Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-04 @ 12:57 PM
Study NCT ID:
NCT00187850
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2005-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The CAP-2 Trial: Effect of Direct Pulp Capping Versus Partial Pulpotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003789', 'term': 'Dental Pulp Exposure'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-14', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The survival of the tooth with vital pulp and without apical radiolucency. The x-ray evaluation and the clinical sensibility test are carried out by a blinded observer.', 'timeFrame': '1 year after inclusion in the CAP-2'}], 'secondaryOutcomes': [{'measure': 'Gain of pain relief', 'timeFrame': 'after 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pulp capping', 'partial pulpotomy', 'Exposure of the pulp'], 'conditions': ['Dental Pulp Exposure']}, 'referencesModule': {'references': [{'pmid': '20572864', 'type': 'BACKGROUND', 'citation': 'Bjorndal L, Reit C, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Thordrup M, Dige I, Nyvad B, Fransson H, Lager A, Ericson D, Petersson K, Olsson J, Santimano EM, Wennstrom A, Winkel P, Gluud C. Treatment of deep caries lesions in adults: randomized clinical trials comparing stepwise vs. direct complete excavation, and direct pulp capping vs. partial pulpotomy. Eur J Oral Sci. 2010 Jun;118(3):290-7. doi: 10.1111/j.1600-0722.2010.00731.x.'}, {'pmid': '28410008', 'type': 'DERIVED', 'citation': 'Bjorndal L, Fransson H, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Hedenbjork-Lager A, Dige I, Thordrup M. Randomized Clinical Trials on Deep Carious Lesions: 5-Year Follow-up. J Dent Res. 2017 Jul;96(7):747-753. doi: 10.1177/0022034517702620. Epub 2017 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'CAP-2 Trial\n\nBackground: This trial is being done in conjunction with an ongoing clinical trial investigating stepwise excavation versus final excavation on deep caries lesions (The CAP-1 trial). The investigators lack systematic knowledge concerning the treatment of the exposed pulp and whether the capping of a pulp represents the same outcome as the partial removal of an additional 1-1.5 mm of the pulp tissue (partial pulpotomy).\n\nAim: The aim of the CAP-2 trial is in a randomised clinical trial to investigate the effect of direct pulp capping versus partial pulpotomy in patients who, from the beginning, have received either a final excavation or a stepwise excavation and where this intervention has led to the exposure of a vital pulp and/or the patient has not gained relief from tooth pain after excavation and placement of a temporary restoration.\n\nPatients: Patients include consecutive patients with deep caries who have been participating in the CAP-1 trial, where the pulp exposure to a bleeding pulp is present and/or pain relief has not been obtained.\n\nDesign: The CAP-2 trial is a randomised patient- and observer-blinded multicenter trial, with two parallel intervention groups. Patients who fulfill the inclusion criteria will be centrally bloc-randomised in the Copenhagen Trial Unit, Copenhagen DK, and stratified by age and pain. The allocation ratio is 1:1.\n\nThe Interventions and Products: Patients are allocated for direct pulp capping or partial pulpotomy. The patients will not be informed about the results of the randomisation, i.e. the type of intervention. In both groups the patient receives a calcium hydroxide seal covering the exposure and a glass ionomer restoration. The final resin restoration is placed following 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons participating in the CAP-1 trial, who have received a pulp exposure due to treatment or due to absence of pain relief.\n\nExclusion Criteria:\n\n* The CAP-1-treated tooth has ongoing unbearable pain and/or disturbed night sleep.\n* Visible pus from the pulp.'}, 'identificationModule': {'nctId': 'NCT00187850', 'briefTitle': 'The CAP-2 Trial: Effect of Direct Pulp Capping Versus Partial Pulpotomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'The CAP-2 Trial: Effect of Direct Pulp Capping Versus Partial Pulpotomy on CAP-1 Patients: A Randomised, Patient - and Observer-Blinded Multicenter Trial', 'orgStudyIdInfo': {'id': '10002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PP', 'description': 'Partial pulpotomy', 'interventionNames': ['Procedure: PP']}, {'type': 'OTHER', 'label': 'DPC', 'description': 'Direct pulp capping', 'interventionNames': ['Procedure: DPC']}], 'interventions': [{'name': 'PP', 'type': 'PROCEDURE', 'otherNames': ['cvek´s pulpotomy'], 'description': 'Partial pulpotomy', 'armGroupLabels': ['PP']}, {'name': 'DPC', 'type': 'PROCEDURE', 'description': 'Direct pulp capping', 'armGroupLabels': ['DPC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'state': 'Copenhagen N', 'country': 'Denmark', 'facility': 'Copenhagen University', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Lars Bjørndal, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health Insurance foundation', 'class': 'UNKNOWN'}, {'name': 'Dan Dental A/S', 'class': 'INDUSTRY'}, {'name': 'University of Aarhus', 'class': 'OTHER'}, {'name': 'Göteborg University', 'class': 'OTHER'}, {'name': 'Huddinge Faculty,Stockholm,Sweden', 'class': 'UNKNOWN'}, {'name': 'Uppsala FolkTandvård,Sweden', 'class': 'OTHER'}, {'name': 'Malmö Dental school,Sweden', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Dr.Odont', 'investigatorFullName': 'Lars Bjørndal', 'investigatorAffiliation': 'University of Copenhagen'}}}}