Anticariogenic Effect of Moringa Oleifera Mouthwash Compared to Chlorhexidine Mouthwash

January 26, 2026 updated by: Misr International University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moringa Oleifera mouth wash
According to part I of the study, we will select the most effective (Non-toxic, anti-bacterial effect) Moringa extract to prepare the mouth wash.
Drug: Moringa Oleifera
Non toxic Moringa extract with antibacterial and antiplaque effect will be used
Placebo Comparator: Base formula of mouth wash
Base formula of mouthwash
Drug: Base formula
Base formula is a negative control
Active Comparator: Chlorhexidine
Commercial 0.12% chlorhexidine digluconate mouthwash
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.
Other Names:
  • Hexitol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival index (GI)
Time Frame: 21 days
as assessed by Lӧe and Silness: Score from 0 to 3, Zero is normal subject
21 days
White Spot Lesions
Time Frame: 21 days
Assessed by ICDAS II: Scores from 0 to 9: Zero is unrestored or unsealed tooth surface
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Misr International University

Investigators

  • Study Chair: Mahassen M Farghaly, Professor, Vice president of community services and environmental awareness

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2027

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PER8273010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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