Ignite Creation Date:
2025-12-17 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 12:32 AM
Study NCT ID:
NCT00762151
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2008-09-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-03', 'studyFirstSubmitDate': '2008-09-24', 'studyFirstSubmitQcDate': '2008-09-29', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing)', 'timeFrame': 'Baseline (time zero), 24 hour time point'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dental Plaque'], 'conditions': ['Dental Plaque']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to evaluate the anti-plaque efficacy of the Anacor prototype dentrifice as compared to commercial control products following a single use of the dentrifice.', 'detailedDescription': 'The widespread successful use of triclosan as an anti-inflammatory and anti-bacterial agent is well documented. The standard dentrifice has demonstrated a robust anti-plaque and anti-inflammatory effect providing multiple benefits. There is a clear value to identify additional agents with the same dual action with a comparable or an enhanced level of efficacy. This study examined the anti-plaque efficacy following a single use of the prototype dentifrice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be between ages 18 to 65 years inclusive\n* Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present\n* Must give written informed consent\n* Be in good general health\n* Must discontinue oral hygiene for 24-hours after initial appointment\n* No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study\n\nExclusion Criteria:\n\n* Medical condition which requires pre-medication prior to dental visits/procedures\n* Advanced periodontal disease\n* 5 or more decayed, untreated dental sites\n* Diseases of the soft or hard oral tissues\n* Orthodontic appliances\n* Abnormal salivary function\n* Use of drugs that can affect salivary flow\n* Use of antibiotics one (1) month prior to or during this study\n* Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxen), unless approved by the study medical staff\n* Pregnant or breastfeeding\n* Participation in another clinical study in the month preceding this study\n* Allergic to common dentifrice ingredients\n* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)\n* History of allergic reaction to any anti-inflammatory agents'}, 'identificationModule': {'nctId': 'NCT00762151', 'briefTitle': 'A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Clinical Research Study to Investigate the Anti-Plaque Effect of a Prototype Toothpaste Containing an Anacor Material Via the MGMPI Method', 'orgStudyIdInfo': {'id': 'AN0128 Periodontal Plaque'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Negative Control', 'description': 'Regular Toothpaste', 'interventionNames': ['Other: Negative Control (Regular Toothpaste)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Positive Control', 'description': 'Standard anti-plaque and anti-bacterial toothpaste.', 'interventionNames': ['Other: Positive Control (anti-plaque/anti-bacterial toothpaste)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prototype', 'description': 'AN0128 Toothpaste', 'interventionNames': ['Drug: Prototype (AN0128 Toothpaste)']}], 'interventions': [{'name': 'Negative Control (Regular Toothpaste)', 'type': 'OTHER', 'description': 'Regular Toothpaste', 'armGroupLabels': ['Negative Control']}, {'name': 'Positive Control (anti-plaque/anti-bacterial toothpaste)', 'type': 'OTHER', 'description': 'Standard anti-plaque and anti-bacterial toothpaste', 'armGroupLabels': ['Positive Control']}, {'name': 'Prototype (AN0128 Toothpaste)', 'type': 'DRUG', 'description': 'AN0128 Toothpaste', 'armGroupLabels': ['Prototype']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07927', 'city': 'Cedar Knolls', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Concordia Research Laboratories', 'geoPoint': {'lat': 40.82204, 'lon': -74.44876}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}