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
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
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
NCT ID
NCT03053882
First Posted
February 4, 2017
Last Updated
February 12, 2017
Sponsor
Shahid Beheshti University of Medical Sciences
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
Learn more about this trial
Efficacy of Peppermint and Green Tea in Malodor
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