NCT04779502

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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 12, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

February 27, 2021

Last Update Submit

March 2, 2021

Conditions

Keywords

oral halitosisoregano essential oilmouthwash

Outcome Measures

Primary Outcomes (1)

  • organoleptic tongue and floss scores

    organoleptic measuements

    9 month

Secondary Outcomes (1)

  • BANA test

    9 month

Study Arms (3)

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

mouthwash containing oregano essential oil

oregano

0.2% chlorhexidine mouthwash

Also known as: chlorhexdine
chlorhexidine
placeboOTHER

distilled water

Also known as: distilled water
placebo

Eligibility Criteria

Age18 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Baghdad

Baghdad, Rasafa, 00964, Iraq

Location

MeSH Terms

Conditions

Halitosis

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • mohamed s albana, director

    univeristy of baghdad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2021

First Posted

March 3, 2021

Study Start

January 12, 2020

Primary Completion

November 15, 2020

Study Completion

November 17, 2020

Last Updated

March 4, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations