Dental DiseasesEarly Phase 1NCT03384537
Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash
A Early Phase 1 study testing Listerine total care zero and Chlorhexidine Mouthwash (0.2%). in people with Dental Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
The objective of this study is to compare the effect of Tropolone containing mouthwash versus CHX 0.2% mouthwash in reducing intraoral microorganism. Randomized clinical trial study Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Diseases
- What is being tested?
- Listerine total care zero and Chlorhexidine Mouthwash (0.2%).
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Feb 2024to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients should be between 18- 45 years of age.
- All the volunteers participated in this study will be healthy looking with free medical history.
- The volunteers will be asked to suspend their usual oral hygiene practice from two to four days before experiment studying.
Who cannot join
- Patients with a compromised medical condition.
- Volunteers that receive any antimicrobial agent during at least two weeks prior to study.
- Volunteer with fixed, removable prosthesis or orthodontics appliance.
- Volunteers with DMF above six will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Mohamed Abdelkadir, Master
About this study
Official title: Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash - Randomized Clinical Trail
The objective of this study is to compare the effect of Tropolone containing mouthwash versus CHX 0.2% mouthwash in reducing intraoral microorganism. Randomized clinical trial study
Read the detailed description
Dental Caries disease prevented through the antibacterial mouthwash.
The prevalence of dental caries disease continues to be a challenge for oral health care professionals to this day.
In fact an alarming 92% of US adults (aged 20 to 64 years) have a history of dental caries. While strides have been made since the early 1970s the problem persists.
From the mid1990s until 2004 according to the National Health and Nutrition examination survey there was a small but significant increase in primary decay. This trend was even more severe in younger.
Dental Caries disease are not being treated can eventually turn into more serious issues. Fluoride has long been known as one of the key components to good oral health and the prevention of dental caries disease. It is a naturally occurring mineral that makes tooth enamel more resistant to acid producing bacteria that cause dental caries disease while also repairing teeth in the very early microscopic stages. While the use of fluoride in toothpaste has been responsible for a drop in dental caries disease since 1960 this significant problem still persists.
Yet, many people do not realize that also using a mouth rinse can result in 50% stronger teeth than brushing with fluoride toothpaste alone. The American Dental Association (ADA) recommends the use of mouth rinses with fluoride to help resist tooth decay. However, while it may appear so on the surface, not all fluoride mouth rinses are created the same.
At the Listerine brand, our commitment to innovation led to the creation of unique anti-cavity mouth rinses powered by breakthrough science called rapid fusion technology a unique fluoride delivery system which binds calcium ions with fluoride to create fluoride reservoirs that attach to tooth enamel and are then released over time for a greater fluoride uptake and greater enamel content of fluoride to the tooth surface.
Rapid fusion technology provides fluoride in a safe acidic environment that rapidly liberates calcium and phosphate ions. These ions combine to create millions of tiny fluoride reservoirs on tooth enamel and in saliva increasing the amount of fluoride on the tooth surface.
Throughout the day as enamel is exposed to acids from dietary sugars, the reservoirs dissolve and release fluoride to re-mineralize the teeth. The fluoride then binds to areas of weak demineralized enamel and attracts calcium and phosphate from saliva.
These ions penetrate the enamel and combine with fluoride to create a new stronger and more acid resistant mineral surface. In this way Rapid fusion technology enhances re-mineralization and inhibits demineralization of tooth enamel to provide. stronger teeth than brushing with fluoride toothpaste alone and greater re-mineralization of enamel.
The antimicrobial mouthwash is proved to prevent the development of dental plaque. The use of antimicrobial agents will lead to the avoidance of side effects complained by patients associated with the use of chlorhexidine.
And proving their potency against mutans streptococci will dramatically improve the oral health of patients as it is the major cause of dental plaque.
Dental plaque is reported to be a major health problem in public.
Therefore, reducing the incidence of caries disease through the use of antimicrobial agents will decrease the number of visits of patients complaining of plaque and associated health problems. Also, complaints of patients regarding side effects of will be of no concern to dentists.
- Conditions
- Dental Diseases
- Being tested
- Listerine total care zero, Chlorhexidine Mouthwash (0.2%).
- Keywords
- intra-oral microorganisms., cariogenic microorganisms
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listerine total care zeroCombination product
reducing intra-oral cariogenic microorganism.
Chlorhexidine Mouthwash (0.2%).Combination product
Chlorhexidine Mouthwash (0.2%).
| Study group | Role | What they receive |
|---|---|---|
| Listerine total care zero | Experimental | Listerine total care zero Receives: Combination Product: Listerine total care zero |
| Chlorhexidine Mouthwash (0.2%). | Active comparator | Chlorhexidine Mouthwash (0.2%). Receives: Combination Product: Chlorhexidine Mouthwash (0.2%). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial count.
viability counts of Mutans Streptococci lactobacilli
Measured: Change from the baseline immediate after using mouthwash, at one week after mouthwash and at two weeks after regular use of mouthwash
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start8 Feb 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental DiseasesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants in this study will be randomly divided into two groups according to the application of the mouth rinse agent (M); the first group M1) The participants will use Tropolone containing as a mouth rinse, the second group (M2) The participants will use chlorhexidine 0.2% as a mouth rinse. Then each participant will be monitoring at the base line T0: before using any mouthwash, T1: immedially after using tested mouthwash, T2: after one week and finally, T3: after two weeks of using the tested mouthwash. Each participant will be the reference/counted for self as a record.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Awad Mohamed Abdelkadir, Cairo University
- Investigators
- Abdelkadir, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384537
- Sponsor's protocol ID
- CEBC-CU-2017-11-45
- Status last verified
- Mar 2026
- First submitted
- 12 Dec 2017
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash - Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT03384537
- Acronym / sponsor ID
- CEBC-CU-2017-11-45
- Conditions
- Dental Diseases
- Keywords
- intra-oral microorganisms., cariogenic microorganisms
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the effect of Tropolone containing mouthwash versus CHX 0.2% mouthwash in reducing intraoral microorganism. Randomized clinical trial study
Detailed description
Dental Caries disease prevented through the antibacterial mouthwash.
The prevalence of dental caries disease continues to be a challenge for oral health care professionals to this day.
In fact an alarming 92% of US adults (aged 20 to 64 years) have a history of dental caries. While strides have been made since the early 1970s the problem persists.
From the mid1990s until 2004 according to the National Health and Nutrition examination survey there was a small but significant increase in primary decay. This trend was even more severe in younger.
Dental Caries disease are not being treated can eventually turn into more serious issues. Fluoride has long been known as one of the key components to good oral health and the prevention of dental caries disease. It is a naturally occurring mineral that makes tooth enamel more resistant to acid producing bacteria that cause dental caries disease while also repairing teeth in the very early microscopic stages. While the use of fluoride in toothpaste has been responsible for a drop in dental caries disease since 1960 this significant problem still persists.
Yet, many people do not realize that also using a mouth rinse can result in 50% stronger teeth than brushing with fluoride toothpaste alone. The American Dental Association (ADA) recommends the use of mouth rinses with fluoride to help resist tooth decay. However, while it may appear so on the surface, not all fluoride mouth rinses are created the same.
At the Listerine brand, our commitment to innovation led to the creation of unique anti-cavity mouth rinses powered by breakthrough science called rapid fusion technology a unique fluoride delivery system which binds calcium ions with fluoride to create fluoride reservoirs that attach to tooth enamel and are then released over time for a greater fluoride uptake and greater enamel content of fluoride to the tooth surface.
Rapid fusion technology provides fluoride in a safe acidic environment that rapidly liberates calcium and phosphate ions. These ions combine to create millions of tiny fluoride reservoirs on tooth enamel and in saliva increasing the amount of fluoride on the tooth surface.
Throughout the day as enamel is exposed to acids from dietary sugars, the reservoirs dissolve and release fluoride to re-mineralize the teeth. The fluoride then binds to areas of weak demineralized enamel and attracts calcium and phosphate from saliva.
These ions penetrate the enamel and combine with fluoride to create a new stronger and more acid resistant mineral surface. In this way Rapid fusion technology enhances re-mineralization and inhibits demineralization of tooth enamel to provide. stronger teeth than brushing with fluoride toothpaste alone and greater re-mineralization of enamel.
The antimicrobial mouthwash is proved to prevent the development of dental plaque. The use of antimicrobial agents will lead to the avoidance of side effects complained by patients associated with the use of chlorhexidine.
And proving their potency against mutans streptococci will dramatically improve the oral health of patients as it is the major cause of dental plaque.
Dental plaque is reported to be a major health problem in public.
Therefore, reducing the incidence of caries disease through the use of antimicrobial agents will decrease the number of visits of patients complaining of plaque and associated health problems. Also, complaints of patients regarding side effects of will be of no concern to dentists.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The participants in this study will be randomly divided into two groups according to the application of the mouth rinse agent (M); the first group M1) The participants will use Tropolone containing as a mouth rinse, the second group (M2) The participants will use chlorhexidine 0.2% as a mouth rinse. Then each participant will be monitoring at the base line T0: before using any mouthwash, T1: immedially after using tested mouthwash, T2: after one week and finally, T3: after two weeks of using the tested mouthwash. Each participant will be the reference/counted for self as a record.
| Arm | Type | Receives |
|---|---|---|
| Listerine total care zero | Experimental | Combination Product: Listerine total care zeroListerine total care zero |
| Chlorhexidine Mouthwash (0.2%). | Active comparator | Combination Product: Chlorhexidine Mouthwash (0.2%).Chlorhexidine Mouthwash (0.2%). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients should be between 18- 45 years of age.
- All the volunteers participated in this study will be healthy looking with free medical history.
- The volunteers will be asked to suspend their usual oral hygiene practice from two to four days before experiment studying.
Key exclusion criteria (4 listed)
- Patients with a compromised medical condition.
- Volunteers that receive any antimicrobial agent during at least two weeks prior to study.
- Volunteer with fixed, removable prosthesis or orthodontics appliance.
- Volunteers with DMF above six will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Listerine total care zeroreducing intra-oral cariogenic microorganism. | Combination product | Listerine total care zero |
| Chlorhexidine Mouthwash (0.2%).Chlorhexidine Mouthwash (0.2%). | Combination product | Chlorhexidine Mouthwash (0.2%). |
Primary outcome
Bacterial count.
Time frame: Change from the baseline immediate after using mouthwash, at one week after mouthwash and at two weeks after regular use of mouthwash
viability counts of Mutans Streptococci lactobacilli
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- BACKGROUND:evaluate the antiplaque effects of an alcohol-free essential oil (alcohol-free EO) mouthwash and an amine fluoride/stannous fluoride with zinc lactate (SnFl-Zn) mouthwash compared to a positive control of chlorhexidine (CHX) mouthwash, usingLink provided by the sponsor.
- Results:demonstrate that the phenols and their concentrations as contained within Listerine® could be further optimized in terms of selecting those which increase their general effectiveness, at concentrations that do not induce harm.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abdelkadir principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Listerine total care zero and Chlorhexidine Mouthwash (0.2%). in people with Dental Diseases, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abdelkadir, master (+201117147699, mohamed.awad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial count. (time frame: Change from the baseline immediate after using mouthwash, at one week after mouthwash and at two weeks after regular use of mouthwash). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.