The Efficacy of Oregano Essential Oil in Reducing Oral Halitosis
Primary Purpose
Halitosis
Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
oregawash
corsodyl
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Halitosis focused on measuring oral halitosis, oregano essential oil, mouthwash
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Univeristy of Baghdad
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
oregano
placebo
chlorhexidine
Arm Description
oregawash mouthwash was used twice times daily for 7 days
distilled water was used twice times daily for 7 days
Corsodyl with 0.2%CHX mouthwash was used twice times daily for 7 days
Outcomes
Primary Outcome Measures
organoleptic tongue and floss scores
organoleptic measuements
Secondary Outcome Measures
BANA test
chair side BANA test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04779502
Brief Title
The Efficacy of Oregano Essential Oil in Reducing Oral Halitosis
Official Title
The Efficacy of Oregano Essential Oil in Reducing Oral Halitosis :A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 12, 2020 (Actual)
Primary Completion Date
November 15, 2020 (Actual)
Study Completion Date
November 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
MOHAMED SAEED M. ALI
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
Detailed Description
the results showed that oregawash showed a comparable effect to chx in reducing oral halitosis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis
Keywords
oral halitosis, oregano essential oil, mouthwash
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oregano
Arm Type
Experimental
Arm Description
oregawash mouthwash was used twice times daily for 7 days
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
distilled water was used twice times daily for 7 days
Arm Title
chlorhexidine
Arm Type
Active Comparator
Arm Description
Corsodyl with 0.2%CHX mouthwash was used twice times daily for 7 days
Intervention Type
Other
Intervention Name(s)
oregawash
Intervention Description
mouthwash containing oregano essential oil
Intervention Type
Other
Intervention Name(s)
corsodyl
Other Intervention Name(s)
chlorhexdine
Intervention Description
0.2% chlorhexidine mouthwash
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
distilled water
Intervention Description
distilled water
Primary Outcome Measure Information:
Title
organoleptic tongue and floss scores
Description
organoleptic measuements
Time Frame
9 month
Secondary Outcome Measure Information:
Title
BANA test
Description
chair side BANA test
Time Frame
9 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed s albana, director
Organizational Affiliation
univeristy of baghdad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Baghdad
City
Baghdad
State/Province
Rasafa
ZIP/Postal Code
00964
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of Oregano Essential Oil in Reducing Oral Halitosis
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