Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT04779502
Status:
COMPLETED
Last Update Posted:
2021-03-04
First Post:
2021-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy of Oregano Essential Oil in Reducing Oral Halitosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006209', 'term': 'Halitosis'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002710', 'term': 'Chlorhexidine'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2021-02-27', 'studyFirstSubmitQcDate': '2021-02-27', 'lastUpdatePostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'organoleptic tongue and floss scores', 'timeFrame': '9 month', 'description': 'organoleptic measuements'}], 'secondaryOutcomes': [{'measure': 'BANA test', 'timeFrame': '9 month', 'description': 'chair side BANA test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral halitosis', 'oregano essential oil', 'mouthwash'], 'conditions': ['Halitosis']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'the results showed that oregawash showed a comparable effect to chx in reducing oral halitosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '23 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Organoleptic score was \\>2 at baseline.\n2. Participants between 18-23 years of age.\n3. The subjects had no systemic disease and were not taking antibiotics or receiving other antimicrobial therapy.\n4. The subjects did not receive the same time treatment for their halitosis.\n\nExclusion Criteria:\n\n1. Smokers, alcoholics and drug addicts.\n2. Patients with periodontitis or pocket depth \\>6 mm.\n3. Patients taking drugs which induced xerostomia.\n4. Subjects consuming spicy food: garlic or onions two days before examination.\n5. Patients with orthodontic appliances or removable dentures.\n6. pregnancy'}, 'identificationModule': {'nctId': 'NCT04779502', 'briefTitle': 'The Efficacy of Oregano Essential Oil in Reducing Oral Halitosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'The Efficacy of Oregano Essential Oil in Reducing Oral Halitosis :A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '131619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oregano', 'description': 'oregawash mouthwash was used twice times daily for 7 days', 'interventionNames': ['Other: oregawash']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'distilled water was used twice times daily for 7 days', 'interventionNames': ['Other: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'chlorhexidine', 'description': 'Corsodyl with 0.2%CHX mouthwash was used twice times daily for 7 days', 'interventionNames': ['Other: corsodyl']}], 'interventions': [{'name': 'oregawash', 'type': 'OTHER', 'description': 'mouthwash containing oregano essential oil', 'armGroupLabels': ['oregano']}, {'name': 'corsodyl', 'type': 'OTHER', 'otherNames': ['chlorhexdine'], 'description': '0.2% chlorhexidine mouthwash', 'armGroupLabels': ['chlorhexidine']}, {'name': 'placebo', 'type': 'OTHER', 'otherNames': ['distilled water'], 'description': 'distilled water', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00964', 'city': 'Baghdad', 'state': 'Rasafa', 'country': 'Iraq', 'facility': 'Univeristy of Baghdad', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}], 'overallOfficials': [{'name': 'mohamed s albana, director', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'univeristy of baghdad'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MOHAMED SAEED M. ALI', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'MOHAMED SAEED M. ALI', 'investigatorAffiliation': 'University of Baghdad'}}}}