Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT07156032
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Starpen Injection Device Versus Conventional Syringe During Anesthesia and Extraction of Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective pain during injection', 'timeFrame': 'during procedure', 'description': 'Subjective pain perception during injection of infiltration anesthesia using Wong Baker Scale which represents a series of faces from 0-value happy face that represents lack of pain to a 10-value crying face which represents the worst possible face . On this basis , the patient chooses the face that best describes his/her level of pain.'}], 'secondaryOutcomes': [{'measure': 'Objective pain during infiltration', 'timeFrame': 'during procedure', 'description': 'Objective pain perception during infiltration anesthesia using Faces, legs, Arms, Crying, Consolability (FLACC) scale . The scale is scored in a range of 0-10 with 0 representing no pain. The observation lasts for 2-5 minutes. Each parameter is evaluated on a scale from 0 to 2; the total score is interpreted as follows: 0 = relaxed and comfortable, 1-3=mild, 4-6=moderate pain, 7-10=severe discomfort/ pain.'}, {'measure': 'Subjective pain during extraction', 'timeFrame': 'during procedure', 'description': 'Subjective pain perception during extraction of maxillary primary molars using Wong Baker Scale which represents a series of faces from 0-value happy face that represents lack of pain to a 10-value crying face which represents the worst possible face . On this basis , the patient chooses the face that best describes his/her level of pain.'}, {'measure': 'Objective pain during extraction', 'timeFrame': 'during procedure', 'description': 'Objective pain perception during extraction of maxillary primary molars using Faces, legs, Arms, Crying, Consolability (FLACC) scale . The scale is scored in a range of 0-10 with 0 representing no pain. The observation lasts for 2-5 minutes. Each parameter is evaluated on a scale from 0 to 2; the total score is interpreted as follows: 0 = relaxed and comfortable, 1-3=mild, 4-6=moderate pain, 7-10=severe discomfort/ pain.'}, {'measure': 'Physiological parameters ( heart rate )', 'timeFrame': 'Readings will be taken before and during anesthesia injection and during extraction.', 'description': "Physiological parameters ( heart rate) at three time points : baseline , during injection and during extraction using pulse oximeter on the child's index finger. At which 70-100 bpm is the normal range at rest and higher heart rate readings reflects anxiety/pain/ discomfort ."}, {'measure': 'Physiological parameter ( oxygen saturation)', 'timeFrame': 'Readings will be taken before and during anesthesia injection and during extraction.', 'description': "Physiological parameter ( oxygen saturation) at three time points : baseline , during injection and during extraction using pulse oximeter on the child's index finger. At which 95-100% is the normal range on room air . A drop below 94% indicates hypoxemia and immediate assessment must be for airway and breathing."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Starpen device', 'Computer controlled automatic injection device', 'Computer controlled injection', 'pain perception', 'infiltration anesthesia', 'extraction of maxillary primary molars'], 'conditions': ['Pain Perception of the New Device']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of Starpen device on pain perception during anesthesia and extraction of maxillary primary molars.', 'detailedDescription': 'After enrollment of the patients according to the eligibility criteria, taking full medical , dental history and informed consents from the parents. Clinical and radiographic examination will be done for the tooth to be extracted. A diagnostic chart with personal, medical and dental history will be filled out . Also preoperative psychological management of the child through positive reinforcement techniques should be done . Then the two parallel groups will have local anesthesia using an infiltration technique in the upper jaw ; one group with conventional syringe and the other group by Starpen automatic injection device . Both groups will have the site of injection well prepared before injection by the same way and technique. In Addition, procedures as anesthesia injection and extraction will be done according to the guidelines set by the American Academy of Pediatric Dentistry . After the procedure is done , the participants and their parents will be instructed about post-operative care and the need of a space maintainer will be taken into account. Moreover subjective and objective pain will be assessed and scored during procedure of anesthesia injection and extraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6-8 years\n* Cooperative children ( rating 3 or 4 based on the Frankl behavior scale )\n* Medically fit children (ASA I )\n* Children mentally capable of communication\n* First dental visit\n* Patient requiring extraction of upper primary molars due to root caries , crown fractures, periapical disease and failed pulpotomies\n* No acute dental pain\n\nExclusion Criteria:\n\n* Children with a behavioral management problem\n* Parental refusal of participation\n* Children with previous history of local anesthesia injection\n* Medically unfit children (other than ASA I )\n* Uncooperative children ( other than Frankl 3,4)\n* Children under medications ( antibiotics and analgesics ) for the previous 48 hours that could alter the pain perception\n* Teeth that showed any signs of mobility , ankylosis or root resorption affecting more than one third the root\n* Acute dental pain'}, 'identificationModule': {'nctId': 'NCT07156032', 'briefTitle': 'Effect of Starpen Injection Device Versus Conventional Syringe During Anesthesia and Extraction of Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of the Effect of Computer Controlled Starpen Automatic Injection Device Versus Conventional Syringe on Pain Perception During Infiltration Anesthesia and Extraction of Maxillary Primary Molars : A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'SPen device injection in MPM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Starpen automatic injection device', 'description': 'effect of computer controlled Starpen device on pain perception during infiltration anesthesia and extraction of maxillary primary molars', 'interventionNames': ['Device: Starpen automatic injection device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional syringe', 'description': 'Conventional syringe on pain perception during infiltration anesthesia and extraction of maxillary primary molars', 'interventionNames': ['Procedure: conventional syringe']}], 'interventions': [{'name': 'Starpen automatic injection device', 'type': 'DEVICE', 'otherNames': ['computer controlled injection device'], 'description': 'Starpen device will be used on high speed 45-150s with the conventional carpule of articaine HCL 4% with 1:100,000 epinephrine and short needle', 'armGroupLabels': ['Starpen automatic injection device']}, {'name': 'conventional syringe', 'type': 'PROCEDURE', 'otherNames': ['dental syringe'], 'description': 'injection will be done using conventional metal syringe with articaine HCL 4% with 1:100,000 epinephrine and short needle', 'armGroupLabels': ['Conventional syringe']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ghadeer Mohamed Sayed', 'investigatorAffiliation': 'Cairo University'}}}}