Anticariogenic Effect of Moringa Oleifera Mouthwash Compared to Chlorhexidine Mouthwash

ConditionsPlaque, Dental Antimicrobial Mouthwash Cytotoxicity

Trial statusNot yet recruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18-50

SponsorMisr International University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Moringa Oleifera
Drug
Non toxic Moringa extract with antibacterial and antiplaque effect will be used
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.
Base formula
Drug
Base formula is a negative control

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Moringa Oleifera mouth washExperimental treatment 1 intervention

Group B: Base formula of mouth washPlacebo comparator 1 intervention

Group C: ChlorhexidineActive comparator 1 intervention

Trial outcomes

Primary outcomes

Gingival index (GI)

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

Time frame

21 days

White Spot Lesions

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

Time frame

21 days

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Misr International University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: