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Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash

Primary Purpose

Dental Diseases

Status
Recruiting
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Listerine total care zero
Chlorhexidine Mouthwash (0.2%).
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Diseases focused on measuring intra-oral microorganisms., cariogenic microorganisms

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Listerine total care zero

Chlorhexidine Mouthwash (0.2%).

Arm Description

Listerine total care zero

Chlorhexidine Mouthwash (0.2%).

Outcomes

Primary Outcome Measures

Bacterial count.
viability counts of Mutans Streptococci lactobacilli

Secondary Outcome Measures

Full Information

First Posted
December 12, 2017
Last Updated
September 3, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03384537
Brief Title
Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash
Official Title
Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash - Randomized Clinical Trail
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2025 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Diseases
Keywords
intra-oral microorganisms., cariogenic microorganisms

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
A third party will perform the allocation sequence and assign the participants to rinsing agent in sequentially numbered opaque envelop.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Listerine total care zero
Arm Type
Experimental
Arm Description
Listerine total care zero
Arm Title
Chlorhexidine Mouthwash (0.2%).
Arm Type
Active Comparator
Arm Description
Chlorhexidine Mouthwash (0.2%).
Intervention Type
Combination Product
Intervention Name(s)
Listerine total care zero
Intervention Description
reducing intra-oral cariogenic microorganism.
Intervention Type
Combination Product
Intervention Name(s)
Chlorhexidine Mouthwash (0.2%).
Intervention Description
Chlorhexidine Mouthwash (0.2%).
Primary Outcome Measure Information:
Title
Bacterial count.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Abdelkadir, master
Phone
+201117147699
Email
mohamed.awad@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Eman Abouauf, Phd
Phone
+201001785300
Email
eabouauf@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelkadir
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdelkadir, Master

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=Efficacy+of+two+mouthwashes+on+3%E2%80%90day+supragingival+plaque+regrowth%3A+a+randomized+crossover+clinical+trial%E2%80%8F
Description
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
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=A+preliminary+investigation+on+the+antimicrobial+activity+of+Listerine%C2%AE%2C+its+components%2C+and+of+mixtures+thereof%E2%80%8F
Description
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.

Learn more about this trial

Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash

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