Clinical Evaluation of Thermoresponsive and Mucoadhesive Chitosan In Situ Gel Containing Levofloxacin and Metronidazole in The Treatment of Periodontal Pockets – A Split-mouth, Clinical Study

Jump To References Section

Authors

  • Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi 221005 ,IN
  • Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi 221005 ,IN
  • Department of Pharmaceutics, Indian Institute of Technology, Banaras Hindu University, Varanasi 221005 ,IN
  • Department of Pharmaceutics, Indian Institute of Technology, Banaras Hindu University, Varanasi 221005 ,IN
  • Department of Pharmaceutics, Indian Institute of Technology, Banaras Hindu University, Varanasi 221005 ,IN
  • Department of Microbiology, Faculty of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi 221005 ,IN

Keywords:

Chitosan, In Situ Gel, Mucoadhesive, Periodontal Pocket, Thermoresponsive
Pharmaceutics

Abstract

Objectives: Recently, mucoadhesive formulations have become popular as drug delivery for periodontal pocket and oral mucosa. The objective of this study was to evaluate the clinical efficacy of thermoresponsive and mucoadhesive chitosan in situ gel in treatment of chronic periodontitis.
Methods: Vehicle and medicated in situ gel containing Levofloxacin and Metronidazole was applied in ten systemically healthy subjects (20–50 yrs) with chronic periodontitis adjunctive to scaling and root planing (SRP) in comparison to SRP alone. Clinical parameters were plaque index (PI), gingival index (GI), and bleeding on probing (BoP), which were recorded at baseline and 15th, 30th, 60th, and 90th days, as well as probing pocket depth (PPD), clinical attachment level (CAL), and gingival recession (GR), which were recorded at baseline and 30th, 60th, and 90th days.
Results: The results suggested that changes in clinical parameters were significant from baseline for all groups on the 90th day. On the 90th day, PI was 0.7 ± 0.48, 0.4 ± 0.51, and 0.3 ± 0.48; GI was 0.6 ± 0.051, 0.5 ± 0.52, and 0.3 ± 0.48; BoP was 0.5 ± 0.52, 0.3 ± 0.48, and 0.2 ± 0.42; PPD reduction was 2.5 ± 0.52 mm, 3.4 ± 0.69 mm, and 4.6 ± 0.51 mm; CAL gain was 1.2 ± 0.42 mm, 2.6 ± 0.84 mm, and 3.8 ± 0.42 mm; and GR was 1.1 ± 0.73 mm, 1.0 ± 0.00 mm, and 0.5 ± 0.52 mm for SRP, vehicle, and medicated in situ gel groups, respectively. Reduction in PPD and gain in CAL was also significant after comparison between the treatment groups.
Conclusion: Vehicle and medicated in situ gel showed better clinical outcomes as compared to SRP alone, which could be attributed to the presence of chitosan that is not only effective in treatment of periodontitis but also acts as a good carrier to deliver drug into periodontal pockets.

Published

2018-09-07

How to Cite

Bansal, M., Mittal, N., Yadav, S. K. R., Khan, G., Mishra, B., & Nath, G. (2018). Clinical Evaluation of Thermoresponsive and Mucoadhesive Chitosan In Situ Gel Containing Levofloxacin and Metronidazole in The Treatment of Periodontal Pockets – A Split-mouth, Clinical Study. Journal of Pierre Fauchard Academy (India Section), 30(1), 6–14. Retrieved from http://www.informaticsjournals.com/index.php/jpfa/article/view/22189

Issue

Section

Original Articles

 

References

Mealy BL. Influence of periodontal infections on systemic health. Periodontology 2000. 1999;21:197–209.

Carranza FA, Camargo PM. The periodontal pocket. In: Newman MG, Takei HH, Carranza FA, eds. In: Clinical Periodontology 9th ed. New Delhi; 2003:336–353.

Rams TE, Slots J. Antibiotics in periodontal therapy: an update. Compend Contin Educ Dent. 1992;13:1130.

Walker CB, Gordon JM, Socransky SS. Antibiotic susceptibility testing of subgingival plaque samples. J Clin Periodontol. 1983;10:422–432.

Jolkovsky DL, Ciancio SG. Chemotherapeutic agents in the treatment of periodontal diseases. In: Newman MG, Takei HH, Carranza FA, eds. In: Clinical Periodontology 9th ed. New Delhi; 2003:675–687.

Noyan U, Yilmaz S, Kuru B, Kadir T, Acar O, Buget E. A clinical and microbiological evaluation of systemic and local metronidazole delivery in adult periodontitis patients. J Clin Periodontol. 1997;24:158–165.

Slots J. Selection of antimicrobial agents in periodontal therapy. J Periodontal Res. 2002;37:389–398.

Lofmark S, Edlund C, Nord CE. Metronidazole is still the drug of choice for treatment of anaerobic infections. Clin Infect Dis. 2010;50(suppl 1):S16–S23.

Davis R, Bryson HM. Levofloxacin. A review of its antibacterial activity, pharmacokinetics and therapeutic efficacy. Drugs. 1994;47:677–700.

Ogrendik M. Levofloxacin treatment in patients with rheumatoid arthritis receiving methotrexate. South Med J. 2007;100:135–139.

Reisbeck k. Immunomodulating activity of quinolones: review. J Chemother. 2002;14:3–12.

Goodson JM. Pharmacokinetic principles controlling efficacy of oral therapy. J Dent Res. 1989;68:1625–1632.

Denkbas EB, Ottenbrite RM. Perspectives on: chitosan drug delivery systems based on their geometries. J Bioact Compat Polym. 2006;21:351–368.

Berger J, Reist M, Mayer JM, Felt O, Peppas NA, Gurny R. Structure and interactions in covalently and ionically crosslinked chitosan hydrogels for biomedical applications. Eur J Pharm Biopharm. 2004;57:19–34.

Khan G, Yadav SK, Patel RR, Nath G, Bansal M, Mishra B. Development and evaluation of biodegradable chitosan films of metronidazole and levofloxacin for the management of periodontitis. AAPS PharmSciTech. 2015 [Epub ahead of print].

Silness J, Loe H. Periodontal disease in pregnancy. II. Correlation between oral hygiene and periodontal condition. Acta Odontol Scand. 1964;22:121–135.

Loe H. the gingival index, the plaque index and the retention index system. J Periodontol. 1967;38(suppl):610–616.

Loe H, Silness J. Periodontal disease in pregnancy. I. Prevalence and severity. Acta Odontol Scand. 1963;21:533–551.

Carranza FA. Clinical diagnosis. In: Newman MG, Takei HH, Carranza FA, eds. In: Clinical Periodontology 9th ed. New Delhi; 2003:336–353.

Christopher Clark D, Chin Quee T, Bergeron MJ, Chan ECS, Lautar-Lemay C, De Gruchy KD. Reliability of attachment level measurements using the cementoenamel junction and a plastic stent. J Periodontol. 1987;58:115.

Bowen JA, Mellonig JT, Gray JL, Towle HT. Comparison of decalcified freeze-dried bone allograft and porous particulate hydroxyapetite in human periodontal osseous

defects. J Periodontol. 1989;60:647–654.

Schyeyer ET. A clinical comparison of a bovine derived xenograft used alone or in combination with enamel matrix derivative for the treatment of periodontal osseous defects in humans. J Periodontol. 2002;73:423.

Escobar-Chávez JJ, López-Cervantes M, Naí¯k A, Kalia YN, Quintanar-Guerrero D, Ganem-Quintanar A. Applications of thermo-reversible pluronic F-127 gels in pharmaceutical formulations. J Pharm Pharm Sci. 2006;9:339–358.

Ikinci G, Senel S, Akincibay H, et al. Effect of chitosan on a periodontal pathogen Porphyromonas gingivalis. Int J Pharm. 2002;235:121–127.

Akincibay H, Senel S, Ay ZY. Application of chitosan gel in the treatment of chronic periodontitis. J Biomed Mater Res Part B: Appl Biomater. 2007;80:290–296.

Graca MA, Watts TLP, Wilson RF, Palmer RM. A randomized controlled trial of a 2% minicycline gel as an adjunct to non surgical periodontal treatment, using a design with multiple matching criteria. J Clin Periodontol. 1997;24:249–253.

Ainamo J, Lie T, Ellingsen BH, et al. Clinical responses to subgingival application of a metronidazole 25% gel compared to the effect of subgingival scaling in adult periodontitis. J Clin Periodontol. 1992;19:723–729.

Needleman IG, Martin GP, Smales FC. Characterization of bioadhesives for periodontal and oral mucosal drug delivery. J Clin Periodontol. 1998;25:74–82.

Nair MK, Chien YW. Development of anticandidal delivery systems. II. Mucoadhesive devices for prolonged drug delivery in the oral cavity. Drug Dev Ind Pharm. 1996;22: 243–253.

Bouckaert S, Schautteet H, Lefebvre RA, Remon JP, Van clooster R. Comparison of salivary miconazole concentration after administration of a bioadhesive slow

release buccal tablet and an oral gel. Eur J Clin Pharmacol. 1992;43:137–140.

Kumari N, Pathak K. Dual controlled release, in situ gelling periodontal sol of metronidazole benzoate and serratiopeptidase: statistical optimization and mechanistic evaluation. Curr Drug Deliv. 2012;9:74–84.

Rams TE, Feik D, Slots J. Ciprofloxacin/metronidazole treatment of recurrent adult periodontitis. Abstract. J Dent Res. 1992;71:319.