Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash

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

Study Overview

• Status: Recruiting
• Conditions: Dental Diseases
• Intervention / Treatment: Combination product: Listerine total care zero; Combination product: Chlorhexidine Mouthwash (0.2%).

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: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Mohamed Abdelkadir, master; Phone Number: +201117147699; Email: mohamed.awad@dentistry.cu.edu.eg
• Study Contact Backup: Name: Eman Abouauf, Phd; Phone Number: +201001785300; Email: eabouauf@live.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University
    • Contact: Mohamed Abdelkadir, Master

Participation Criteria

Eligibility Criteria

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

Description

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 six will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial count.	viability counts of Mutans Streptococci lactobacilli	Change from the baseline immediate after using mouthwash, at one week after mouthwash and at two weeks after regular use of mouthwash

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Abdelkadir, Study Principal Investigator

Publications and helpful links

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 25, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: intra-oral microorganisms.; cariogenic microorganisms
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Listerine; Chlorhexidine
• Other Study ID Numbers: CEBC-CU-2017-11-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No