Bad BreathNCT03053882
Efficacy of Peppermint and Green Tea in Malodor
A study testing mouthwash in people with Bad Breath, run by Shahid Beheshti University of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Bad Breath
- What is being tested?
- mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- organoleptic number equal to or higher 2 no foods (garlic and onion) 48 hours before organoleptic test
Who cannot join
- systemic disease
- use of antibiotics during study use of other mouthwash during study
About this study
Official title: Comparative Study of the Effects of Green Tea and Peppermint Herbal Mouthwash on Halitosis.
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.
Read more
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).
- Conditions
- Bad Breath
- Being tested
- mouthwash
- Keywords
- mouth wash , green tea , peppermint , bad breath
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mouthwashOther
mouthwash containing herbal peppermint or green tea
| Study group | Role | What they receive |
|---|---|---|
| green tea and peppermint | Active comparator | Not described Receives: Other: mouthwash |
| peppermint and green tea | Active comparator | Not described Receives: Other: mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of changes in organoleptic score
0-5 organoleptic scale
Measured: baseline,7 days,14 days,21 days
Secondary outcomes (1)
satisfaction of patients
questionnaire
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startJan 2015
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bad BreathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahin Bakhshi, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053882
- Sponsor's protocol ID
- SBMU
- Status last verified
- Feb 2017
- First submitted
- 4 Feb 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Effects of Green Tea and Peppermint Herbal Mouthwash on Halitosis.
- ClinicalTrials.gov ID
- NCT03053882
- Acronym / sponsor ID
- SBMU
- Conditions
- Bad Breath
- Keywords
- mouth wash , green tea , peppermint , bad breath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| green tea and peppermint | Active comparator | Other: mouthwash |
| peppermint and green tea | Active comparator | Other: mouthwash |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- organoleptic number equal to or higher 2 no foods (garlic and onion) 48 hours before organoleptic test
Key exclusion criteria (2 listed)
- systemic disease
- use of antibiotics during study use of other mouthwash during study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mouthwashmouthwash containing herbal peppermint or green tea | Other | green tea and peppermint, peppermint and green tea |
Primary outcome
evaluation of changes in organoleptic score
Time frame: baseline,7 days,14 days,21 days
0-5 organoleptic scale
1 secondary outcome
satisfaction of patients
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing mouthwash in people with Bad Breath, run by Shahid Beheshti University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of changes in organoleptic score (time frame: baseline,7 days,14 days,21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.