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

Primary Purpose

Caries, Dental

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
licorice extract mouthwash
chlorohexidine mouthwash
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caries, Dental focused on measuring Streptococcus Mutans, licorice, chlorohexidine, caries index

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    licorice extract mouthwash

    chlorohexidine mouthwash

    Arm Description

    administration of a mouthwash containing licorice as a preventive measure to high caries risk patients (faculty of pharmacy, cairo university)

    administration of chlorohexidine 0.2% in 1:1 diluation mouthwash that is broad spectrum antimicrobial activity to high caries risk patients

    Outcomes

    Primary Outcome Measures

    salivary bacterial count
    streotococcus mutans bacterial count

    Secondary Outcome Measures

    Full Information

    First Posted
    July 5, 2018
    Last Updated
    July 17, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03590977
    Brief Title
    Efficacy of Licorice on Reducing Salivary Streptococcus Mutans Versus Chlorohexidine in Caries Risk Patients
    Official Title
    Evaluation the Efficacy of a Herbal Licorice on Reducing Salivary Streptococcus Mutans Levels (A Randomized Clinical Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2018 (Anticipated)
    Primary Completion Date
    August 30, 2019 (Anticipated)
    Study Completion Date
    October 1, 2019 (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
    To compare the effect of a natural herbal licorice containing preventive measure alternative to chlorohexidine preventive measure to decrease the effect of streptococcus mutans.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caries, Dental
    Keywords
    Streptococcus Mutans, licorice, chlorohexidine, caries index

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    licorice extract mouthwash
    Arm Type
    Experimental
    Arm Description
    administration of a mouthwash containing licorice as a preventive measure to high caries risk patients (faculty of pharmacy, cairo university)
    Arm Title
    chlorohexidine mouthwash
    Arm Type
    Placebo Comparator
    Arm Description
    administration of chlorohexidine 0.2% in 1:1 diluation mouthwash that is broad spectrum antimicrobial activity to high caries risk patients
    Intervention Type
    Other
    Intervention Name(s)
    licorice extract mouthwash
    Intervention Description
    mouth rinse that contains a natural herbal licorice root extract used as a preventive measure that reduce caries index.
    Intervention Type
    Other
    Intervention Name(s)
    chlorohexidine mouthwash
    Intervention Description
    mouth wash that contains chlorohexidine as an active component
    Primary Outcome Measure Information:
    Title
    salivary bacterial count
    Description
    streotococcus mutans bacterial count
    Time Frame
    after one week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    nancy helmy, Msc
    Phone
    01002715841
    Ext
    002
    Email
    nancy.helmy@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    sherine hafez, Phd
    Phone
    01099296591
    Ext
    002
    Email
    sherine.hafez@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    nancy helmy, Msc
    Organizational Affiliation
    Faculty of Dentistry, Cairo univerisity
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27129589
    Citation
    Almaz ME, Sonmez IS, Okte Z, Oba AA. Efficacy of a sugar-free herbal lollipop for reducing salivary Streptococcus mutans levels: a randomized controlled trial. Clin Oral Investig. 2017 Apr;21(3):839-845. doi: 10.1007/s00784-016-1827-y. Epub 2016 Apr 30.
    Results Reference
    background
    PubMed Identifier
    24021323
    Citation
    Jain E, Pandey RK, Khanna R. Liquorice root extracts as potent cariostatic agents in pediatric practice. J Indian Soc Pedod Prev Dent. 2013 Jul-Sep;31(3):146-52. doi: 10.4103/0970-4388.117964.
    Results Reference
    background

    Learn more about this trial

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

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