Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-28 @ 10:25 PM
Study NCT ID:
NCT00765167
Status:
COMPLETED
Last Update Posted:
2008-10-03
First Post:
2008-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Training and Calibration of Dental Examiners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005459', 'term': 'Fluorides'}, {'id': 'D014260', 'term': 'Triclosan'}, {'id': 'C010882', 'term': 'chlorhexidine gluconate'}], 'ancestors': [{'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-02', 'studyFirstSubmitDate': '2008-09-23', 'studyFirstSubmitQcDate': '2008-09-30', 'lastUpdatePostDateStruct': {'date': '2008-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dental plaque', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dental Plaque']}, 'descriptionModule': {'briefSummary': 'Training and calibration of dental examiners'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female volunteers 18-65 years of age\n* Good general health\n* Must sign informed consent form\n* Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.\n* No 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\n1. Subjects unable or unwilling to sign the informed consent form.\n2. Medical condition which requires pre-medication prior to dental visits/procedures\n3. Moderate or advanced periodontal disease or heavy dental tartar (calculus).\n4. 2 or more decayed untreated dental sites at screening.\n5. Other disease of the hard or soft oral tissues.\n6. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).\n7. Use of medications that can affect salivary flow (e.g. anticholinergics, adrenergics, antihistamines, vasoconstrictors or decongestants).\n8. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.\n9. Pregnant or nursing women.\n10. Participation in any other clinical study within 1 week prior to enrollment into this study.\n11. Allergy to chlorhexidine\n12. Use of tobacco products\n13. Subjects who must receive dental treatment during the study dates.\n14. Current use of Antibiotics for any purpose.\n15. Presence of an orthodontic appliance.\n16. History of allergy to common dentifrice ingredients.\n17. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)"}, 'identificationModule': {'nctId': 'NCT00765167', 'briefTitle': 'Training and Calibration of Dental Examiners', 'organization': {'class': 'INDUSTRY', 'fullName': 'Colgate Palmolive'}, 'officialTitle': 'Training and Calibration of Dental Examiners', 'orgStudyIdInfo': {'id': 'ATO-2007-PLA-01-RR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: Fluoride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: Triclosan', 'Drug: Fluoride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C', 'interventionNames': ['Drug: Chlorhexidine gluconate']}], 'interventions': [{'name': 'Fluoride', 'type': 'DRUG', 'description': 'Brush half mouth twice daily for four days', 'armGroupLabels': ['A']}, {'name': 'Triclosan', 'type': 'DRUG', 'description': 'Brush half mouth daily for four days', 'armGroupLabels': ['B']}, {'name': 'Chlorhexidine gluconate', 'type': 'DRUG', 'description': 'Mouth rinsing with 15 ml for 30 seconds twice a day for four days', 'armGroupLabels': ['C']}, {'name': 'Fluoride', 'type': 'DRUG', 'description': 'Brush half mouth daily for four days', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07101', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'UMDNJ Dental School', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}], 'overallOfficials': [{'name': 'Michael Deasy, DDS', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colgate Palmolive', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'William DeVizio/VP - Clinical Research', 'oldOrganization': 'Colgate Palmolive'}}}}