Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT04947267
Status:
COMPLETED
Last Update Posted:
2021-07-01
First Post:
2021-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Compare the Pulpal Oxygen Saturation Level After Administering Mepivacaine With and Without Vasoconstrictor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008619', 'term': 'Mepivacaine'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '2 % MEPIVACAINE WITH 1:100,000 EPINEPHRINE AND 3% MEPIVACAINE BOTH WERE MASKED BY DENTAL ASSISTANT WITH PINK AND BLUE COLOR RESPECTIVELY.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-23', 'studyFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2021-06-23', 'lastUpdatePostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PULPAL OXYGEN SATURATION', 'timeFrame': '60 minutes', 'description': 'Pulpal oxygen saturation levels were recorded for 60 min after administration of local anesthesia using Nellcor-PM10N pulse oximeter and Nellcor D-YS Multisite reusable sensor.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulpal oxygen saturation'], 'conditions': ['LOCAL ANESTHESIA']}, 'descriptionModule': {'briefSummary': 'As vasoconstrictors adversely affect pulpal hemodynamics, this study compared the pulpal oxygen saturation levels after employing inferior alveolar nerve block with 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) and 3% mepivacaine (3% Scandonest Plain).Two groups were made with 30 patients in each group. 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) was administered to the patients in Group A whereas 3% mepivacaine (3% Scandonest Plain) was administered to the patients in Group B. Rubber dam application, cavity preparation and composite filling was then done on the selected carious mandibular premolar. Pulpal oxygen saturation levels were recorded after administration of local anesthesia with Nellcor-550 pulse oximeter and Nellcor D-YS Multisite reusable sensor.', 'detailedDescription': "BACKGROUND ' Local anesthesia is the foremost requirement of an efficient operative dental procedure to be executed in a pain free and calm environment. Local anesthesia is available in two forms: with vasoconstrictor and without vasoconstrictor. As vasoconstrictors adversely affect pulpal hemodynamics, this study aims to compare the pulpal oxygen saturation levels after employing inferior alveolar nerve block with 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) and 3% mepivacaine (3% Scandonest Plain).\n\nNULL HYPOTHESIS There is no difference between the pulpal oxygen saturation levels after administering 2% mepivacaine with 1:100,000 epinephrine and 3% mepivacaine.\n\nALTERNATE HYPOTHESIS There is a difference between the pulpal oxygen saturation levels after administering 2% mepivacaine with 1:100,000 epinephrine and 3% mepivacaine.\n\nMETHOD Two groups were made with 30 patients in each group. 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) was administered to the patients in Group A whereas 3% mepivacaine (3% Scandonest Plain) was administered to the patients in Group B. Rubber dam application, cavity preparation and composite filling was then done on the selected carious mandibular premolar. Pulpal oxygen saturation levels were recorded after administration of local anesthesia with the Nellcor- PM 10N pulse oximeter and Nellcor D-YS Multisite reusable sensor.\n\nSTATISTICAL ANALYSIS The statistical package for social sciences version 21.0 is used for statistical analysis. Mean and standard deviation of the pulpal oxygen saturation levels for filled and unfilled teeth under the effect of 2% mepivacaine with 1:100,000 epinephrine and 3% mepivacaine were recorded. Mixed Way ANOVA will be applied to discern if there is any difference in the pulpal oxygen saturation levels within and between the two groups. Post Hoc Tuckey was applied to identify whether the paired difference is present within groups or between the two groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical status: healthy individuals with no current and past medical findings.\n* Medications: no current medications.\n* Both mature vital ipsilateral mandibular premolars:\n\n * Healthy premolar (ICDAS code 0)\n * Carious premolar (ICDAS code 4-6).\n* Periapical status\n\n * Healthy premolar - Periapical Index. (Code 1).\n * Carious premolar - Periapical Index. (Code 1).\n* Periodontal status\n\n * Healthy premolar - Classification of periodontal diseases and conditions (Code 0).\n * Carious premolar - Classification of periodontal diseases and conditions (Code 0).\n\nExclusion Criteria:\n\n* Patients with oral and maxillofacial syndromes and anomalies.\n* Pregnant and nursing mothers.\n* Class V carious lesions (sensor of pulse oximeter was placed on intact buccal, lingual and cervical surfaces).\n* Teeth with extracoronal restorations.\n* Teeth with developmental defects and other anomalies.\n* Dental trauma.\n* Teeth with symptoms of irreversible pulpitis.'}, 'identificationModule': {'nctId': 'NCT04947267', 'briefTitle': 'To Compare the Pulpal Oxygen Saturation Level After Administering Mepivacaine With and Without Vasoconstrictor', 'organization': {'class': 'OTHER', 'fullName': 'Dow University of Health Sciences'}, 'officialTitle': 'To Compare the Pulpal Oxygen Saturation Level After Administering Mepivacaine With and Without Vasoconstrictor: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'AAAli'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3% mepivacaine', 'description': '3% mepivacaine was administered via inferior alveolar nerve block.', 'interventionNames': ['Drug: 3% Mepivacaine Hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2% mepivacaine with 1:100,000 epinephrine', 'description': '2% mepivacaine with 1:100,000 epinephrine was administered via inferior alveolar nerve block.', 'interventionNames': ['Drug: 2% Mepivacaine with 1:100,000 epinephrine']}], 'interventions': [{'name': '3% Mepivacaine Hydrochloride', 'type': 'DRUG', 'otherNames': ['3% scandonest plain'], 'description': '1.8 ml of 3% mepivacaine (3% Scandonest, Septodont) was administered to Group B patients. Inferior alveolar nerve block was administered to both the groups. Rubber dam was then placed in the desired quadrant. Selected carious mandibular was restored and seven pulpal oxygen saturation spot readings were taken for an hour.', 'armGroupLabels': ['3% mepivacaine']}, {'name': '2% Mepivacaine with 1:100,000 epinephrine', 'type': 'DRUG', 'otherNames': ['2% scandonest special'], 'description': '1.8 ml of 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special, Septodont) was administered to Group A patients. Inferior alveolar nerve block was administered to both the groups. Rubber dam was then placed in the desired quadrant. Selected carious mandibular was restored and seven pulpal oxygen saturation spot readings were taken for an hour.', 'armGroupLabels': ['2% mepivacaine with 1:100,000 epinephrine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Dow University of Health Sciences', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'AFSHAN AMJAD ALI, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dow University of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Afshan Amjad Ali', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Afshan Amjad Ali', 'investigatorAffiliation': 'Dow University of Health Sciences'}}}}