Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-20 @ 11:22 PM
Study NCT ID:
NCT01409850
Status:
TERMINATED
Last Update Posted:
2014-12-03
First Post:
2011-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Study of Two Splints Used for Treatment of Acute Temporomandibular Pain.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-07-06', 'releaseDate': '2022-08-05'}], 'estimatedResultsFirstSubmitDate': '2022-08-05'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'whyStopped': 'Very slow enrollment of participants', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-02', 'studyFirstSubmitDate': '2011-08-03', 'studyFirstSubmitQcDate': '2011-08-03', 'lastUpdatePostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '2-3 weeks'}], 'secondaryOutcomes': [{'measure': 'mouth opening', 'timeFrame': '2-3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myofascial Pain']}, 'descriptionModule': {'briefSummary': 'The most commonly applied treatment against acute temporomandibular signs and symptoms is pharmacotherapy. The evidence on treatment efficacy of non-medication treatments (like splints) is very low. Two very commonly used splints are the Aqualizer® and the soft polyester splint. These are splints applied for a short period of time, until the treatment with a hard splint and/or physiotherapy begins. Aim of this study is to compare the clinical short-time efficacy of these two splints for the treatment of acute temporomandibular pain and compare it to a control group receiving no therapy for that short time.\n\nThe study hypothesis is that there is a difference in pain reduction between the three groups of patients (two intervention and one control group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, non-chronic orofacial pain\n\nExclusion Criteria:\n\n* Pregnancy, chronic orofacial pain, dental treatment need, dental pain, edentulous space larger than 5mm, more than three molars missing in the same quadrant, rheumatic disease, Injury/operation in maxillofacial area.'}, 'identificationModule': {'nctId': 'NCT01409850', 'briefTitle': 'Comparison Study of Two Splints Used for Treatment of Acute Temporomandibular Pain.', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Pilot Clinical Trial on the Treatment Effectiveness of Two Splints for Acute Temporomandibular Pain.', 'orgStudyIdInfo': {'id': 'UHeidelberg'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aqualizer', 'interventionNames': ['Device: Aqualizer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Soft splint', 'description': 'elastic splint made of copolyester foil', 'interventionNames': ['Device: Soft splint']}, {'type': 'NO_INTERVENTION', 'label': 'Counselling'}], 'interventions': [{'name': 'Aqualizer', 'type': 'DEVICE', 'description': 'The Aqualizer is a soft splint with water-filled pads.', 'armGroupLabels': ['Aqualizer']}, {'name': 'Soft splint', 'type': 'DEVICE', 'armGroupLabels': ['Soft splint']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Department of Prosthodontics, University Clinic of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.med.dent.,MSc', 'investigatorFullName': 'Giannakopoulos Nikolaos', 'investigatorAffiliation': 'Heidelberg University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-08-05', 'type': 'RELEASE'}, {'date': '2023-07-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Giannakopoulos Nikolaos, Dr.med.dent.,MSc, Heidelberg University'}}}}