NCT03053882

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

February 4, 2017

Last Update Submit

February 12, 2017

Conditions

Keywords

mouth wash , green tea , peppermint , bad breath

Outcome Measures

Primary Outcomes (1)

  • evaluation of changes in organoleptic score

    0-5 organoleptic scale

    baseline,7 days,14 days,21 days

Secondary Outcomes (1)

  • satisfaction of patients

    21 days

Study Arms (2)

green tea and peppermint

ACTIVE COMPARATOR
Other: mouthwash

peppermint and green tea

ACTIVE COMPARATOR
Other: mouthwash

Interventions

mouthwash containing herbal peppermint or green tea

green tea and peppermintpeppermint and green tea

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Halitosis

Interventions

Mouthwashes

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesCosmeticsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
investigator
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Oral Medicine

Study Record Dates

First Submitted

February 4, 2017

First Posted

February 15, 2017

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

February 15, 2017

Record last verified: 2017-02