Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT04735120
Status:
UNKNOWN
Last Update Posted:
2021-02-04
First Post:
2021-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laser Activation in Reducing Pain During and After Root Canal Treatment for Painful Lower Molar Teeth.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2021-01-26', 'studyFirstSubmitQcDate': '2021-01-30', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in intraoperative pain measured using visual analog scale during root canal treatment following laser application', 'timeFrame': 'procedure (during root canal treatment)', 'description': 'Change in pain is assessed in 10 point visual analog scale (VAS) before and after laser application.'}], 'secondaryOutcomes': [{'measure': 'Change in postoperative pain measured using visual analog scale after root canal treatment', 'timeFrame': '48 hours', 'description': 'change in post-operative pain following laser application is assessed using 10 point visual analog scale (VAS) over phone call.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Decayed Teeth']}, 'descriptionModule': {'briefSummary': 'Effectiveness of lasers in reducing pain during and after root canal treatment for mandibular molar teeth affected with acute irreversible pulpitis.', 'detailedDescription': 'AIM : To assess the intraoperative and postoperative pain incidence for single visit root canal treatment for mandibular molar teeth with acute irreversible pulpitis following laser activation.\n\nMATERIALS AND METHODS: The study will account the patients who are referred to the Department of Endodontics,both male and female patients,with pain due to acute irreversible pulpitis from carious mandibular first and second molar teeth requiring root canal treatment. Subjects of age 13 to 70 years who met the inclusion criteria and responded positively to cold test will be included in the study.\n\nSingle visit root canal treatment with 2.5 mL of 2% lignocaine containing 1:80,000 adrenaline for an inferior alveolar block injection will be administered for each individual. After achieving anesthesia, patients who exhibit pain following access opening will be subjected to diode laser application on the pulp canal orifices. With regard to intraoperative pain, pre laser and post laser intraoperative pain incidence will be recorded. Once when the intraoperative pain incidence is reduced, patients will be reassessed for the need of additional anesthesia. If fully anesthetised, root canal procedure will be completed. Preoperative, intraoperative( before and laser application) pulse rate will also be measured. The levels of preoperative and post-operative pain at 24 hrs and 48 hrs for each patient will be recorded using a 10-point visual analog scale (VAS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with painful mandibular molar teeth due to caries with no history of medication intake before 7 days prior to root canal treatment\n* Patients who respond exaggerated pain with or without lingering response on cold test\n\nExclusion Criteria:\n\n* Patients who do not have pain upon access opening following local anesthesia administration\n* Teeth with poor periodontal or restorative prognosis,\n* Patients with serious systemic ailments or conditions hindering single visit root canal treatment\n* patients not willing to participate in the post operative recall evaluation\n* Teeth with anatomic variations and\n* Allergic patients are excluded'}, 'identificationModule': {'nctId': 'NCT04735120', 'briefTitle': 'Laser Activation in Reducing Pain During and After Root Canal Treatment for Painful Lower Molar Teeth.', 'organization': {'class': 'OTHER', 'fullName': 'CSI College of Dental Sciences and Research, Madurai'}, 'officialTitle': 'Effect of Laser Activation on the Intraoperative and Post-treatment Pain in Single Visit Root Canal Treatment for Mandibular Molar Teeth With Acute Irreversible Pulpitis', 'orgStudyIdInfo': {'id': 'CSICDSR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser to reduce pain intraoperatively and post operatively', 'description': 'Diode lasers are used to assess its efficacy in reducing intraoperative and postoperative pain following root canal treatment in mandibular molar teeth with acute irreversible pulpitis', 'interventionNames': ['Device: iLASE DIODE LASERS']}], 'interventions': [{'name': 'iLASE DIODE LASERS', 'type': 'DEVICE', 'description': '940nm diode laser with 1.5 watts activated in a continuous mode and applied on to the canal orifices during root canal treatment to reduce intraoperative pain and further its effect on post operative pain is assessed', 'armGroupLabels': ['Laser to reduce pain intraoperatively and post operatively']}]}, 'contactsLocationsModule': {'locations': [{'zip': '625001', 'city': 'Madurai', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'SUBASHRI VISWANATHAN, MDS III YEAR', 'role': 'CONTACT', 'email': 'shrimitha26@gmail.com', 'phone': '9445659453'}], 'facility': 'Csi College of Dental Sciences and Research', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSI College of Dental Sciences and Research, Madurai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Dr SUBASHRI V', 'investigatorAffiliation': 'CSI College of Dental Sciences and Research, Madurai'}}}}