Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT06268912
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2024-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cryoanalgesia for Irreversible Pulpitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2024-01-09', 'studyFirstSubmitQcDate': '2024-02-16', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Pain and Anxiety', 'timeFrame': '1 visit of 1 hour', 'description': 'Pain during injection, caries removal, access cavity, and instrumentation were recorded. The patients received a full description of the procedure, and patients were asked to rate their current pain and their anxiety with a descriptive scale (Heft-Parker Visual Analog Scale (VAS) before starting the treatment. A visual analog scale of 170 mm that the start points on the left side means "no pain" and the endpoint on the right side means "severe pain". The participants indicated their pain level by marking a point on the scale that best represented their experience. For data interpretation, the Visual Analog Scale (VAS) was segmented into four categories: no pain corresponded to 0 mm on the scale, mild pain as greater than 0 and ≤54mm, moderate pain defined as greater than 54 mm and less than 114 mm and severe pain defined as 114 mm or more.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cryoanalgesia', 'Irreversible Pulpitis', 'Pain Management'], 'conditions': ['Pulpitis - Irreversible']}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to evaluate the effectiveness of pulpal anesthesia in pain control during endodontic treatment by lowering the temperature of the injected plain 3% cold Mepivacaine (5ºC) compared to 3% Mepivacaine at room temperature in teeth with irreversible pulpitis.', 'detailedDescription': 'Mepivacaine has some advantages over other anesthetics. The investigators wanted to compare whether changing temperature could improve its effectiveness in cases of irreversible pulpitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll Patients within the age group of 18-100 years old,\n\n* Patients diagnosed of irreversible pulpitis.\n\nExclusion Criteria:\n\n* Moderate to pulp necrosis,\n* Previous initiated treatment.\n* Pregnancy or lactation.\n* Allergy or problems to any substances used in the study,\n* Acute apical abscess.\n* Chronic apical abscess.\n* Unrestorable teeth.\n* Unsuccessful anesthesia technique (no lip numbness for lower molars or positive response to cold test).'}, 'identificationModule': {'nctId': 'NCT06268912', 'acronym': 'CryPain', 'briefTitle': 'Cryoanalgesia for Irreversible Pulpitis', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Internacional de Catalunya'}, 'officialTitle': 'Cryoanalgesia: Temperature Modulation for Pain Management in Irreversible Pulpitis a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'END-ECL-2022-01'}, 'secondaryIdInfos': [{'id': 'END-ECL-2022-01', 'type': 'OTHER', 'domain': 'UIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cold Mepivacaine', 'description': 'Mepivacaine 3% at 5ºC', 'interventionNames': ['Procedure: Cold Mepivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mepivacaine at room temperature', 'description': 'Mepivacaine 3% at room temperature', 'interventionNames': ['Procedure: Mepivacaine at room temperature']}], 'interventions': [{'name': 'Cold Mepivacaine', 'type': 'PROCEDURE', 'description': 'change the temperature, 3% at 5ºC', 'armGroupLabels': ['Cold Mepivacaine']}, {'name': 'Mepivacaine at room temperature', 'type': 'PROCEDURE', 'description': 'no change the temperature of anesthesia', 'armGroupLabels': ['Mepivacaine at room temperature']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Gonzalo Gomez', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'gonzalo gomez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UIC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Internacional de Catalunya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Gonzalo Gómez Val', 'investigatorAffiliation': 'Universitat Internacional de Catalunya'}}}}