Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT03919318
Status:
COMPLETED
Last Update Posted:
2019-12-03
First Post:
2019-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postoperative Pain After the Use of Different Root Canal Sealers
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-30', 'studyFirstSubmitDate': '2019-04-14', 'studyFirstSubmitQcDate': '2019-04-16', 'lastUpdatePostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 6th hours.', 'timeFrame': '6th hours', 'description': 'Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.'}, {'measure': 'Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 12th hours.', 'timeFrame': '12th hours', 'description': 'Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.'}, {'measure': 'Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 24th hours.', 'timeFrame': '24th hours', 'description': 'Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.'}, {'measure': 'Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 48th hours.', 'timeFrame': '48th hours', 'description': 'Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.'}, {'measure': 'Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 3rd days.', 'timeFrame': '3rd days', 'description': 'Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.'}, {'measure': 'Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 4th days.', 'timeFrame': '4th days', 'description': 'Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.'}, {'measure': 'Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 5th days.', 'timeFrame': '5th days', 'description': 'Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.'}, {'measure': 'Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 6th days.', 'timeFrame': '6th days', 'description': 'Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.'}, {'measure': 'Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 7th days.', 'timeFrame': '7th days', 'description': 'Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.'}], 'secondaryOutcomes': [{'measure': 'Analgesic intake comparison after root canal obturation with three different endodontic sealers at 6th hours.', 'timeFrame': '6th hours', 'description': 'The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"'}, {'measure': 'Analgesic intake comparison after root canal obturation with three different endodontic sealers at 12th hours.', 'timeFrame': '12th hours', 'description': 'The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"'}, {'measure': 'Analgesic intake comparison after root canal obturation with three different endodontic sealers at 24th hours.', 'timeFrame': '24th hours', 'description': 'The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"'}, {'measure': 'Analgesic intake comparison after root canal obturation with three different endodontic sealers at 48th hours.', 'timeFrame': '48th hours', 'description': 'The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"'}, {'measure': 'Analgesic intake comparison after root canal obturation with three different endodontic sealers at 3rd days.', 'timeFrame': '3rd days', 'description': 'The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"'}, {'measure': 'Analgesic intake comparison after root canal obturation with three different endodontic sealers at 4th days.', 'timeFrame': '4th days', 'description': 'The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"'}, {'measure': 'Analgesic intake comparison after root canal obturation with three different endodontic sealers at 5th days.', 'timeFrame': '5th days', 'description': 'The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"'}, {'measure': 'Analgesic intake comparison after root canal obturation with three different endodontic sealers at 6th days.', 'timeFrame': '6th days', 'description': 'The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"'}, {'measure': 'Analgesic intake comparison after root canal obturation with three different endodontic sealers at 7th days.', 'timeFrame': '7th days', 'description': 'The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative pain', 'Endoseal MTA', 'Endosequence BC', 'AH Plus', 'Root canal filling', 'endodontic treatment'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '29571915', 'type': 'BACKGROUND', 'citation': 'Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20.'}, {'pmid': '30397735', 'type': 'BACKGROUND', 'citation': 'Atav Ates A, Dumani A, Yoldas O, Unal I. Post-obturation pain following the use of carrier-based system with AH Plus or iRoot SP sealers: a randomized controlled clinical trial. Clin Oral Investig. 2019 Jul;23(7):3053-3061. doi: 10.1007/s00784-018-2721-6. Epub 2018 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated the postoperative pain after the endodontic treatment using AH Plus, Endoseal MTA and EndoSequence BC sealers in root canal obturation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants between 18 - 60 years of age,\n* Good oral hygiene,\n* Have not taken any analgesics in the last day,\n* Have not taken antibiotics in the last week,\n* Patients diagnosed with asymptomatic irreversible pulpitis caused by deep carious lesion on the mandibular first or second molar teeth.\n* A prolonged positive response to cold vitality tests,\n* The presence of pulp, which is exposed during caries removing and bleeding with a dense and thick consistency.\n* The periapical region was healthy in radiographic diagnosis.\n\nExclusion Criteria:\n\n* Devital teeth that have no response to pulp test,\n* The presence of advanced periodontal disease,\n* Having a systemic disease that requires antibiotic prophylaxis,\n* Radiographically more than 30° root inclination, presence of clear apex, presence of calcification, presence of root resorption,\n* The need for root canal treatment which is mesial and/or distal neighbour of the tooth to be treated,\n* The presence of a sinus tract in the relevant tooth region,\n* Having systemic diseases that reduce immune system resistance,\n* Participants with allergic sensitivity to materials and agents that should be used during the root canal treatment,\n* Allergic sensitivity to local anesthetics,\n* Pregnant participants or participants in the lactation period,\n* Over preparation or over filling during treatment,\n* Teeth which cannot be applied a rubber-dam,\n* Teeth which was damaged enough to require coronal fiber post application,\n* Sensitive to Ibuprofen based analgesics.'}, 'identificationModule': {'nctId': 'NCT03919318', 'briefTitle': 'Postoperative Pain After the Use of Different Root Canal Sealers', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Effect of Two Different Calcium Silicate Based and One Epoxy Resin-based Root Canal Sealers on Postoperative Pain After Root Canal Treatments', 'orgStudyIdInfo': {'id': '2018/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AH-Plus', 'interventionNames': ['Other: Root Canal Filling Sealers']}, {'type': 'EXPERIMENTAL', 'label': 'EndoSeal MTA', 'interventionNames': ['Other: Root Canal Filling Sealers']}, {'type': 'EXPERIMENTAL', 'label': 'Endosequence BC Sealer', 'interventionNames': ['Other: Root Canal Filling Sealers']}], 'interventions': [{'name': 'Root Canal Filling Sealers', 'type': 'OTHER', 'description': 'Root Canal Obturation', 'armGroupLabels': ['AH-Plus', 'EndoSeal MTA', 'Endosequence BC Sealer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'state': 'İç Anadolu', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University, Faculty of Dentistry', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'Tuğrul Aslan, PHD. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Erciyes University, Faculty of Dentistry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant Prof.', 'investigatorFullName': 'Tuğrul Aslan', 'investigatorAffiliation': 'TC Erciyes University'}}}}