Anticariogenic Effect of Moringa Oleifera Mouthwash Compared to Chlorhexidine Mouthwash

NCT04575948 | Not Yet Recruiting Phase 2

• 1 other identifier: PER8273010
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Plaque, Dental; Mouthwash; Cytotoxicity; Antimicrobial

Keywords

Moringa Oleifera; antibacterial activity; mouthwash; chlorhexidine; antiplaque; herbal; translational research

Outcome Measures

Primary Outcomes (2)

• Gingival index (GI)

  as assessed by Lӧe and Silness: Score from 0 to 3, Zero is normal subject

  21 days

• White Spot Lesions

  Assessed by ICDAS II: Scores from 0 to 9: Zero is unrestored or unsealed tooth surface

  21 days

Study Arms (3)

Moringa Oleifera mouth wash

EXPERIMENTAL

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

Base formula of mouth wash

PLACEBO COMPARATOR

Base formula of mouthwash

Drug: Base formula

Chlorhexidine

ACTIVE COMPARATOR

Commercial 0.12% chlorhexidine digluconate mouthwash

Drug: Chlorhexidine mouthwash

Interventions

Moringa Oleifera DRUG

Non toxic Moringa extract with antibacterial and antiplaque effect will be used

Moringa Oleifera mouth wash

Base formula DRUG

Base formula is a negative control

Base formula of mouth wash

Chlorhexidine mouthwash DRUG

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.

Also known as: Hexitol

Chlorhexidine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Misr International University: lead

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MeSH Terms

Conditions

Dental Plaque

Interventions

flocculant protein MO 2.1, Moringa oleifera; hexitol

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mahassen M Farghaly, Professor

  Vice president of community services and environmental awareness

  STUDY CHAIR

Central Study Contacts

Mahassen M Farghaly, Professor

CONTACT

01111230345; mahassen.farghaly@miuegypt.edu.eg

Shahinaz G Elashiry, Assoc Prof

CONTACT

01015046065; shahinaz.elashiry@miuegypt.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Masking of all caregivers, examiners (I) and (II), as well as patients are planned. No one other than HSE at the NRC will know which mouthwash is in each bottle. HSE will not be involved in patient recruitment, follow-up or assessment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 5, 2020
• Study Start (Estimated): December 1, 2027
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 27, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share