Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-01-01 @ 8:06 AM
Study NCT ID:
NCT06644703
Status:
COMPLETED
Last Update Posted:
2024-10-16
First Post:
2024-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cryotherapy on Postoperative Pain in Vital Pulp Treatment of Molar Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017679', 'term': 'Cryotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2024-10-01', 'studyFirstSubmitQcDate': '2024-10-15', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': 'up to 72 hours', 'description': 'The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cryotherapy', 'Vital pulp therapy', 'Irreversibl pulpitis', 'Postoperative pain', 'Total pulpotomy'], 'conditions': ['Pulpitis - Irreversible']}, 'referencesModule': {'references': [{'pmid': '38668793', 'type': 'BACKGROUND', 'citation': 'Akhil VS, Kumar V, Aravind A, Sharma R, Sharma S, Chawla A, Upadhyay AD, Logani A. Novel cryotherapy technique for pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis- a randomized controlled trial. Clin Oral Investig. 2024 Apr 26;28(5):275. doi: 10.1007/s00784-024-05661-y.'}, {'pmid': '27699913', 'type': 'BACKGROUND', 'citation': 'Keskin C, Ozdemir O, Uzun I, Guler B. Effect of intracanal cryotherapy on pain after single-visit root canal treatment. Aust Endod J. 2017 Aug;43(2):83-88. doi: 10.1111/aej.12175. Epub 2016 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial was to evaluate the effect of cryotherapy with salin solution on the intensity of postoperative pain after total pulpotomy procedures in molar teeth with symptomatic irreversible pulpitis. The main question it aims to answer is:\n\n\\- Does controlled irrigation with cold saline in total pulpotomy reduce the severity of postoperative pain? In the cryotherapy group, unlike the control group, after hemostasis was achieved, the coronal pulp cavity was irrigated with 2 °C saline solution for 5 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTeeth with\n\n* moderate or severe pain\n* diagnosed with symptomatic irreversible pulpitis\n* no tenderness to percussion and palpation\n* positive response to cold test and electric pulp test\n* no signs of periapical pathology\n\nExclusion Criteria:\n\nTeeth which\n\n* could not be restored or required post-core\n* had periapical lesions,\n* had poor periodontal status (pocket depth\\> 4 mm),\n* had negative responses to pulp sensitivity tests,\n* had no pulp exposure after caries removing Patients who\n* had no preoperative pain or had mild preoperative pain\n* had bleeding disorders\n* had systemic diseases such as immunosuppressive disease or diabetes'}, 'identificationModule': {'nctId': 'NCT06644703', 'briefTitle': 'Effect of Cryotherapy on Postoperative Pain in Vital Pulp Treatment of Molar Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'Effect of Cryotherapy on Postoperative Pain in Vital Pulp Treatment of Molar Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '10.05.2025/144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryotherapy group', 'description': 'After the coronal pulp tissue was completely removed up to the root canal orifice with a high-speed sterile diamond bur under water cooling, hemostasis was achieved within 8 minutes using a cotton pellet moistened with 1% NaOCl. The pulpotomy area was irrigated with 2 °C saline solution for 5 minutes. Then, the pulp chamber was covered with 2-3 mm thick Bio MTA+ (Cerkamed Company, Poland) and composite restoration of the teeth (Clearfil Majesty Posterior, Kuraray Medical Inc, Tokyo, Japan) was completed in the same visit.', 'interventionNames': ['Other: Cryotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'After the coronal pulp tissue was completely removed up to the root canal orifice with a high-speed sterile diamond bur under water cooling, hemostasis was achieved within 8 minutes using a cotton pellet moistened with 1% NaOCl. Then, the pulp chamber was covered with 2-3 mm thick Bio MTA+ (Cerkamed Company, Poland) and composite restoration of the teeth (Clearfil Majesty Posterior, Kuraray Medical Inc, Tokyo, Japan) was completed in the same visit.'}], 'interventions': [{'name': 'Cryotherapy', 'type': 'OTHER', 'description': 'The pulpotomy area was irrigated with 2 °C saline solution for 5 minutes in cryotherapy group.', 'armGroupLabels': ['Cryotherapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01250', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Çukurova Üniversitesi Diş Hekimliği Fakültesi, Gültepe, Sarıçam/Adana/Türkiye', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'overallOfficials': [{'name': 'Hamdi Oğuz Yoldaş, DDS PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cukurova University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cukurova University, Faculty of Dentistry', 'investigatorFullName': 'Kübra Gürler', 'investigatorAffiliation': 'Cukurova University'}}}}