Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-01-05 @ 5:28 PM
Study NCT ID:
NCT03513692
Status:
UNKNOWN
Last Update Posted:
2019-04-16
First Post:
2018-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A RCT to Compare Post-operative Sensitivity of Restorations With Fill-Up, a Dual Curing Composite and Conventional Composite Resin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2018-04-18', 'studyFirstSubmitQcDate': '2018-04-30', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative sensitivity', 'timeFrame': '1 month', 'description': 'patient assessment by VAS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Sensitivity of Existing Dental Filling Materials']}, 'descriptionModule': {'briefSummary': "The trial compares patient-reported postoperative sensitivity of 2 existing dental filling materials. The dental filling materials will be used according to manufacturer's instructions and within the existing CE marked licence. We are interested in investigating which licensed material confers the least postoperative discomfort to our patients in normal clinical use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is over 18\n2. Patient is under 70\n3. Patient is capable of informed consent\n4. The tooth responds to sensitivity testing ('vitality test' with an electric pulp tester)\n5. The cavity is suitable for composite restoration\n6. The patient prefers composite to amalgam.\n7. The restoration required involves 2 or more surfaces of the tooth\n\nExclusion Criteria:\n\n1. The tooth does not respond to an electric pulp test\n2. The patient is suffering dental pain at the time of consent\n3. The patient is currently taking long term analgesics\n4. The patient is incapable of giving informed consent\n5. The patient is a child under 18\n6. The patient is unable to return the VAS assessment sheets at the appropriate time\n7. The tooth to be filled is periodontally involved (grade 2 or grade 3 mobile)"}, 'identificationModule': {'nctId': 'NCT03513692', 'briefTitle': 'A RCT to Compare Post-operative Sensitivity of Restorations With Fill-Up, a Dual Curing Composite and Conventional Composite Resin', 'organization': {'class': 'OTHER', 'fullName': 'University of Leeds'}, 'officialTitle': 'A Randomised Controlled Trial to Compare Post-operative Sensitivity of Restorations Completed With Fill-Up, a Dual Curing Composite and Conventional Composite Resin', 'orgStudyIdInfo': {'id': 'IRAS project ID: 213486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fill-Up composite resin', 'description': 'In this arm of the study, participants will have the dental restoration completed with "FillUp" from Coltene, a composite resin a CE marked and licensed restorative material.', 'interventionNames': ['Device: Fill-Up composite resin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional; composite', 'description': 'In this arm of the study, participants will have the dental restoration completed with a conventional composite resin using a CE marked and licensed restorative material.', 'interventionNames': ['Device: Fill-Up composite resin']}], 'interventions': [{'name': 'Fill-Up composite resin', 'type': 'DEVICE', 'otherNames': ['conventional composite resin'], 'description': '2 arm study comparing restoration of a tooth with either FillUp composite or conventional composite', 'armGroupLabels': ['Conventional; composite', 'Fill-Up composite resin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9LU', 'city': 'Leeds', 'state': 'Yorkshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'T P Hyde, PhD BChD', 'role': 'CONTACT', 'email': 't.p.hyde@leeds.ac.uk', 'phone': '+44 (0)1133438515'}, {'name': 'Nihad Vaid, BDS', 'role': 'CONTACT'}], 'facility': 'University of Leeds', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'centralContacts': [{'name': 'T P hyde, PhD BChD', 'role': 'CONTACT', 'email': 't.p.hyde@leeds.ac.uk', 'phone': '+44 (0)1133438515'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leeds', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'T Paul Hyde', 'investigatorAffiliation': 'University of Leeds'}}}}