Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-03 @ 8:05 PM
Study NCT ID:
NCT07101068
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This randomized, split-mouth clinical trial uses a computerized randomization system (Sealed Envelope) to allocate the two interventions: conventional anesthesia and Dental Anesthesia Injector. For each participant, one side of the mouth will receive local anesthesia via the Dental Anesthesia Injector, while the other side will receive the conventional anesthesia method. The randomization process ensures that the assignment of anesthesia methods to the right or left side is random for each participant. Allocation concealment is maintained by a third party who is not involved in data collection and manages the allocation assignments for each new participant'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-06-15', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain during injection', 'timeFrame': 'The pain felt by patient will be assessed by Visual analogue scale, Pulse rate and Oxygen saturation at day 1 of anesthesia injection.', 'description': 'The pain felt by patient will be assessed by Visual analogue scale which is a subjective scale {rating from 0 (no pain) to 10 (worst pain ) }\n\nPulse rate and oxygen saturation will be assessed also which are objective tools where the normal pulse rate is from 60 to 100 beats per minute, more than normal heart rate for the patient during injection and 1 minute after means anxiety The normal Oxygen saturation of the body is from 95% up to 100% the increase in the rating of the Oxygen saturation during the injection and 1 minute after injection means that the patient feels anxiety'}, {'measure': 'Anxiety felt by the patient', 'timeFrame': 'the scale will be used at day 1 of anesthesia injection', 'description': 'Anxiety felt by the patient during dental visit will be assessed using Corah Dental Anxiety Scale which is a subjective scale consist of brief questionnaire designed to measure anxiety related to dental visits, each question has 5 answers from a to e (a) answers give rating 1 that mean least anxiety felt and (e) answers give rating 5 that mean sever anxiety. If the total rating of the 4 questions \\<9 means that the patient has mild anxiety. If the total rating from 15 to 20 means that the patient has sever anxiety.'}], 'secondaryOutcomes': [{'measure': 'Need for additional anesthesia', 'timeFrame': 'The assessment will be done during dental visit at day 1 of anesthesia injection', 'description': 'Need for additional anesthesia will be assessed by the operator if the patient feels pain and we have to administer additional anesthesia with the same concentration and the same tool of injection for the second time to treat the same tooth at same dental visit.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric Dentistry', 'Local Anesthesia', 'Dental Anesthesia Injector', 'Conventional Syringe', 'Pain Assessment', 'Vasual Analogue Scale', 'Corah Dental Anxiety Scale', 'Pulse Oximeter', 'Split-mouth Design', 'Reversible Pulpitis'], 'conditions': ['Dental Caries', 'Reversible Pulpitis']}, 'referencesModule': {'references': [{'pmid': '36627224', 'type': 'BACKGROUND', 'citation': 'Vitale MC, Gallo S, Pascadopoli M, Alcozer R, Ciuffreda C, Scribante A. Local anesthesia with SleeperOne S4 computerized device vs traditional syringe and perceived pain in pediatric patients: a randomized clinical trial. J Clin Pediatr Dent. 2023 Jan;47(1):82-90. doi: 10.22514/jocpd.2023.002. Epub 2023 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial is conducted on pediatric dental patients to compare the effectiveness of local anesthesia administered using a dental anesthesia injector device versus the traditional syringe method. The study aims to assess and compare pain and anxiety levels associated with both methods, using both subjective (self-reported) and objective measures. The goal is to identify an alternative technique that minimizes pain and anxiety in pediatric dental patients.', 'detailedDescription': 'This randomized controlled split-mouth clinical trial aims to assess pain and anxiety in pediatric dental patients during and immediately after the administration of local anesthesia using a dental anesthesia injector device compared to a conventional syringe.\n\nThe study will include healthy, cooperative children aged 6 to 8 years, each having at least one vital deeply carious maxillary primary molar with signs and symptoms of reversible pulpitis on each side of the maxilla requiring buccal infiltration anesthesia prior to pulpotomy.\n\nEach child will receive both injection techniques on separate occasions, with random assignment of the injection method to either the right or left side (split-mouth design).\n\nTo evaluate pain and anxiety, the following tools will be used:\n\nPain: Visual Analogue Scale (VAS) Anxiety: Corah Dental Anxiety Scale Physiological measures: Heart rate and oxygen saturation levels, recorded using a pulse oximeter Data will be collected during and immediately after the injection. The aim is to determine whether the dental anesthesia injector provides a less painful and less anxiety-inducing experience compared to the traditional syringe method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* normal healthy patients (ASA I)\n* Undergoing the first dental local anesthesia experience\n* Presence of one at least vital deeply carious maxillary primary molar indicated for pulpotomy on each side of maxilla\n* Score 3 or 4 of Frankl scale of child behavior\n\nExclusion Criteria:\n\n* Presence of gingivitis, dental abscess, facial trauma/ injury\n* Administration of analgesic 48 h before randomization\n* Presence of allergy from local anesthesia'}, 'identificationModule': {'nctId': 'NCT07101068', 'briefTitle': 'Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'A Randomized Clinical Trial to Assess Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients', 'orgStudyIdInfo': {'id': 'FDSU-Rec IMO12441'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dental Anesthesia Injector', 'description': 'Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa.\n\nLocal anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia injector .', 'interventionNames': ['Device: Dental Anesthesia Injector']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional syringe', 'description': 'Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe', 'interventionNames': ['Other: conventional syringe']}], 'interventions': [{'name': 'Dental Anesthesia Injector', 'type': 'DEVICE', 'description': 'Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia Injector.', 'armGroupLabels': ['Dental Anesthesia Injector']}, {'name': 'conventional syringe', 'type': 'OTHER', 'description': 'Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe', 'armGroupLabels': ['Conventional syringe']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Postgraduate Studies, Ain Shams University', 'role': 'CONTACT', 'email': 'Dean@dent.asu.edu.org', 'phone': '0222639083', 'phoneExt': '20102300497'}, {'name': 'Samaa Abdo Mahmoud, Demonstrator', 'role': 'CONTACT', 'email': 'samaa.abdo@dent.bsu.edu.eg', 'phone': '201023004597'}, {'name': 'samaa Mohamed Abd El Saeed, Demonstrator', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Faculty of dentistry, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Samaa Abdo Mahmoud, Demonstrator', 'role': 'CONTACT', 'email': 'samaa.abdo@dent.asu.edu.eg', 'phone': '201023004597'}, {'name': 'Samaa Mahmoud Abd El Saeed, Demonstrator', 'role': 'CONTACT', 'email': 'samaaabdo95@gmail.com', 'phone': '201032291056'}], 'overallOfficials': [{'name': 'Sarah Mohamed Shafik, Associate Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pediatric Dentistry department, Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Faculty of Dentistry Ain Shams university Research Ethics Committee, state that data will not be shared to preserve the confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}