Clinical trial

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

Name
PER8273010
Description
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.
Trial arms
Trial start
2024-07-01
Estimated PCD
2024-11-01
Trial end
2024-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Moringa Oleifera
Non toxic Moringa extract with antibacterial and antiplaque effect will be used
Arms:
Moringa Oleifera mouth wash
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.
Arms:
Chlorhexidine
Other names:
Hexitol
Base formula
Base formula is a negative control
Arms:
Base formula of mouth wash
Size
90
Primary endpoint
Gingival index (GI)
21 days
White Spot Lesions
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2024-03-15

1 organization

3 products

5 indications

Indication
Dental Plaque
Indication
Toothache
Indication
Antimicrobial
Indication
Mouthwash
Indication
Cytotoxicity