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Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03384537
Recruitment Status : Not yet recruiting
First Posted : December 27, 2017
Last Update Posted : March 1, 2019
Information provided by (Responsible Party):
Mohamed Awad Mohamed Abdelkadir, Cairo University

Tracking Information
First Submitted Date  ICMJE December 12, 2017
First Posted Date  ICMJE December 27, 2017
Last Update Posted Date March 1, 2019
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 25, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03384537 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash
Official Title  ICMJE Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash - Randomized Clinical Trail
Brief 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description:
A third party will perform the allocation sequence and assign the participants to rinsing agent in sequentially numbered opaque envelop.
Primary Purpose: Prevention
Condition  ICMJE Dental Diseases
Intervention  ICMJE
  • Combination Product: Listerine total care zero
    reducing intra-oral cariogenic microorganism.
  • Combination Product: Chlorhexidine Mouthwash (0.2%).
    Chlorhexidine Mouthwash (0.2%).
Study Arms  ICMJE
  • Experimental: Listerine total care zero
    Listerine total care zero
    Intervention: Combination Product: Listerine total care zero
  • Active Comparator: Chlorhexidine Mouthwash (0.2%).
    Chlorhexidine Mouthwash (0.2%).
    Intervention: Combination Product: Chlorhexidine Mouthwash (0.2%).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 25, 2017)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  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 will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mohamed Abdelkadir, master +201117147699
Contact: Eman Abouauf, Phd +201001785300
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03384537
Other Study ID Numbers  ICMJE CEBC-CU-2017-11-45
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mohamed Awad Mohamed Abdelkadir, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abdelkadir Study Principal Investigator
PRS Account Cairo University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP