HalitosisNCT04779502
The Efficacy of Oregano Essential Oil in Reducing Oral Halitosis
A study testing oregawash and corsodyl in people with Halitosis, run by MOHAMED SAEED M. ALI at 1 site in Iraq.
Trial summary
the efficacy of commercially available oregano essential oil mouthwash in the reduction of oral halitosis was compared to chlorhexidine and distilled water and the results showed significant reduction of organoleptic tongue and floss scores and BANA test scores compared to placebo Read more about this study
- Who is it for?
- Ages 18 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Halitosis
- What is being tested?
- oregawash and corsodyl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteIraq
- Study dates
- 12 Jan 2020to 17 Nov 2020
- 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 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Organoleptic score was >2 at baseline.
- Participants between 18-23 years of age.
- The subjects had no systemic disease and were not taking antibiotics or receiving other antimicrobial therapy.
- The subjects did not receive the same time treatment for their halitosis.
Who cannot join
- Smokers, alcoholics and drug addicts.
- Patients with periodontitis or pocket depth >6 mm.
- Patients taking drugs which induced xerostomia.
- Subjects consuming spicy food: garlic or onions two days before examination.
- Patients with orthodontic appliances or removable dentures.
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Oregano Essential Oil in Reducing Oral Halitosis :A Randomized Controlled Trial
the efficacy of commercially available oregano essential oil mouthwash in the reduction of oral halitosis was compared to chlorhexidine and distilled water and the results showed significant reduction of organoleptic tongue and floss scores and BANA test scores compared to placebo
Read the detailed description
the results showed that oregawash showed a comparable effect to chx in reducing oral halitosis
- Conditions
- Halitosis
- Being tested
- oregawash, corsodyl, placebo
- Keywords
- oral halitosis, oregano essential oil, mouthwash
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oregawashOther
mouthwash containing oregano essential oil
corsodylOther
Also called chlorhexdine
0.2% chlorhexidine mouthwash
placeboOther
Also called distilled water
distilled water
| Study group | Role | What they receive |
|---|---|---|
| oregano | Experimental | oregawash mouthwash was used twice times daily for 7 days Receives: Other: oregawash |
| placebo | Placebo comparator | distilled water was used twice times daily for 7 days Receives: Other: placebo |
| chlorhexidine | Active comparator | Corsodyl with 0.2%CHX mouthwash was used twice times daily for 7 days Receives: Other: corsodyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
organoleptic tongue and floss scores
organoleptic measuements
Measured: 9 month
Secondary outcomes (1)
BANA test
chair side BANA test
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start12 Jan 2020
- Primary completion15 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HalitosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- MOHAMED SAEED M. ALI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MOHAMED SAEED M. ALI, University of Baghdad
- Investigators
- mohamed s albana, director, Principal investigator, univeristy of baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779502
- Sponsor's protocol ID
- 131619
- Status last verified
- Mar 2021
- First submitted
- 27 Feb 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Oregano Essential Oil in Reducing Oral Halitosis :A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04779502
- Acronym / sponsor ID
- 131619
- Conditions
- Halitosis
- Keywords
- oral halitosis, oregano essential oil, mouthwash
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- MOHAMED SAEED M. ALIUniversity, hospital or other
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 3 Mar 2021 (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.
the efficacy of commercially available oregano essential oil mouthwash in the reduction of oral halitosis was compared to chlorhexidine and distilled water and the results showed significant reduction of organoleptic tongue and floss scores and BANA test scores compared to placebo
Detailed description
the results showed that oregawash showed a comparable effect to chx in reducing oral halitosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| oregano | Experimental | Other: oregawashoregawash mouthwash was used twice times daily for 7 days |
| placebo | Placebo comparator | Other: placebodistilled water was used twice times daily for 7 days |
| chlorhexidine | Active comparator | Other: corsodylCorsodyl with 0.2%CHX mouthwash was used twice times daily for 7 days |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Organoleptic score was >2 at baseline.
- Participants between 18-23 years of age.
- The subjects had no systemic disease and were not taking antibiotics or receiving other antimicrobial therapy.
- The subjects did not receive the same time treatment for their halitosis.
Key exclusion criteria (6 listed)
- Smokers, alcoholics and drug addicts.
- Patients with periodontitis or pocket depth >6 mm.
- Patients taking drugs which induced xerostomia.
- Subjects consuming spicy food: garlic or onions two days before examination.
- Patients with orthodontic appliances or removable dentures.
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 |
|---|---|---|
| oregawashmouthwash containing oregano essential oil | Other | oregano |
| corsodylAlso: chlorhexdine0.2% chlorhexidine mouthwash | Other | chlorhexidine |
| placeboAlso: distilled waterdistilled water | Other | placebo |
Primary outcome
organoleptic tongue and floss scores
Time frame: 9 month
organoleptic measuements
1 secondary outcome
BANA test
Time frame: 9 month
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 4 Mar 2021.
- Individual participant dataSharing planned: No
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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.
mohamed s albana, director principal investigator
univeristy of baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oregawash and corsodyl in people with Halitosis, run by MOHAMED SAEED M. ALI at 1 site in Iraq.
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 4 inclusion and 6 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 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
organoleptic tongue and floss scores (time frame: 9 month). 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 4 Mar 2021.