Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash

• ClinicalTrials.gov Identifier: NCT03384537
• Recruitment Status: Active, not recruiting
• First Posted: December 27, 2017
• Last Update Posted: June 7, 2021
• Sponsor: Cairo University
• Information provided by (Responsible Party): Mohamed Awad Mohamed Abdelkadir, Cairo University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Dental Diseases	Combination Product: Listerine total care zero; Combination Product: Chlorhexidine Mouthwash (0.2%).	Early Phase 1

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• 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
• Official Title: Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash - Randomized Clinical Trail
• Actual Study Start Date: January 1, 2021
• Estimated Primary Completion Date: October 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Listerine total care zero; Listerine total care zero	Combination Product: Listerine total care zero; reducing intra-oral cariogenic microorganism.
Active Comparator: Chlorhexidine Mouthwash (0.2%).; Chlorhexidine Mouthwash (0.2%).	Combination Product: Chlorhexidine Mouthwash (0.2%).; Chlorhexidine Mouthwash (0.2%).

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Egypt

Cairo University

Cairo, Egypt

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Abdelkadir; Study Principal Investigator

  Study Documents (Full-Text)

Documents provided by Mohamed Awad Mohamed Abdelkadir, Cairo University:

Study Protocol and Statistical Analysis Plan  [PDF] February 17, 2019

More Information

Additional Information:

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, using 

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. 

• Responsible Party: Mohamed Awad Mohamed Abdelkadir, Master Degree, Cairo University
• ClinicalTrials.gov Identifier: NCT03384537
• Other Study ID Numbers: CEBC-CU-2017-11-45
• First Posted: December 27, 2017
• Last Update Posted: June 7, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohamed Awad Mohamed Abdelkadir, Cairo University:

intra-oral microorganisms.; cariogenic microorganisms

Additional relevant MeSH terms:

Stomatognathic Diseases; Chlorhexidine; Listerine; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants