insignificant in group 1 during this period. Radiographic measurements of osseous defect was compared, and it was found that mean radiographic bone fill was seen in both the groups from baseline to 6 months but it was more significant in group 2 than in comparison with group 1.
The 6 months clinical trial study was found to be statistically significant with greater reduction in PD, more CAL gain and greater intra bony defect fill at sites treated with SRP and Simvastatin than the SRP and placebo alone. So local application of SMV (1.2mg) is beneficial in treatment of chronic periodontitis along with SRP.
Chronic Periodontitis, Simvastatin (SMV), mSBI [modified sulcus bleeding index], PD [probing depth], CAL [clinical attachment level], SRP(Scaling root planing).