CC BY-NC-ND 4.0 · Eur J Dent 2019; 13(01): 029-035
DOI: 10.1055/s-0039-1688522
Original Article
Dental Investigation Society

Efficacy of Locally Administered 1.2% Rosuvastatin Gel in Patients with Periodontitis: A Randomized Placebo Controlled Clinical Trial

Debopriya Chatterjee
1   Department of Periodontics, College of Dental Sciences, Rajasthan University of Health Sciences, Jaipur, Rajasthan, India
,
Anjali Kapoor
1   Department of Periodontics, College of Dental Sciences, Rajasthan University of Health Sciences, Jaipur, Rajasthan, India
,
Sharmistha Vijay
1   Department of Periodontics, College of Dental Sciences, Rajasthan University of Health Sciences, Jaipur, Rajasthan, India
,
Geetika Sobti
2   Department of Oral Medicine, Radiology and Diagnosis, College of Dental Sciences, Rajasthan University of Health Sciences, Jaipur, Rajasthan, India
,
Dheeraj Kara
3   Department of Public Health, YMT Dental College, Navi Mumbai, Maharashtra, India
,
Jaishree Thanvi
2   Department of Oral Medicine, Radiology and Diagnosis, College of Dental Sciences, Rajasthan University of Health Sciences, Jaipur, Rajasthan, India
› Author Affiliations
Further Information

Publication History

Publication Date:
06 June 2019 (online)

Abstract

Objective Periodontitis initiation and progression are a result of host immune inflammatory response to oral pathogens. Several pharmacological agents are being delivered locally, to improve periodontal health. Hence, the present randomized placebo controlled clinical trial is designed to check the clinical and antimicrobial efficacy of locally delivered 1.2% rosuvastatin (RSV) in intrabony defects (IBD) in periodontitis patients.

Materials and Methods One-hundred patients were randomly allotted into two treatment groups: group A received 1. 2% RSV gel, scaling and root debridement and group B received placebo gel, scaling and root debridement. Clinical parameters, including modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL), and plaque index (PI), were recorded at baseline before phase 1 and after 6 months. Radiographic assessment of IBD was done by cone beam computed tomography at baseline and after 6 months. Anaerobic colony count was done at baseline and after 180 days.

Results On intragroup comparison, there is a significant improvement in periodontal parameters in both the groups. On intergroup comparison, there is significant gain in CAL in group A than group B (p = 0.04). There is significant decrease in PD in group A, compared to group B. There is significant bone fill in group A (p = 0.034), compared to group B. With respect to mSBI, PI, and anaerobic colony count, there is no significant difference between the two groups after 6 months. No adverse effect was noticed in any subjects.

Conclusion The author concludes that 1.2% RSV gel when delivered locally into IBD improved periodontal clinical parameters such as PD and CAL and showed significant bone fill.

 
  • References

  • 1 Slots J. Periodontology: past, present, perspectives. Periodontol 2000 2013; 62 (01) 7-19
  • 2 Shimizu H, Nakagami H, Morita S. et al. New treatment of periodontal diseases by using NF-kappaB decoy oligodeoxynucleotides via prevention of bone resorption and promotion of wound healing. Antioxid Redox Signal 2009; 11 (09) 2065-2075
  • 3 Haffajee AD, Socransky SS. Microbial etiological agents of destructive periodontal diseases. Periodontol 2000 1994; 5: 78-111
  • 4 Seymour GJ. Importance of the host response in the periodontium. J Clin Periodontol 1991; 18 (06) 421-426
  • 5 Pihlstrom BL. Periodontal risk assessment, diagnosis and treatment planning. Periodontol 2000; 2001 (25) 37-58
  • 6 Vandekerckhove BN, Quirynen M, van Steenberghe D. The use of locally delivered minocycline in the treatment of chronic periodontitis. A review of the literature. J Clin Periodontol 1998; 25 (11) Pt 2 964-968 discussion 978–979
  • 7 Pandit N, Dahiya R, Gupta R, Bali D, Kathuria A. Comparative evaluation of locally delivered minocycline and metronidazole in the treatment of periodontitis. Contemp Clin Dent 2013; 4 (01) 48-53
  • 8 Da Rocha HA, Silva CF, Santiago FL, Martins LG, Dias PC, De Magalhães D. Local drug delivery systems in the treatment of periodontitis: a literature review. J Int Acad Periodontol 2015; 17 (03) 82-90
  • 9 Evans M, Roberts A, Davies S, Rees A. Medical lipid-regulating therapy: current evidence, ongoing trials and future developments. Drugs 2004; 64 (11) 1181-1196
  • 10 Garrett IR, Mundy GR. The role of statins as potential targets for bone formation. Arthritis Res 2002; 4 (04) 237-240
  • 11 Resch U, Tatzber F, Budinsky A, Sinzinger H. Reduction of oxidative stress and modulation of autoantibodies against modified low-density lipoprotein after rosuvastatin therapy. Br J Clin Pharmacol 2006; 61 (03) 262-274
  • 12 Willerson JT, Ridker PM. Inflammation as a cardiovascular risk factor. Circulation 2004; 109 (21) (Suppl. 01) II2-II10
  • 13 Jerwood S, Cohen J. Unexpected antimicrobial effect of statins. J Antimicrob Chemother 2008; 61 (02) 362-364
  • 14 Monjo M, Rubert M, Ellingsen JE, Lyngstadaas SP. Rosuvastatin promotes osteoblast differentiation and regulates SLCO1A1 transporter gene expression in MC3T3-E1 cells. Cell Physiol Biochem 2010; 26 (04) (05) 647-656
  • 15 Maeda T, Matsunuma A, Kurahashi I, Yanagawa T, Yoshida H, Horiuchi N. Induction of osteoblast differentiation indices by statins in MC3T3-E1 cells. J Cell Biochem 2004; 92 (03) 458-471
  • 16 Jordan E, Hsu YT, Bashutski J. Do statin medications improve periodontal health and/or outcomes?. A systematic review. Clinic Adv Periodontics 2014; 4 (03) 194-202
  • 17 Muniz FWMG, Taminski K, Cavagni J, Celeste RK, Weidlich P, Rösing CK. The effect of statins on periodontal treatment-a systematic review with meta-analyses and meta-regression. Clin Oral Investig 2018; 22 (02) 671-687
  • 18 Deas DE, Moritz AJ, Sagun Jr RS, Gruwell SF, Powell CA. Scaling and root planing vs. conservative surgery in the treatment of chronic periodontitis. Periodontol 2000 2016; 71 (01) 128-139
  • 19 Silness J, Loe H. Periodontal disease in pregnancy. II. Correlation between oral hygiene and periodontal condtion. Acta Odontol Scand 1964; 22: 121-135
  • 20 El-Makaky YM. Clinical and radiographical evaluation of osseointegration around immediate endosseous implant using fresh-frozen bone allograft. J Am Sci 2013; 9: 90-97
  • 21 Final report on the safety assessment of hydroxyethyl cellulose, hydroxypropyl cellulose, methylcellulose, hydroxypropyl methylcellulose and cellulose gum. Int J Toxicol 1986; 5: 1-59
  • 22 Amano A. Host-parasite interactions in periodontitis: microbial pathogenicity and innate immunity. Periodontol 2000 2010; 54 (01) 9-14
  • 23 Tandon V, Bano G, Khajuria V, Parihar A, Gupta S. Pleiotropic effects of statins. Indian J Pharmacol 2005; 37 (02) 77-85
  • 24 Tobert JA. New developments in lipid-lowering therapy: the role of inhibitors of hydroxymethylglutaryl-coenzyme A reductase. Circulation 1987; 76 (03) 534-538
  • 25 Ghosh-Choudhury N, Mandal CC, Choudhury GG. Statin-induced Ras activation integrates the phosphatidylinositol 3-kinase signal to Akt and MAPK for bone morphogenetic protein-2 expression in osteoblast differentiation. J Biol Chem 2007; 282 (07) 4983-4993
  • 26 Maeda T, Matsunuma A, Kawane T, Horiuchi N. Simvastatin promotes osteoblast differentiation and mineralization in MC3T3-E1 cells. Biochem Biophys Res Commun 2001; 280 (03) 874-877
  • 27 Landmesser U, Bahlmann F, Mueller M. et al. Simvastatin versus ezetimibe: pleiotropic and lipid-lowering effects on endothelial function in humans. Circulation 2005; 111 (18) 2356-2363
  • 28 Pradeep AR, Karvekar S, Nagpal K, Patnaik K, Guruprasad CN, Kumaraswamy KM. Efficacy of locally delivered 1.2% rosuvastatin gel to non-surgical treatment of patients with chronic periodontitis: a randomized, placebo-controlled clinical trial. J Periodontol 2015; 86 (06) 738-745
  • 29 Kumar M, Shanavas M, Sidappa A, Kiran M. Cone beam computed tomography — know its secrets. J Int Oral Health 2015; 7 (02) 64-68
  • 30 Joss A, Adler R, Lang NP. Bleeding on probing. A parameter for monitoring periodontal conditions in clinical practice. J Clin Periodontol 1994; 21 (06) 402-408
  • 31 Lang NP, Joss A, Orsanic T, Gusberti FA, Siegrist BE. Bleeding on probing. A predictor for the progression of periodontal disease?. J Clin Periodontol 1986; 13 (06) 590-596
  • 32 Alagić-Džambić L, Omerović S, Džambić M. Antimicrobial activity of rosuvastatin. Int J Pharm Tech 2015; 6 (04) 7587-7592
  • 33 Tekce M, Ince G, Gursoy H. et al. Clinical and microbiological effects of probiotic lozenges in the treatment of chronic periodontitis: a 1-year follow-up study. J Clin Periodontol 2015; 42 (04) 363-372
  • 34 Fajardo ME, Rocha ML, Sánchez-Marin FJ, Espinosa-Chávez EJ. Effect of atorvastatin on chronic periodontitis: a randomized pilot study. J Clin Periodontol 2010; 37 (11) 1016-1022
  • 35 Pradeep AR, Garg V, Kanoriya D, Singhal S. 1.2% rosuvastatin versus 1.2% atorvastatin gel local drug delivery and redelivery in treatment of intrabony defects in chronic periodontitis: a randomized placebo-controlled clinical trial. J Periodontol 2016; 87 (07) 756-762
  • 36 Messora MR, Apolinário Vieira GH, Vanderlei JMTMM. et al. Rosuvastatin promotes benefits on induced periodontitis in hypertensive rats. J Periodontal Res 2017; 52 (04) 734-744
  • 37 Monjo M, Rubert M, Wohlfahrt JC, Rønold HJ, Ellingsen JE, Lyngstadaas SP. In vivo performance of absorbable collagen sponges with rosuvastatin in critical-size cortical bone defects. Acta Biomater 2010; 6 (04) 1405-1412
  • 38 Pradeep AR, Thorat MS. Clinical effect of subgingivally delivered simvastatin in the treatment of patients with chronic periodontitis: a randomized clinical trial. J Periodontol 2010; 81 (02) 214-222