Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-02 @ 8:47 AM
Study NCT ID:
NCT03261869
Status:
COMPLETED
Last Update Posted:
2017-08-25
First Post:
2017-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EFFICACY OF ICE PACK THERAPY AFTER IMPACTED THIRD MOLAR SURGERY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D014313', 'term': 'Trismus'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013035', 'term': 'Spasm'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-23', 'studyFirstSubmitDate': '2017-08-23', 'studyFirstSubmitQcDate': '2017-08-23', 'lastUpdatePostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative Visual Analogue Scale Scores', 'timeFrame': 'pre-operative-postoperative 7th day'}, {'measure': 'Post operative facial swelling', 'timeFrame': 'pre-operative-postoperative 7th day'}, {'measure': 'Post-operative mouth opening', 'timeFrame': 'pre-operative-postoperative 7th day'}], 'secondaryOutcomes': [{'measure': 'Complications after impacted third molar removal', 'timeFrame': 'pre-operative-postoperative 7th day'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ice pack therapy, third molar surgery, swelling, pain, trismus'], 'conditions': ['Impacted Third Molar Tooth']}, 'descriptionModule': {'briefSummary': 'this study evaluates the effect of cold application after impacted third molar extractions. Patients have bilateral impacted third molar tooth included in this study. Patients do not applied cold after extraction of third molar on one side and applied cold cold after extraction of third molar on the other side.', 'detailedDescription': 'Extraction of impacted teeth causes a trauma which results in an inflammatory response. Some postoperative symptoms may occur such as edema, pain, limitations in mouth opening and dysfunction as a consequence of the wisdom tooth extraction surgery.\n\nLocal cold application reduces the magnitude of postoperative symptoms. The physiological effects of cold application are as follows: vasoconstriction of blood vessels, blood flow to the region decreases, edema and inflammation decreases, slowdown in cell metabolism and a decrease in local oxygen demand due to the vasoconstriction effect of the cold. Cold therapy also induces muscle constriction which reduces muscle stress, pain and inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral bony mandibular third molar impactions\n* Has no systemic disease\n\nExclusion Criteria:\n\n* Different Pell-Gregory classification of impacted teeth\n* Previous or current gastric ulcer\n* Allergies or hypersensitivities to any common medications\n* pregnant or breastfeeding patients'}, 'identificationModule': {'nctId': 'NCT03261869', 'briefTitle': 'EFFICACY OF ICE PACK THERAPY AFTER IMPACTED THIRD MOLAR SURGERY', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'officialTitle': 'EFFICACY OF ICE PACK THERAPY AFTER IMPACTED THIRD MOLAR SURGERY: A RANDOMIZED CONTROLLED CLINICAL TRIAL', 'orgStudyIdInfo': {'id': 'D-KA 15/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cold application', 'description': 'Cold applied after extraction of third molar tooth.', 'interventionNames': ['Other: Cold application']}, {'type': 'NO_INTERVENTION', 'label': 'No Cold application', 'description': 'Cold application is not advised after extraction of third molar tooth'}], 'interventions': [{'name': 'Cold application', 'type': 'OTHER', 'armGroupLabels': ['Cold application']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant at deparment of oral and maxillofacial surgery', 'investigatorFullName': 'Nurettin Diker', 'investigatorAffiliation': 'Baskent University'}}}}