Anticariogenic Effect of Moringa Oleifera Mouthwash Compared to Chlorhexidine Mouthwash

Official title

Antibacterial, Antiplaque and Anticariogenic Effect of Moringa Oleifera Mouthwash Compared to Chlorhexidine Mouthwash: A Randomized Clinical Trial

Overview

Moringa oleifera (MO) is an extraordinary nutritious vegetable tree with high medicinal value for its antibacterial properties. Formulation of various natural dental remedies from this plant and their testing for their effectiveness might yield promising antibacterial, antiplaque and anticariogenic agents with minimal side effects. Aim of the study: Part I: The aim of this in-vitro part of the study is to formulate a nontoxic mouthwash from MO leaves extract, having antimicrobial activity, to be used in part II of the study. Furthermore, stability and efficacy of the developed mouth wash will be evaluated. Part II: The aim of this randomized controlled trial is to evaluate the antibacterial, antiplaque and anticariogenic effect of MO mouthwash compared to chlorhexidine mouthwash.

Detailed description

Statement of the problem: Oral diseases remain a major health problem all over the world. Periodontal diseases and dental caries are the most common non-communicable oral diseases in mankind and the leading cause of tooth loss. Both diseases can lead to nutritional compromise and negative impact on self-esteem and quality of life. As the International situation is now changing towards the use of non- toxic and environmentally friendly products, development of modern drugs from traditional medicinal plants should be emphasized for the control of various human diseases. Moringa oleifera (MO) is an extraordinary nutritious vegetable tree with high medicinal value for its antibacterial properties. Formulation of various natural dental remedies from this plant and their testing for their effectiveness might yield promising antibacterial, antiplaque and anticariogenic agents with minimal side effects.

Aim of the study:

Part I: The aim of this in-vitro part of the study is to formulate a nontoxic mouthwash from MO leaves extract, having antimicrobial activity, to be used in part II of the study. Furthermore, stability and efficacy of the developed mouth wash will be evaluated.

Part II: The aim of this randomized controlled trial is to evaluate the antibacterial, antiplaque and anticariogenic effect of MO mouthwash compared to chlorhexidine mouthwash.

Materials and Methods:

Part I: In this part of the study; MO leaves will be extracted using different solvents. The active constituents in the form of total phenolic content (TPC) and total flavonoid content (TFC) of the developed extract will be assayed. All the prepared extracts will be evaluated for their antibacterial activity against S. mutans and P. gingivalis. The MO extract(s), which have the highest antibacterial activity will be tested for the cytotoxicity effect on gingival fibroblast cells using cell culture facilities and MTT \[3-(4, 5-dimethylthiazol-2-yl)-2, 5-diphenyl tetrazolium bromide\] assay. The MO mouth wash will be prepared after determination of the minimum inhibitory concentration (MIC) for the extract with the highest antibacterial activity and non-cytotoxic effect. Eventually stability and efficacy of the developed mouth wash will be tested under different storage conditions.

Part II: A triple-blind, parallel arm, randomized controlled clinical trial involving 90 patients with biofilm-induced gingivitis (plaque-induced gingivitis) and moderate-high caries risk will be carried out. Patients will be divided equally into three groups and will receive either the base formula mouthwash (BF; negative control), MO incorporated into the base formula mouthwash or commercial 0.12% Chlorhexidine HCL mouthwash (Hexitol®, H; positive control). After professional oral prophylaxis (scaling and polishing), clinical parameters measurement (gingival index, plaque index, modified sulcular bleeding index, stain index) will be determined for the project. Unstimulated saliva and plaque samples for Streptococcus mutans colony forming units (CFU) will be collected at baseline, 7th, 14th and 21st days. Salivary flow, salivary pH and International Caries Detection and Assessment System II (ICDAS II), will be recorded at baseline, 21st day, 3 months and 6 months.

Interventions

• Drug Moringa Oleifera
  Non toxic Moringa extract with antibacterial and antiplaque effect will be used
• Drug Chlorhexidine mouthwash
  Commercial 0.12% chlorhexidine digluconate mouthwash twice daily (each morning and before bedtime during the 21-day study period) after intake of food. The patient will be asked to use 15 ml of mouthwash swish it for 60 sec. then expectorate.
• Drug Base formula
  Base formula is a negative control

Primary outcome measures

• Gingival index (GI) [Time frame: 21 days]
• White Spot Lesions [Time frame: 21 days]

Eligibility criteria

Inclusion criteria

• Systemically free as reported by the patients
• Minimum of 20 teeth present in the dentition (excluding wisdom teeth);
• Clinically healthy gingiva (on intact periodontium)
• Dental biofilm-induced gingivitis (plaque induced gingivitis) according to the criteria set by the American Academy of Periodontology for classification of periodontal diseases and conditions in 2017
• Moderate to high caries risk patients

Exclusion criteria

• Patients with periodontitis or requiring other immediate dental treatments (within the current 6 months)
• Subjects on antibiotics within last 6 months
• Periodontal therapy for the past 6 months
• Pregnant women and lactating mothers
• Medically compromised patients
• Subjects with tobacco consumption in any form
• Subjects wearing partial dentures or having clinically unacceptable restorations or bridges
• Subjects wearing orthodontic appliances
• History of allergy to chemical or any herbal products

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Marsh PD. Dental plaque as a microbial biofilm. Caries Res. 2004 May-Jun;38(3):204-11. doi: 10.1159/000077756. PMID 15153690
• Marsh PD, Martin MV. Oral microbiology. 5th edition. Edinburgh (UK): Churchil Livingstone; 2009. P 92-110
• Tanzer JM, Livingston J, Thompson AM. The microbiology of primary dental caries in humans. J Dent Educ. 2001 Oct;65(10):1028-37. PMID 11699974
• Loesche WJ. Role of Streptococcus mutans in human dental decay. Microbiol Rev. 1986 Dec;50(4):353-80. doi: 10.1128/mr.50.4.353-380.1986. No abstract available. PMID 3540569
• Marsh PD, Nyvad B. The oral microflora and biofilms on teeth. In: Fejerskov O, Kidd E, editors. Dental caries. The disease and its clinical management. 2nd edition. Oxford: Blackwell; 2008. p. 163-87.
• Marsh PD. Microbiology of dental plaque biofilms and their role in oral health and caries. Dent Clin North Am. 2010 Jul;54(3):441-54. doi: 10.1016/j.cden.2010.03.002. PMID 20630188
• Silverstone LM, Hicks MJ, Featherstone MJ. Dynamic factors affecting lesion initiation and progression in human dental enamel. Part I. The dynamic nature of enamel caries. Quintessence Int. 1988 Oct;19(10):683-711. No abstract available. PMID 3269557
• Al-Obaidi R, Salehi H, Desoutter A, Bonnet L, Etienne P, Terrer E, Jacquot B, Levallois B, Tassery H, Cuisinier FJG. Chemical & Nano-mechanical Study of Artificial Human Enamel Subsurface Lesions. Sci Rep. 2018 Mar 6;8(1):4047. doi: 10.1038/s41598-018-22459-7. PMID 29511281

Identifiers

NCT: NCT04575948 · PER8273010

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗