Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-02-21 @ 8:17 AM
Study NCT ID:
NCT02929602
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2016-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Use and Effectiveness for Dental Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2773}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-07', 'studyFirstSubmitDate': '2016-02-05', 'studyFirstSubmitQcDate': '2016-10-07', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient questionnaire - side effects of analgesics post dental procedure', 'timeFrame': '5 days post dental procedure', 'description': '(Descriptive methods were used) to determine side effects: Yes/no, describe for Rx and OTC analgesic medications.'}], 'primaryOutcomes': [{'measure': 'Dentist questionnaire', 'timeFrame': 'baseline', 'description': "dentists' postprocedural prescriptions were recorded by analgesic class: Opioid, NSAID, or other (Descriptive measures)"}], 'secondaryOutcomes': [{'measure': 'Dentist questionnaire - anticipated pain by patients using VAS-5 pain scale', 'timeFrame': '5 days after the dental procedure', 'description': 'anticipated pain severity using the VAS-5 pain scale (1-5 scale)'}, {'measure': 'Patient questionnaire - OHIP-14 patient reported outcomes quality of life survey (questionnaire).', 'timeFrame': '5 days after the dental procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prescribing', 'effectiveness', 'dental', 'opioid', 'analgesic'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '27875056', 'type': 'DERIVED', 'citation': 'Wong YJ, Keenan J, Hudson K, Bryan H, Naftolin F, Thompson VP, Craig RG, Vena D, Collie D, Wu H, Matthews AG, Grill AC, Curro FA. Opioid, NSAID, and OTC Analgesic Medications for Dental Procedures: PEARL Network Findings. Compend Contin Educ Dent. 2016 Nov/Dec;37(10):710-718.'}]}, 'descriptionModule': {'briefSummary': 'Opioid analgesics prescribed by dentists may contribute to the larger national issue of the use and abuse of the drug. On occasion dental pain may be sufficiently severe to support the use of opioids. This study used both dentist and patient input to evaluate the use of opioid and over-the-counter analgesics following one of seven coded common dental procedures. The study includes a five day patient follow up assessment of the effectiveness of the analgesic. Baseline questionnaires were completed by eligible participants, and they responded to the day 5 follow up questionnaires.', 'detailedDescription': "Specific Aims The overall objective of the proposed study is to determine (1) the pattern of analgesic prescriptions (Rx and OTC) and recommendations (OTC) in dental practices; and (2) the effectiveness of and side effects associated with these medications as measured by patientreported outcomes (PROs).\n\nSpecific Aim 1: To document (a) dentists' postprocedural prescriptions and recommendations for analgesic medication: and (b) the effectiveness of these medications and side effects associated with their use as measured by PROs.\n\nSpecific Aim 2: To analyze by procedure class and anticipated pain severity the PROs of Rx and OTC analgesic medications.\n\nSpecific Aim 3: Determine the incidence of analgesic side effects of Rx and OTC analgesic medications.\n\nThe outcomes of Specific Aims 1-3 will be:\n\n* The distribution of dentists' Rx/OTC prescriptions/recommendations by dentists for anticipated pain severity.\n* The effectiveness of different types of Rx and OTC analgesics (e.g., Rx NSAIDs vs. OTC NSAIDs, Rx NSAIDs vs. Rx narcotics) by procedure class and anticipated pain severity.\n* The incidence of analgesic side effects for Rx and OTC analgesics. Analysis of the results and methods of the proposed research will furthermore serve as guidance in designing a randomized PBRN clinical trial comparing the efficacy of and complications associated with two or more analgesics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Practice-based study. Patients recruited from the practice sites of PEARL Network dentists.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Presence of erupted second molar teeth.\n2. Scheduled for treatment in one procedure of the following six procedure classes:\n\n extraction, endodontic therapy, pulp capping, crown preparation, periodontal surgery, abscess treatment\n3. Expected by the P-I to experience postoperative pain sufficient to require an analgesic\n4. Permanent dentition (erupted 2nd molar teeth)\n5. Capacity to judge pain level\n6. Ability and willingness to give verbal consent\n\nExclusion Criteria:\n\n1. Under treatment for medical disorders, including dementia, Parkinson's disease, depression, severe anxiety, or any other medical condition, that, in the opinion of the P-I, would affect the subject's judgment of postoperative pain\n2. Current participation in another dental or medical research study."}, 'identificationModule': {'nctId': 'NCT02929602', 'briefTitle': 'Analgesic Use and Effectiveness for Dental Procedures', 'organization': {'class': 'NETWORK', 'fullName': 'Pearl Network'}, 'officialTitle': 'PRL0706: Analgesic Use and Effectiveness', 'orgStudyIdInfo': {'id': 'PRL0706'}, 'secondaryIdInfos': [{'id': 'U01DE016755', 'link': 'https://reporter.nih.gov/quickSearch/U01DE016755', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'PEARL Network Sites', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Frederick A Curro, DMD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pearl Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Will send to the NIDCR.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pearl Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Institute of Dental and Craniofacial Research (NIDCR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}