|Year : 2022 | Volume
| Issue : 2 | Page : 180-183
|Comparative effect of 1.2% atorvastatin gel and 1.2% rosuvastatin as a local drug delivery in treatment of intra-bony defects in chronic periodontitis
Ashish Soni1, Swati Raj2, Laxmikant Kashyap1, Amit Upadhyay1, Vikas Chandra Agrahari3, Anil Sharma4
1 Department of Periodontics, New Horizon Dental College, Bilaspur, Chattishgarh, India
2 Department of Periodontics, Triveni Dental College, Bilaspur, Chattishgarh, India
3 Senior Lecturer, Department of Prosthodontics, New Horizon Dental College, Bilaspur, Chattishgarh, India
4 Department of Periodontics, Maitri College of Dentistry and Research Center, Bilaspur, Chattishgarh, India
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|Date of Submission||09-Jan-2021|
|Date of Decision||20-Sep-2021|
|Date of Acceptance||23-Oct-2021|
|Date of Web Publication||13-Oct-2022|
| Abstract|| |
Background: The present study was aimed to evaluate the efficacy of 1.2% Atorvastatin (ATV) with 1.2% Rosuvastatin (RSV) as local drug delivery for treatment of Chronic Periodontitis (CP). Materials and Methods: Forty patients were equally divided into two groups. Group A underwent scaling and root debridement and 1.2% ATV gel (1.2 mg/0.1 mL) was placed, whereas group B received scaling and root debridement and RSV (1.2 mg/0.1 ml) was placed. Results: The results showed that both the groups had improvement in all the recorded parameters, and the results obtained were statistically significant. When comparison was made between the groups, no significant difference was obtained between atorvastatin and rosuvastatin at baseline in all recorded parameters. However, after 6 months significant improvement was recorded in CAL (Clinical attachment level) and PD (Probing depth). The plaque index (PI) and gingival index (GI) score however showed improvement, but it did not attain the level of significance. Conclusion: The present study showed improvement in clinical parameters with the use of ATV and RSV gel when used in combination with scaling and root planing (SRP) in CP patients. Patients with RSV gel showed up significantly better than the ones in which ATV gel was placed.
Keywords: Atorvastatin gel, chronic periodontitis, rosuvastatin
|How to cite this article:|
Soni A, Raj S, Kashyap L, Upadhyay A, Agrahari VC, Sharma A. Comparative effect of 1.2% atorvastatin gel and 1.2% rosuvastatin as a local drug delivery in treatment of intra-bony defects in chronic periodontitis. Indian J Dent Res 2022;33:180-3
|How to cite this URL:|
Soni A, Raj S, Kashyap L, Upadhyay A, Agrahari VC, Sharma A. Comparative effect of 1.2% atorvastatin gel and 1.2% rosuvastatin as a local drug delivery in treatment of intra-bony defects in chronic periodontitis. Indian J Dent Res [serial online] 2022 [cited 2022 Nov 29];33:180-3. Available from: https://www.ijdr.in/text.asp?2022/33/2/180/358444
| Introduction|| |
Periodontitis is a multifactorial disease, which is a result of the host immune inflammatory response to microbial complexes. The endotoxins produced by these pathogens activate the defence cells, thus leading to the production of various cytokines like IL-1 beta, TNF-alpha, IL-6 and MMPs. These chemical mediators lead to the increased osteoclastic activity, thus affecting the supporting tissue of the periodontium—cementum, periodontal ligament and alveolar bone.,,
The rationale of periodontal therapy is to prevent the progression of the disease and regenerate the lost tissue structures. Various treatment modalities such as scaling and root planing (SRP) in conjunction with local or systemic anti-inflammatory and antimicrobial agents can be used for tissue regeneration. Other treatment options that are known to decrease the intra-bony defects (IBDs) include using various regenerative materials such as bone grafts, growth factors, bisphosphonates, statins, platelet analogues like platelet rich fibrin (PRF) and metformin.,
Statins are competitive inhibitors that belong to a group of HMG CoA (3-hydroxyl-3-methyl glutaryl coenzyme A) and are most commonly employed to prevent the risk of major coronary events by reducing the levels of low-density lipoprotein cholesterol. Other than that, it also has antioxidant, immunomodulatory, endothelium stabilisation and antithrombotic actions. Statins have also been found to increase the expression of Bone Morphogenetic Protein-2 mRNA in osteogenic cells, thus triggering the bone formation.,
These bone stimulating and anti- inflammatory actions of statins can be used to treat the periodontal defects, especially hard tissue regeneration. The present study was aimed to evaluate the efficacy of 1.2% ATV with that of 1.2% RSV as local drug delivery in the treatment of Chronic Periodontitis (CP).
| Materials and Method|| |
The study was conducted in the Department of Periodontics, and was approved by Institutional Ethical Review Board (NHDC&RI/2019/2019/ECC-315). Forty patients based on inclusion and exclusion criteria formed the part of the study.
- Healthy patients with no systemic disease
- Patients with probing depth (PD) ≥4 mm
- Subjects with ≥20 teeth with no history of antibiotic and periodontal therapy six months prior to the initiation of the study.
- Patients on statin therapy
- Immunocompromised patients
- Patients using any form of tobacco
- Pregnant and lactating females.
Patients were randomly and equally divided into two groups. Group A underwent scaling and root debridement and 1.2% RSV gel (1.2 mg/0.1 mL) was placed, whereas group B received scaling and root debridement and ATV gel (1.2 mg/0.1 mL) was placed.
LDD gel formulation
For preparation of RSV and ATV gels, a biocompatible solvent was mixed with pre-measured quantity of methylcellulose, which was then heated to 50–60°C in a vial. Mechanical shaker was used for constantly agitating the solution so that clear solution could be obtained. After the solution became clear, pre-weighed quantity of RSV or ATV was added.
Collection of data
Clinical parameters like Plaque Index (PI), Gingival index (GI), Clinical attachment level (CAL) and pocket PD were measured at different time intervals (at baseline, 1 month of gel placement and after 6 months). 21 gauge needle with blunt cannula was used for placing the gel in the oral cavity. About 0.25 ml of gel was placed into the periodontal pocket followed by Coe-pak dressing. Radiographic assessment was done at baseline and after 6 months.
| Results|| |
[Table 1] showed that there were 11 males and nine females in group 1 and eight males and 12 females in group 2.
[Table 2] showed mean and standard deviation of the clinical parameters at baseline and at sixth month for patients treated with RSV (group A). The mean PI at baseline and after 6 months was 1.70 and 1.18, respectively, GI was 1.63 and 1.13, respectively, clinical attachment loss was 6.1 and 5.1, respectively and PD was 5.3 and 4.15, respectively. There was significant difference between baseline and after 6 months (P < 0.05).
|Table 2: Clinical parameters at baseline and at sixth month for patients treated with RSV (group A)|
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[Table 3] showed mean and standard deviation of the clinical parameters at baseline and at sixth month for patients treated with ATV (group B). The mean PI at baseline and after 6 months was 1.54 and 1.27, respectively, GI was 1.59 and 1.2, respectively, clinical attachment loss was 5.9 and 5.3, respectively and PD was 5.1 and 4.6, respectively. There was significant difference between baseline and after 6 months (P < 0.05).
|Table 3: Clinical parameters at baseline and at sixth month for patients treated with ATV (group B)|
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[Table 4] showed intergroup comparison between different parameters at different time intervals. The results showed that both the groups showed improvement in all the recorded parameters, and the results obtained were statistically significant (P < 0.05) [Table 1] and [Table 2]. When comparison was made between the groups no significant difference was obtained between ATV and rosuvastatin at baseline in all recorded parameters. However, after 6 months significant improvement was recorded in CAL and PD. The PI and GI score however showed improvement, but it did not attain the level of significance.
|Table 4: Intergroup comparison among different parameters at different time intervals|
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| Discussion|| |
Periodontal therapy aims to restore the periodontal tissue that has been lost due to periodontal diseases. Periodontitis is a condition in which there is a collection of inflammatory cells, which produce cytokines that lead to activation of osteoclasts, thereby resulting in resorption of alveolar bone and attachment loss.,, Statins have been suggested to have osteoblastic properties and have shown to stimulate the bone formation, thus being useful for patients with periodontal infection., The present study was aimed to evaluate the efficacy of 1.2% ATV with that of 1.2% RSV as local drug delivery in the treatment of CP.
The present study showed that significant improvement was seen on PI, GI, PD and CAL after 6 months of treatment in both the groups. The results of the present study are in accordance with the study conducted by Sinjab et al. who in their meta-analysis found that use of statin as a locally delivered drug in combination with mechanical SRP was useful in periodontal regeneration. There was improvement in the inflammatory condition seen. The PD got reduced and there was gain in clinical attachment loss. In a study by Chatterjee et al., it was showed that 1.2% RSV gel when delivered locally into IBD improved periodontal clinical parameters such as PD and CAL and showed significant bone fill.
On comparing RSV with ATV, it was seen that there was no significant difference observed in the PI and GI between both groups; however, the PD and CALs showed significant difference after 6 months.
The mean reduction in the value of PD in group A in the present study after 6 months was 0.45 ± 0.02, whereas for group B it was 0.5 ± 0.1. The results were in accordance to the study conducted by Pradeep et al. who also showed that RSV group showed significant improvement in all clinical parameters when compared to ATV group in treatment of mandibular class II furcation defects as an adjunct to SRP. Similar results were obtained by Garg et al. who showed that RSV is a better choice of statin and showed significant improvement then ATV. Similarly, Singh et al. found the antimicrobial effects of ATV giving significant reduction in PI, GI, PPD and gain in CAL along with significant decrease in the microbial load.
Kanoriya et al. assessed the effectiveness of 1.2% RSV gel in addition to SRP in smokers with CP in 60 patients, which were divided into two treatment groups, that is SRP with placebo gel (Group 1) and SRP with 1.2% RSV gel (Group 2). Clinical parameters were determined at regular intervals (baseline, 3, 6 and 9 months). The authors found significant greater mean PD reduction and greater mean gain in CAL in the RSV group at different time periods as compared to placebo. A greater mean defect depth reduction was obtained in the RSV group (23.91 ± 1.03, 29.24 ± 0.834) after 6 and 9 months, respectively. Similar results were also found among different studies conducted by Pradeep et al. and Ramesh et al.
Cao et al. assessed IBD, PD and CAL. It was observed that there was greater filling of IBD, reduction in PD and gain in CAL for SRP treated in combination with statins when compared to SRP alone for treating CP without systemic diseases. In CP patients with type 2 diabetic (T2DM) or in smokers, additional benefits were observed from locally delivered statins.
Kumari et al. determined utility of 1.2% ATV gel in the treatment of IBDs in 75 CP patients with T2DM who were categorized into two groups: 1) SRP plus 1.2% ATV and 2) SRP plus placebo. Results showed greater mean PD reduction and mean RAL gain in the ATV group than the placebo group at 3, 6 and 9 months. Furthermore, ATV group sites presented with a significantly greater percentage of radiographic defect depth reduction at 6 and 9 months. Similar results were also found among different studies conducted by Singh et al. and Cao et al.
| Conclusions|| |
The present study shows improvement in clinical parameters with the use of ATV and RSV gel when used in combination with SRP in CP patients. Patients with RSV gel showed significantly better than the ones in which ATV gel was placed. There is scope for these two gels to be used for future studies, which can involve larger population to show better results. Other studies evaluating the use of host modulators (modulators of inflammation, prebiotics, probiotics, antioxidant micronutrients) administered either topically or systemically in combination with non-surgical periodontal therapy may be used to evaluate their effect other than statins.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Holt SC, Ebersole JL. Porphyromonasgingivalis, treponemadenticola, and tannerella forsythia: The 'redcomplex', A prototype polybacterial pathogenic consortium in periodontitis. Periodontol 2000 2005;38:72-122.
Carranza FA, Takei HH. Clinical diagnosis. In: Newman MC, Klokkevold PR, editors. Carranza's Clinical Periodontology. 10th
ed. Missouri: Saunders, Elsevier; 2007. p. 540-60.
Grover HS, Luthra S, Maroo S, Maroo N. The pleotropic role of statins: Could it be the imminent host modulation agent in periodontics? Dent Res J (Isfahan) 2013;10:143-8.
Bartold PM, Cantley MD, Haynes DR. Mechanisms and control of pathologic bone loss in periodontitis. Periodontol 2000 2010;53:55-69.
Elavarasu S, Suthanthiran TK, Naveen D. Statins: A new era in local drug delivery. J Pharm Bioallied Sci 2012;4(Suppl 2):S248-51.
Stalker TJ, Lefer AM, Scalia R. A new HMG-CoA reductase inhibitor, rosuvastatin, exerts anti-inflammatory effects on the microvascular endothelium: The role of mevalonic acid. Br J Pharmacol 2001;133:406-12.
Rao NS, Pradeep AR, Bajaj P, Kumari M, Naik SB. Simvastatin local drug delivery in smokers with chronic periodontitis: A randomized controlled clinical trial. Aust Dent J 2013;58:156-62.
Ruan F, Zheng Q, Wang J. Mechanisms of bone anabolism regulated by statins. Biosci Rep 2012;32:511-9.
Sinjab K, Zimmo N, Lin GH, Chung MP, Shaikh L, Wang HL. The effect of locally delivered statins on treating periodontal intrabony defects: A systematic review and meta-analysis. J Periodontol 2017;88:357-67.
Chatterjee D, Kapoor A, Vijay S, Sobti G, Kara D, Thanvi J. Efficacy of locally administered 1.2% rosuvastatin gel in patients with periodontitis: A randomized placebo controlled clinical trial. Eur J Dent 2019;13:29-35.
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;87:756-62.
Garg S, Pradeep AR. 1.2% Rosuvastatin and 1.2% atorvastatin gel local drug delivery and redelivery in the treatment of class II furcation defects: A randomized controlled clinical trial. J Periodontol 2017;88:259-65.
Singh R, Singh GB, Gupta S, Agrawal A. Effects of statins as local drug delivery agents in treating chronic periodontitis and their antimicrobial effects using polymerase chain reaction. J Global Oral Health 2020;3:82-8.
Kanoriya D, Bajaj N, Pradeep AR. 1.2% rosuvastatin gel as a local drug delivery agent in smokers with chronic periodontitis – A randomized controlled clinical trial. J Adv Clin Res Insights 2019;6:110-5.
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;86:738-45.
Ramesh A, Prakash AP, Thomas B. Local drug delivery in periodontal diseases. A review. NitteUniv J Health Sci 2016;6:74-9.
Cao R, Li Q, Chen Y, Yao M, Wu Q, Zhou H. Efficacy of locally-delivered statins adjunct to non-surgical periodontal therapy for chronic periodontitis: A Bayesian network analysis. BMC Oral Health 2019;19:105.
Kumari M, Martande SS, Pradeep AR, Naik SB. Efficacy of subgingivally delivered 1.2% atorvastatin in the treatment of chronic periodontitis in patients with type 2 diabetes mellitus: A randomized controlled clinical trial. J Periodontol 2016;87:1278-85.
Singh J, Singh R, Gambhir RS, Shewale A, Mahajan R. Local drug delivery system in treatement of periodontitis: A review. J Periodontal Med Clin Prac 2016;3:153-60.
Dr. Ashish Soni
Department of Periodontics, New Horizon Dental College, Bilaspur - 495 001, Chattishgarh
Source of Support: None, Conflict of Interest: None
[Table 1], [Table 2], [Table 3], [Table 4]
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