The Efficacy of Oregano Essential Oil in Reducing Oral Ha... | NCT04779502

Studies
The Efficacy of Oregano Essential Oil in Reducing Oral Halitosis

NCT04779502

Sponsor

MOHAMED SAEED M. ALI

Status

Completed

Last Update Posted

Mar 4, 2021Actual

Enrollment

54Actual

Phase

Not Applicable

Conditions

Halitosis

Interventions

oregawash
corsodyl
placebo

Countries

Iraq

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2020Actual

Primary Completion Date

Nov 15, 2020Actual

Completion Date

Nov 17, 2020Actual

First Submitted Date

Feb 27, 2021

First Submission Date that Met QC Criteria

Feb 27, 2021

First Posted Date

Mar 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2021

Last Update Posted Date

Mar 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
oregano	Experimental	oregawash mouthwash was used twice times daily for 7 days	Other: oregawash
placebo	Placebo Comparator	distilled water was used twice times daily for 7 days	Other: placebo
chlorhexidine	Active Comparator	Corsodyl with 0.2%CHX mouthwash was used twice times daily for 7 days	Other: corsodyl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oregawash	Other	mouthwash containing oregano essential oil	oregano

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
organoleptic tongue and floss scores	organoleptic measuements	9 month

Secondary Outcomes

Measure	Description	Time Frame
BANA test	chair side BANA test	9 month

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

23 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
mohamed s albana, director	univeristy of baghdad	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univeristy of Baghdad		Baghdad	Rasafa	00964	Iraq

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006209	Halitosis

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002710	Chlorhexidine

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided