Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash

NCT03384537 | Recruiting Early Phase 1 DMC

• 1 other identifier: CEBC-CU-2017-11-45
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Diseases

Keywords

intra-oral microorganisms.; cariogenic microorganisms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Listerine total care zero

EXPERIMENTAL

Listerine total care zero

Combination Product: Listerine total care zero

Chlorhexidine Mouthwash (0.2%).

ACTIVE COMPARATOR

Chlorhexidine Mouthwash (0.2%).

Combination Product: Chlorhexidine Mouthwash (0.2%).

Interventions

Listerine total care zero COMBINATION_PRODUCT

reducing intra-oral cariogenic microorganism.

Listerine total care zero

Chlorhexidine Mouthwash (0.2%). COMBINATION_PRODUCT

Chlorhexidine Mouthwash (0.2%).

Chlorhexidine Mouthwash (0.2%).

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 six will be excluded.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

Related 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.

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

• Abdelkadir

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Abdelkadir, master

CONTACT

+201117147699; mohamed.awad@dentistry.cu.edu.eg

Eman Abouauf, Phd

CONTACT

+201001785300; eabouauf@live.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A third party will perform the allocation sequence and assign the participants to rinsing agent in sequentially numbered opaque envelop.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 27, 2017
• Study Start: February 8, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)