Clinical Evaluation of a Mouthwash Containing Malva Sylvestris Extract.
Summary
Background: For centuries, plants (and / or their products) were the only resource available for the prevention and treatment of many diseases. However, its indiscriminate use without phytochemical, pharmacological and toxicological knowledge is a concern for health. The Malva sylvestris (family Malvaceae and popularly known as Malva) is mentioned in the literature as an ethnopharmacological medicine with anti-inflammatory, antimicrobial, wound healing and other properties. For this reason, M. sylvestris presents empirical indications in dentistry, mainly in the treatment of periodontal diseases (gingivitis and periodontitis), which are highly prevalent worldwide. However, scientific evidence is scarce in information that supports the biological properties and clinical benefits attributed to it. Objective: The objective of this study was to evaluate the effect of a mouthwash based on Malva sylvestris in the control of gingival inflammation and dental biofilm. Methods: A randomized, three-group, triple-masked clinical trial was designed. Patients from the Center of Dental Clinics of the Austral University of Chile participated with a diagnosis of gingivitis and chronic periodontitis. They were distributed randomly in three study groups: 1. Chlorhexidine mouthwash 0.12%; 2. Mouthwash with extract of M. sylvestris and 3. Mouthwash control group. The indications and dosage were identical for all groups: rinse with 10 ml, for 1 minute, every 12 hours for 7 days. The gingival index and plaque control record were recorded at the beginning and end of the follow-up period (7 days). The results obtained between the groups were compared through normality test and group analysis (ANOVA/Mann-Whitney/Dunnet p \<0.05). Results: The pharmacological potential of M. sylvestris was determined in the reduction of the plaque control record and gingival index.
Timeline
- Start
- 2017-10-20
- Primary completion
- 2018-12-17
- Completion
- 2019-01-14
Publications
- Background Pihlstrom BL, Michalowicz BS, Johnson NW. Periodontal diseases. Lancet. 2005 Nov 19;366(9499):1809-20. doi: 10.1016/S0140-6736(05)67728-8.
- Background Hooks KB, O'Malley MA. Dysbiosis and Its Discontents. mBio. 2017 Oct 10;8(5):e01492-17. doi: 10.1128/mBio.01492-17.
- Background Gao L, Xu T, Huang G, Jiang S, Gu Y, Chen F. Oral microbiomes: more and more importance in oral cavity and whole body. Protein Cell. 2018 May;9(5):488-500. doi: 10.1007/s13238-018-0548-1. Epub 2018 May 7.
- Background Murakami S, Mealey BL, Mariotti A, Chapple ILC. Dental plaque-induced gingival conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S17-S27. doi: 10.1111/jcpe.12937.
- Background Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945.
- Background Rafiei M, Kiani F, Sayehmiri F, Sayehmiri K, Sheikhi A, Zamanian Azodi M. Study of Porphyromonas gingivalis in periodontal diseases: A systematic review and meta-analysis. Med J Islam Repub Iran. 2017 Sep 12;31:62. doi: 10.18869/mjiri.31.62. eCollection 2017.
- Background Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.
- Background Topcuoglu N, Kulekci G. 16S rRNA based microarray analysis of ten periodontal bacteria in patients with different forms of periodontitis. Anaerobe. 2015 Oct;35(Pt A):35-40. doi: 10.1016/j.anaerobe.2015.01.011. Epub 2015 Jan 29.
- Background Teles RP, Teles FR. Antimicrobial agents used in the control of periodontal biofilms: effective adjuncts to mechanical plaque control? Braz Oral Res. 2009;23 Suppl 1:39-48. doi: 10.1590/s1806-83242009000500007.
- Background Larsen T, Fiehn NE. Dental biofilm infections - an update. APMIS. 2017 Apr;125(4):376-384. doi: 10.1111/apm.12688.
- Background Loe H, Schiott CR, Karring G, Karring T. Two years oral use of chlorhexidine in man. I. General design and clinical effects. J Periodontal Res. 1976 Jun;11(3):135-44. doi: 10.1111/j.1600-0765.1976.tb00061.x. No abstract available.
- Background Gunsolley JC. Clinical efficacy of antimicrobial mouthrinses. J Dent. 2010 Jun;38 Suppl 1:S6-10. doi: 10.1016/S0300-5712(10)70004-X.
- Background Collins JR, Olsen J, Cuesta A, Silva-Vetri M, Hernandez M, Romanos G, Rajendra Santosh AB, Palma P. In vitro microbiological analysis on antibacterial, anti-inflammatory, and inhibitory action on matrix metalloproteinases-8 of commercially available chlorhexidine digluconate mouth rinses. Indian J Dent Res. 2018 Nov-Dec;29(6):799-807. doi: 10.4103/ijdr.IJDR_406_17.
- Background James P, Worthington HV, Parnell C, Harding M, Lamont T, Cheung A, Whelton H, Riley P. Chlorhexidine mouthrinse as an adjunctive treatment for gingival health. Cochrane Database Syst Rev. 2017 Mar 31;3(3):CD008676. doi: 10.1002/14651858.CD008676.pub2.
- Background Gurgan CA, Zaim E, Bakirsoy I, Soykan E. Short-term side effects of 0.2% alcohol-free chlorhexidine mouthrinse used as an adjunct to non-surgical periodontal treatment: a double-blind clinical study. J Periodontol. 2006 Mar;77(3):370-84. doi: 10.1902/jop.2006.050141.
- Background Van Strydonck DA, Slot DE, Van der Velden U, Van der Weijden F. Effect of a chlorhexidine mouthrinse on plaque, gingival inflammation and staining in gingivitis patients: a systematic review. J Clin Periodontol. 2012 Nov;39(11):1042-55. doi: 10.1111/j.1600-051X.2012.01883.x. Epub 2012 Sep 7.
- Background Baker K. Mouthrinses in the prevention and treatment of periodontal disease. Curr Opin Periodontol. 1993:89-96.
- Background Tartaglia GM, Kumar S, Fornari CD, Corti E, Connelly ST. Mouthwashes in the 21st century: a narrative review about active molecules and effectiveness on the periodontal outcomes. Expert Opin Drug Deliv. 2017 Aug;14(8):973-982. doi: 10.1080/17425247.2017.1260118. Epub 2016 Nov 20.
- Background Newman DJ, Cragg GM. Natural Products as Sources of New Drugs from 1981 to 2014. J Nat Prod. 2016 Mar 25;79(3):629-61. doi: 10.1021/acs.jnatprod.5b01055. Epub 2016 Feb 7.
- Background Lazar V, Saviuc CM, Chifiriuc MC. Periodontitis and Periodontal Disease - Innovative Strategies for Reversing the Chronic Infectious and Inflammatory Condition by Natural Products. Curr Pharm Des. 2016;22(2):230-7. doi: 10.2174/138161282202151221124307.
- Background Araujo MWB, Charles CA, Weinstein RB, McGuire JA, Parikh-Das AM, Du Q, Zhang J, Berlin JA, Gunsolley JC. Meta-analysis of the effect of an essential oil-containing mouthrinse on gingivitis and plaque. J Am Dent Assoc. 2015 Aug;146(8):610-622. doi: 10.1016/j.adaj.2015.02.011.
- Background Freires IA, Denny C, Benso B, de Alencar SM, Rosalen PL. Antibacterial Activity of Essential Oils and Their Isolated Constituents against Cariogenic Bacteria: A Systematic Review. Molecules. 2015 Apr 22;20(4):7329-58. doi: 10.3390/molecules20047329.
- Background Van Leeuwen MP, Slot DE, Van der Weijden GA. Essential oils compared to chlorhexidine with respect to plaque and parameters of gingival inflammation: a systematic review. J Periodontol. 2011 Feb;82(2):174-94. doi: 10.1902/jop.2010.100266. Epub 2010 Nov 2.
- Background Barros L, Carvalho AM, Ferreira IC. Leaves, flowers, immature fruits and leafy flowered stems of Malva sylvestris: a comparative study of the nutraceutical potential and composition. Food Chem Toxicol. 2010 Jun;48(6):1466-72. doi: 10.1016/j.fct.2010.03.012. Epub 2010 Mar 15.
- Background Gasparetto JC, Martins CA, Hayashi SS, Otuky MF, Pontarolo R. Ethnobotanical and scientific aspects of Malva sylvestris L.: a millennial herbal medicine. J Pharm Pharmacol. 2012 Feb;64(2):172-89. doi: 10.1111/j.2042-7158.2011.01383.x. Epub 2011 Nov 4.
- Background Razavi SM, Zarrini G, Molavi G, Ghasemi G. Bioactivity of malva sylvestris L., a medicinal plant from iran. Iran J Basic Med Sci. 2011 Nov;14(6):574-9.
- Background Guarrera PM. Traditional phytotherapy in Central Italy (Marche, Abruzzo, and Latium). Fitoterapia. 2005 Jan;76(1):1-25. doi: 10.1016/j.fitote.2004.09.006.
- Background DellaGreca M, Cutillo F, D'Abrosca B, Fiorentino A, Pacifico S, Zarrelli A. Antioxidant and radical scavenging properties of Malva sylvestris. Nat Prod Commun. 2009 Jul;4(7):893-6.
- Background Benso B, Rosalen PL, Alencar SM, Murata RM. Malva sylvestris Inhibits Inflammatory Response in Oral Human Cells. An In Vitro Infection Model. PLoS One. 2015 Oct 19;10(10):e0140331. doi: 10.1371/journal.pone.0140331. eCollection 2015.
- Background Benso B, Franchin M, Massarioli AP, Paschoal JA, Alencar SM, Franco GC, Rosalen PL. Anti-Inflammatory, Anti-Osteoclastogenic and Antioxidant Effects of Malva sylvestris Extract and Fractions: In Vitro and In Vivo Studies. PLoS One. 2016 Sep 19;11(9):e0162728. doi: 10.1371/journal.pone.0162728. eCollection 2016.
- Background Offenbacher S, Barros SP, Beck JD. Rethinking periodontal inflammation. J Periodontol. 2008 Aug;79(8 Suppl):1577-84. doi: 10.1902/jop.2008.080220.
- Background Jeffcoat MK, McGuire M, Newman MG. Evidence-based periodontal treatment. Highlights from the 1996 World Workshop in Periodontics. J Am Dent Assoc. 1997 Jun;128(6):713-24. doi: 10.14219/jada.archive.1997.0294.
- Background DRIPPS RD, LAMONT A, ECKENHOFF JE. The role of anesthesia in surgical mortality. JAMA. 1961 Oct 21;178:261-6. doi: 10.1001/jama.1961.03040420001001. No abstract available.
- Background Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
- Background Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
- Background O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | M. sylvestris extract | Traditional medicine (herbal / TCM) | 10 % | Oral |
| Subject | M. sylvestris extract | Traditional medicine (herbal / TCM) | 10 ml | Oral |
| Subject | experimental group 10% mouthwash of M. sylvestris extract | Unknown | 0.12 % | Oral |
| Subject | experimental group 10% mouthwash of M. sylvestris extract | Unknown | 10 ml | Oral |