Anticariogenic Effect of Moringa Oleifera Mouthwash Compared to Chlorhexidine Mouthwash

Sponsor

Misr International University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04575948

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Plaque, Dental Antimicrobial Mouthwash Cytotoxicity	Drug: Moringa Oleifera Drug: Chlorhexidine mouthwash Drug: Base formula	Phase 2/Phase 3

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 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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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