Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT04303234
Status:
UNKNOWN
Last Update Posted:
2020-03-11
First Post:
2020-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assess Intraoperative Pain for Restorative Treatment of Maxillary 1st Permanent Molars Using Artinibsa Versus Artpharma in Children During Infiltration Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'single ( participant ) because the two interventions used in this trial are easily recognized by the investigator but the participant and the statistician will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-10', 'studyFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative Pain: Wong Baker rating scale', 'timeFrame': 'During the procedure.', 'description': 'Measuring by using Wong Baker rating scale the measuring unite is :Scale (0-10) including six faces.'}], 'secondaryOutcomes': [{'measure': 'Onset of anesthesia', 'timeFrame': 'Immediately after the injection.', 'description': 'is measuring by using stop watch and the unite is minutes. the unit is : minutes'}, {'measure': 'The sensation after injection', 'timeFrame': 'Immediately after the injection.', 'description': 'Evaluating the effect of the anesthesia by checking mucosa using the probe and measuring unite is binary (Yes or No)'}, {'measure': 'Time of numbness disappear', 'timeFrame': '2 hours postoperatively after the procedure.', 'description': 'Time of disappearance of numbness sensation by asking the parent/child and measuring is binary (Yes or No).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Articaine', 'Infiltration technique', 'Restoration primary teeth', 'Intraoperative pain'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess Intraoperative pain for restorative treatment of Maxillary First Permanent Molars using Artinibsa Versus Artpharma in children during infiltration technique.', 'detailedDescription': "Local anesthesia is very important during dental procedure because it's a temporary loss of sensation which will lead to decrease the pain. Local anesthesia started with discovery of Cocaine in 1860. Followed by developments of Novocaine 1904 and lignocaine in 1942 by Lofgren. It became the gold standard drug compared to other local anesthetic. Later, several new drugs were discovered such as:Bupivacaine, Articaine, Mepivicaine etc. Articaine Hydrochloride (HCL) was available in Germany since 1976. It's the only amide local anesthesia containing ester group in its molecular structure leading to metabolizing of the drug by both plasma esterases and liver microsomal enzymes, the clinical efficacy and advantages of articaine is the duration of its anesthetic effect and its superior diffusion through the bony tissue."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '8 Years', 'genderBased': True, 'genderDescription': '8-10 years old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 8-10 years old\n* Mentally capable of communication\n* Cooperative children need restorative treatment\n\nExclusion Criteria:\n\n* Medically compromised patient\n* Primary teeth requiring pulpotomy or pulpectomy\n* Parent or guardians who refuse participating in the study'}, 'identificationModule': {'nctId': 'NCT04303234', 'briefTitle': 'Assess Intraoperative Pain for Restorative Treatment of Maxillary 1st Permanent Molars Using Artinibsa Versus Artpharma in Children During Infiltration Technique', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Intraoperative Pain During Restorative Treatment Of Maxillary First Permanent Molars Using Artinibsa Versus Artpharma In Children After Infiltration Technique: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CEBD-CU-2020-03-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Artinibsa', 'description': 'Powerful local anesthetic with short time for patients who can not tolerate normal doses of vasoconstrictor latency.\n\nHigh lipid solubility gives a better diffusion through the soft tissue and bone being very effective in infiltrative techniques.\n\nDuration:\n\nLatency time: 2 minutes\n\nEach mL contains:\n\n4%Articaine 1:100000. Hydrochloride 40.00 mg, Epinephrine (D.C.I) 0.005 mg tartrate', 'interventionNames': ['Other: Artinibsa']}, {'type': 'EXPERIMENTAL', 'label': 'Artpharma', 'description': 'Its a special amide local anesthetic contain 4% articaine with epinephrine 1/200000 as a vasoconstrictor ,Contains only sulfite as a stabilizer (max 0.31 mg)', 'interventionNames': ['Other: Artpharma']}], 'interventions': [{'name': 'Artinibsa', 'type': 'OTHER', 'description': 'local anaesthetic solution with a short latency time. Its high lipid solubility gives it better diffusion through soft tissues and bone and makes it highly effective for infiltrative techniques.Each ml contains 4%Articaine 1:100000.', 'armGroupLabels': ['Artinibsa']}, {'name': 'Artpharma', 'type': 'OTHER', 'description': 'Its a special amide local anesthetic contain 4% articaine with epinephrine 1/200000 as a vasoconstrictor ,Contains only sulfite as a stabilizer (max 0.31 mg)', 'armGroupLabels': ['Artpharma']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amani ALAidaros, Master', 'role': 'CONTACT', 'email': 'amani.alaidaroos@dentistry.cu.edu.eg', 'phone': '01004358665'}, {'name': 'Fatma Korany Ismail, Phd', 'role': 'CONTACT', 'email': 'fatmadent@hotmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Amani Hamed Hashem AL-Aidaros', 'investigatorAffiliation': 'Cairo University'}}}}