Efficacy of Licorice on Reducing Salivary Streptococcus Mutans Versus Chlorohexidine in Caries Risk Patients

July 17, 2018 updated by: Nancy Helmy Blamon Mikhael, Cairo University

Evaluation the Efficacy of a Herbal Licorice on Reducing Salivary Streptococcus Mutans Levels (A Randomized Clinical Trial)

To compare the effect of a natural herbal licorice containing preventive measure alternative to chlorohexidine preventive measure to decrease the effect of streptococcus mutans.

Study Overview

Detailed Description

A total number of fifty-two patients will be enrolled in the study. They will be divided into two groups: study group and control group. Study group will be subjected to licorice mouthwash and the control will be subjected to chlorohexidine mouth wash. Salivary bacterial count will be evaluated for both groups.

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • over 18 years old
  • co-operative patients
  • not allergic to licorice
  • not allergic to chlorohexidine

Exclusion Criteria:

  • pregnancy
  • allergic patients to licorice
  • allergic patients to chlorohexidine
  • lack of compliance
  • evidence of parafunctional habits
  • patients with periodontal disease
  • xerostomia
  • participants that receive any microbial agent two weeks prior to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: licorice extract mouthwash
administration of a mouthwash containing licorice as a preventive measure to high caries risk patients (faculty of pharmacy, cairo university)
mouth rinse that contains a natural herbal licorice root extract used as a preventive measure that reduce caries index.
PLACEBO_COMPARATOR: chlorohexidine mouthwash
administration of chlorohexidine 0.2% in 1:1 diluation mouthwash that is broad spectrum antimicrobial activity to high caries risk patients
mouth wash that contains chlorohexidine as an active component

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
salivary bacterial count
Time Frame: after one week
streotococcus mutans bacterial count
after one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: nancy helmy, Msc, Faculty of Dentistry, Cairo univerisity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2018

Primary Completion (ANTICIPATED)

August 30, 2019

Study Completion (ANTICIPATED)

October 1, 2019

Study Registration Dates

First Submitted

July 5, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (ACTUAL)

July 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CEBD-CU-2018-07-5

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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