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Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash

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ClinicalTrials.gov Identifier: NCT03384537
Recruitment Status : Not yet recruiting
First Posted : December 27, 2017
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Awad Mohamed Abdelkadir, Cairo University

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020


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%).




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384537


Contacts
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Contact: Mohamed Abdelkadir, master +201117147699 mohamed.awad@dentistry.cu.edu.eg
Contact: Eman Abouauf, Phd +201001785300 eabouauf@live.com

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Abdelkadir Study Principal Investigator
  Study Documents (Full-Text)

Documents provided by Mohamed Awad Mohamed Abdelkadir, Cairo University:

Additional Information:
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Responsible Party: Mohamed Awad Mohamed Abdelkadir, Master Degree, Cairo University
ClinicalTrials.gov Identifier: NCT03384537     History of Changes
Other Study ID Numbers: CEBC-CU-2017-11-45
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Listerine
Sodium Fluoride
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Dermatologic Agents
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs