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RecruitingNCT03384537Updated Mar 19, 2026

Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash

An Early Phase 1 interventional study of Listerine total care zero and Chlorhexidine Mouthwash (0.2%). in Dental Diseases, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Cairo University · Early Phase 1, Interventional, and Prevention

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 9 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Dental Diseases

Keywords

  • intra-oral microorganisms.
  • cariogenic microorganisms
03

In context

Stomatognathic Diseases

80 studies on the registry are indexed under Stomatognathic Diseases; 14 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 59 interventional studies indexed under Stomatognathic Diseases.

Browse Stomatognathic Diseases studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients should be between 18- 45 years of age.
  2. All the volunteers participated in this study will be healthy looking with free medical history.
  3. The volunteers will be asked to suspend their usual oral hygiene practice from two to four days before experiment studying.

Exclusion criteria

Exclusion Criteria:

  1. Patients with a compromised medical condition.
  2. Volunteers that receive any antimicrobial agent during at least two weeks prior to study.
  3. Volunteer with fixed, removable prosthesis or orthodontics appliance.
  4. Volunteers with DMF above six will be excluded.
05

Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Listerine total care zero

    Listerine total care zero

    Combination Product: Listerine total care zero

  • Active comparator
    Chlorhexidine Mouthwash (0.2%).

    Chlorhexidine Mouthwash (0.2%).

    Combination Product: Chlorhexidine Mouthwash (0.2%).

Interventions

  • Combination productListerine total care zero

    reducing intra-oral cariogenic microorganism.

  • Combination productChlorhexidine Mouthwash (0.2%).

    Chlorhexidine Mouthwash (0.2%).

06

What researchers measure

Primary outcomes

  1. Bacterial count.

    viability counts of Mutans Streptococci lactobacilli

    Time frame: Change from the baseline immediate after using mouthwash, at one week after mouthwash and at two weeks after regular use of mouthwash

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03384537
Lead sponsor
Cairo University
Responsible party
Mohamed Awad Mohamed Abdelkadir (Master Degree, Cairo University) — Principal investigator
First posted
Dec 27, 2017
Start date
Feb 8, 2024
Primary completion
Oct 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Mar 19, 2026

Study contacts

Mohamed Abdelkadir, master
Contact
mohamed.awad@dentistry.cu.edu.eg
+201117147699
Eman Abouauf, Phd
Contact
eabouauf@live.com
+201001785300
Abdelkadir
principal investigator · Study Principal Investigator

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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