Plaque, DentalPhase 2/3NCT04575948
Anticariogenic Effect of Moringa Oleifera Mouthwash Compared to Chlorhexidine Mouthwash
A Phase 2/3 study testing Moringa Oleifera, Chlorhexidine mouthwash and Base formula in people with Plaque, Dental and Antimicrobial, run by Misr International University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Plaque, Dental, Antimicrobial, Mouthwash
- What is being tested?
- Moringa Oleifera, Chlorhexidine mouthwash and Base formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Dec 2027to Dec 2028
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Subjects wearing partial dentures or having clinically unacceptable restorations or bridges
- Subjects wearing orthodontic appliances
- History of allergy to chemical or any herbal products
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Plaque, Dental, Antimicrobial, Mouthwash, Cytotoxicity
- Being tested
- Moringa Oleifera, Chlorhexidine mouthwash, Base formula
- Keywords
- Moringa Oleifera, antibacterial activity, mouthwash, chlorhexidine, antiplaque, herbal, translational research
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa OleiferaDrug
Non toxic Moringa extract with antibacterial and antiplaque effect will be used
Chlorhexidine mouthwashDrug
Also called Hexitol
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 formulaDrug
Base formula is a negative control
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Moringa Oleifera |
| Base formula of mouth wash | Placebo comparator | Base formula of mouthwash Receives: Drug: Base formula |
| Chlorhexidine | Active comparator | Commercial 0.12% chlorhexidine digluconate mouthwash Receives: Drug: Chlorhexidine mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival index (GI)
as assessed by Lӧe and Silness: Score from 0 to 3, Zero is normal subject
Measured: 21 days
White Spot Lesions
Assessed by ICDAS II: Scores from 0 to 9: Zero is unrestored or unsealed tooth surface
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study startDec 2027 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Plaque, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahassen M Farghaly, Professor, Study chair, Vice president of community services and environmental awareness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575948
- Sponsor's protocol ID
- PER8273010
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2020
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marsh PD. Dental plaque as a microbial biofilm. Caries Res. 2004 May-Jun;38(3):204-11. doi: 10.1159/000077756.
PubMed 15153690Marsh PD, Martin MV. Oral microbiology. 5th edition. Edinburgh (UK): Churchil Livingstone; 2009. P 92-110
Tanzer JM, Livingston J, Thompson AM. The microbiology of primary dental caries in humans. J Dent Educ. 2001 Oct;65(10):1028-37.
PubMed 11699974Loesche WJ. Role of Streptococcus mutans in human dental decay. Microbiol Rev. 1986 Dec;50(4):353-80. doi: 10.1128/mr.50.4.353-380.1986. No abstract available.
PubMed 3540569Marsh PD, Nyvad B. The oral microflora and biofilms on teeth. In: Fejerskov O, Kidd E, editors. Dental caries. The disease and its clinical management. 2nd edition. Oxford: Blackwell; 2008. p. 163-87.
Marsh PD. Microbiology of dental plaque biofilms and their role in oral health and caries. Dent Clin North Am. 2010 Jul;54(3):441-54. doi: 10.1016/j.cden.2010.03.002.
PubMed 20630188Silverstone LM, Hicks MJ, Featherstone MJ. Dynamic factors affecting lesion initiation and progression in human dental enamel. Part I. The dynamic nature of enamel caries. Quintessence Int. 1988 Oct;19(10):683-711. No abstract available.
PubMed 3269557Al-Obaidi R, Salehi H, Desoutter A, Bonnet L, Etienne P, Terrer E, Jacquot B, Levallois B, Tassery H, Cuisinier FJG. Chemical & Nano-mechanical Study of Artificial Human Enamel Subsurface Lesions. Sci Rep. 2018 Mar 6;8(1):4047. doi: 10.1038/s41598-018-22459-7.
PubMed 29511281Mini KJ, Anulekh B, Anupama G. Incipient caries: an early intervention approach. Int J Community Med Public Health 2015; 2(1):10-14
Wennerholm K, Lindquist B, Emilson CG. The toothpick method in relation to other plaque sampling techniques for evaluating mutans streptococci. Eur J Oral Sci. 1995 Feb;103(1):36-41. doi: 10.1111/j.1600-0722.1995.tb00008.x.
PubMed 7600248Dasanayake AP, Caufield PW, Cutter GR, Roseman JM, Kohler B. Differences in the detection and enumeration of mutans streptococci due to differences in methods. Arch Oral Biol. 1995 Apr;40(4):345-51. doi: 10.1016/0003-9969(94)00164-7.
PubMed 7605262Pitts N. "ICDAS"--an international system for caries detection and assessment being developed to facilitate caries epidemiology, research and appropriate clinical management. Community Dent Health. 2004 Sep;21(3):193-8. No abstract available.
PubMed 15470828Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
PubMed 17518963Braga MM, Oliveira LB, Bonini GA, Bonecker M, Mendes FM. Feasibility of the International Caries Detection and Assessment System (ICDAS-II) in epidemiological surveys and comparability with standard World Health Organization criteria. Caries Res. 2009;43(4):245-9. doi: 10.1159/000217855. Epub 2009 May 8.
PubMed 19439944Almosa NA, Lundgren T, Bresin A, Birkhed D, Kjellberg H. Diagnosing the severity of buccal caries lesions in orthodontic patients at de-bonding using digital photographs. Acta Odontol Scand. 2014 Aug;72(6):474-80. doi: 10.3109/00016357.2013.865788. Epub 2013 Dec 9.
PubMed 24320004