Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-30 @ 8:42 AM
Study NCT ID:
NCT01236950
Status:
COMPLETED
Last Update Posted:
2010-11-10
First Post:
2010-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of an Essential Oil and a Delmopinol Mouthrinse Effect on Dental Plaque Accumulation Index, Gingivitis Index and on Streptococcus Mutans, Lactobacillus, Aerobic and Anaerobic Oral Bacteria Colony Counts.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C073738', 'term': 'delmopinol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-09', 'studyFirstSubmitDate': '2010-11-08', 'studyFirstSubmitQcDate': '2010-11-08', 'lastUpdatePostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Loe & Silness Gingival Index (1963)', 'timeFrame': 'change from baseline in gingival index at two weeks', 'description': 'data collected at the begining of the study and two weeks after mouthrinse usage.'}, {'measure': 'Quigley, Hein & Turesky Dental Plaque Index (1970)', 'timeFrame': 'change from baseline in plaque index at two weeks', 'description': 'data collected at the begining of the study and two weeks after mouthrinse usage.'}], 'secondaryOutcomes': [{'measure': 'Streptococcus mutans CFU', 'timeFrame': 'change from baseline in CFU counts at two weeks', 'description': 'data collected at the begining of the study and two weeks after mouthrinse usage.'}, {'measure': 'Lactobacillus CFU', 'timeFrame': 'change from baseline in CFU counts at two weeks', 'description': 'data collected at the begining of the study and two weeks after mouthrinse usage.'}, {'measure': 'Aerobic and anaerobic oral bacteria CFU', 'timeFrame': 'change from baseline in CFU counts at two weeks', 'description': 'data collected at the begining of the study and two weeks after mouthrinse usage.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clinical Trial', 'Prevention Mouthrinse'], 'conditions': ['Gingivitis', 'Dental Plaque Accumulation']}, 'referencesModule': {'references': [{'pmid': '8046559', 'type': 'BACKGROUND', 'citation': 'Abbott DM, Gunsolley JC, Koertge TE, Payne EL. The relative efficacy of 0.1% and 0.2% delmopinol mouthrinses in inhibiting the development of supragingival dental plaque and gingivitis in man. J Periodontol. 1994 May;65(5):437-41. doi: 10.1902/jop.1994.65.5.437.'}, {'pmid': '17116159', 'type': 'BACKGROUND', 'citation': 'Addy M, Moran J, Newcombe RG. Meta-analyses of studies of 0.2% delmopinol mouth rinse as an adjunct to gingival health and plaque control measures. J Clin Periodontol. 2007 Jan;34(1):58-65. doi: 10.1111/j.1600-051X.2006.01013.x. Epub 2006 Nov 20.'}, {'pmid': '12974527', 'type': 'BACKGROUND', 'citation': 'Baehni PC, Takeuchi Y. Anti-plaque agents in the prevention of biofilm-associated oral diseases. Oral Dis. 2003;9 Suppl 1:23-9. doi: 10.1034/j.1601-0825.9.s1.5.x.'}, {'pmid': '17035671', 'type': 'BACKGROUND', 'citation': 'Barnett ML. The rationale for the daily use of an antimicrobial mouthrinse. J Am Dent Assoc. 2006 Nov;137 Suppl:16S-21S. doi: 10.14219/jada.archive.2006.0408.'}, {'pmid': '10743861', 'type': 'BACKGROUND', 'citation': 'Fine DH, Furgang D, Barnett ML, Drew C, Steinberg L, Charles CH, Vincent JW. Effect of an essential oil-containing antiseptic mouthrinse on plaque and salivary Streptococcus mutans levels. J Clin Periodontol. 2000 Mar;27(3):157-61. doi: 10.1034/j.1600-051x.2000.027003157.x.'}, {'pmid': '3902908', 'type': 'BACKGROUND', 'citation': 'Gordon JM, Lamster IB, Seiger MC. Efficacy of Listerine antiseptic in inhibiting the development of plaque and gingivitis. J Clin Periodontol. 1985 Sep;12(8):697-704. doi: 10.1111/j.1600-051x.1985.tb00941.x.'}, {'pmid': '12787196', 'type': 'BACKGROUND', 'citation': 'Ouhayoun JP. Penetrating the plaque biofilm: impact of essential oil mouthwash. J Clin Periodontol. 2003;30 Suppl 5:10-2. doi: 10.1034/j.1600-051x.30.s5.4.x.'}]}, 'descriptionModule': {'briefSummary': 'The use of mouthrinses may be of relevance as a complement to daily dental hygiene procedures, especially for patients who do not comply with a proper mechanical removal of dental plaque. Essential oils and delmopinol mouthrinses are effective to reduce dental plaque accumulation and gingivitis. Also an effect on dental bacteria can be found. The study hypothesis states that there are no differences between the mouthrinses on the reduction of gingivitis and dental plaque accumulation as well on the bacterial counts of Streptococcus mutans, Lactobacillus, aerobic and anaerobic bacteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient at the dental hygiene clinic of Faculdade de Medicina Dentária\n* Signature of consent form\n* Have, at least, two quadrant with 6 teeth each\n* Gingival Index at baseline less than 3\n* Presence of dental plaque\n\nExclusion Criteria:\n\n* Use of a mouthrinse\n* Dental Hygiene appointment in the past 6 months\n* Use of antibiotics in teh past 3 months\n* Presence of extensive caries and fractures of teeth'}, 'identificationModule': {'nctId': 'NCT01236950', 'briefTitle': 'Study of an Essential Oil and a Delmopinol Mouthrinse Effect on Dental Plaque Accumulation Index, Gingivitis Index and on Streptococcus Mutans, Lactobacillus, Aerobic and Anaerobic Oral Bacteria Colony Counts.', 'organization': {'class': 'OTHER', 'fullName': 'University of Lisbon'}, 'officialTitle': 'Study of an Essential Oil and a Delmopinol Mouthrinse Effect on Dental Plaque Accumulation Index, Gingivitis Index and on Streptococcus Mutans, Lactobacillus, Aerobic and Anaerobic Oral Bacteria Colony Counts.', 'orgStudyIdInfo': {'id': '9/2006a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Delmopinol mouthrinse', 'description': 'Subjects use the delmopinol mouthrinse', 'interventionNames': ['Drug: Delmopinol mouthrinse']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subjects with no use of mouthrinse'}, {'type': 'EXPERIMENTAL', 'label': 'Essential oils mouthrinse', 'description': 'Subjects using the essential oils mouthrinse', 'interventionNames': ['Drug: Essential oils mouthrinse']}], 'interventions': [{'name': 'Essential oils mouthrinse', 'type': 'DRUG', 'otherNames': ['Listerine Cool Mint'], 'description': "Commercial mouthrinse with manufacturer's use indication", 'armGroupLabels': ['Essential oils mouthrinse']}, {'name': 'Delmopinol mouthrinse', 'type': 'DRUG', 'otherNames': ['Decapinol'], 'description': "Commercial mouthrinse with manufacturer's use indication", 'armGroupLabels': ['Delmopinol mouthrinse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1649-003', 'city': 'Lisbon', 'state': 'Lisbon District', 'country': 'Portugal', 'facility': 'Faculdade de Medicina Dentária da Universidade de Lisboa', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'overallOfficials': [{'name': 'Mario F Bernardo, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculdade de Medicina Dentária da Universidade de Lisboa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lisbon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Piaget', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Henrique Soares Luis', 'oldOrganization': 'Faculdade de Medicina Dentária da Universidade de Lisboa'}}}}