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Efficacy of Peppermint and Green Tea in Malodor

Primary Purpose

Bad Breath

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mouthwash
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bad Breath focused on measuring mouth wash , green tea , peppermint , bad breath

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

organoleptic number equal to or higher 2 no foods (garlic and onion) 48 hours before organoleptic test

Exclusion Criteria:

systemic disease

  • use of antibiotics during study use of other mouthwash during study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    green tea and peppermint

    peppermint and green tea

    Arm Description

    Outcomes

    Primary Outcome Measures

    evaluation of changes in organoleptic score
    0-5 organoleptic scale

    Secondary Outcome Measures

    satisfaction of patients
    questionnaire

    Full Information

    First Posted
    February 4, 2017
    Last Updated
    February 12, 2017
    Sponsor
    Shahid Beheshti University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03053882
    Brief Title
    Efficacy of Peppermint and Green Tea in Malodor
    Official Title
    Comparative Study of the Effects of Green Tea and Peppermint Herbal Mouthwash on Halitosis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shahid Beheshti University of Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Background: Herbal remedies can have the role of prevention and control of bad breath Since in the previous studies, therapeutic and antibacterial effect of green tea and peppermint had been proven .we studied and compared the effects of green tea and peppermint mouthwashes on halitosis. Materials and Methods: This single-blind clinical trial study with cross over design total of 88 volunteer dental students who complained bad breath and had organoleptic score (>= 2) and higher average test scores were enrolled. The students were divided randomly into two groups Green Tea - Peppermint were assigned. Organoleptic test in the baseline, on the 7 day, 14 and 21 measured after rinsing the mouthwashes .As well as the satisfaction of both plants on the last day was considered. Data analysis was performed using tests; Wilcoxon signed rank test, Mann Whithney u, GEE (Generalized Estimating Equation -ordinal logistic regression).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bad Breath
    Keywords
    mouth wash , green tea , peppermint , bad breath

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    investigator
    Allocation
    Randomized
    Enrollment
    88 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    green tea and peppermint
    Arm Type
    Active Comparator
    Arm Title
    peppermint and green tea
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    mouthwash
    Intervention Description
    mouthwash containing herbal peppermint or green tea
    Primary Outcome Measure Information:
    Title
    evaluation of changes in organoleptic score
    Description
    0-5 organoleptic scale
    Time Frame
    baseline,7 days,14 days,21 days
    Secondary Outcome Measure Information:
    Title
    satisfaction of patients
    Description
    questionnaire
    Time Frame
    21 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: organoleptic number equal to or higher 2 no foods (garlic and onion) 48 hours before organoleptic test Exclusion Criteria: systemic disease use of antibiotics during study use of other mouthwash during study

    12. IPD Sharing Statement

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    Efficacy of Peppermint and Green Tea in Malodor

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