Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-29 @ 3:43 PM
Study NCT ID:
NCT00972803
Status:
COMPLETED
Last Update Posted:
2009-09-09
First Post:
2009-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D003773', 'term': 'Dental Plaque'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-08', 'studyFirstSubmitDate': '2009-09-08', 'studyFirstSubmitQcDate': '2009-09-08', 'lastUpdatePostDateStruct': {'date': '2009-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effects of pistacia Mutica extract (PM) on de novo plaque formation.', 'timeFrame': 'In a 4 days experimental periods followed by a 10 days wash-out periods.'}], 'secondaryOutcomes': [{'measure': 'staining effects of pistacia Mutica extract in comparison to placebo or Chlorhexidine', 'timeFrame': 'In a 4 days experimental periods followed by a 10 days wash-out periods'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gingivitis', 'dental plaque', 'mouthrinse'], 'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'Dental plaque is a well known etiologic factor for gingivitis. Recently, herbal extracts are a matter of scientific interest to inhibit plaque accumulation on teeth. The purpose of this study was to evaluate the effects of pistacia Mutica (PM) mouth wash on de novo dental plaque plaque formation, gingival inflammation indices and oral microorganisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* had merely gingivitis (pocket depth≤3 mm, no attachment loss)\n* without any fixed or removable oral appliances\n\nExclusion Criteria:\n\n* Individuals who had a history of any relevant systemic diseases\n* Individuals who had a history of any drug usage'}, 'identificationModule': {'nctId': 'NCT00972803', 'briefTitle': 'The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms', 'organization': {'class': 'OTHER', 'fullName': 'Tabriz University'}, 'officialTitle': 'The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms', 'orgStudyIdInfo': {'id': '8660'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pistacia Mutica', 'description': 'The subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days.', 'interventionNames': ['Drug: pistacia Mutica extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'The subjects were asked to use a mouthwash containing Placebo twice a day for 4 days.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine', 'description': 'The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days.', 'interventionNames': ['Drug: Chlorhexidine']}], 'interventions': [{'name': 'pistacia Mutica extract', 'type': 'DRUG', 'description': 'The subjects were asked to use a mouthwash containing pistacia Mutica extract twice a day for 4 days.', 'armGroupLabels': ['pistacia Mutica']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The subjects were asked to use a placebo mouthwash twice a day for 4 days.', 'armGroupLabels': ['placebo']}, {'name': 'Chlorhexidine', 'type': 'DRUG', 'description': 'The subjects were asked to use a mouthwash containing Chlorhexidine twice a day for 4 days.', 'armGroupLabels': ['Chlorhexidine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tabriz', 'state': 'East Azerbaijan Province', 'country': 'Iran', 'facility': 'Drug Applied Science Center, tabriz Univ. of Medical Sciences', 'geoPoint': {'lat': 38.08, 'lon': 46.2919}}], 'overallOfficials': [{'name': 'Reza Pourabbas, DDS,MSD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tabriz University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tabriz University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Reza Pourabbas', 'oldOrganization': 'Faculty of Dentistry, Tabriz Univ. of Medical Sciences'}}}}