Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT07239050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraosseus Injection Using Extra-short Needle Combined With Infiltration in Pediatric Patients With Molar Incisor Hypomineralization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094604', 'term': 'Molar Hypomineralization'}], 'ancestors': [{'id': 'D000094603', 'term': 'Dental Enamel Hypomineralization'}, {'id': 'D000094602', 'term': 'Developmental Defects of Enamel'}, {'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in objective pain reaction', 'timeFrame': 'throughout the procedure', 'description': 'Pain response will be assessed using Face, Legs, Activity, Cry Consolability (FLACC) scale The scale has five criteria, each assigned a score of 0, 1 or 2 (zero means no pain and 2 means severe pain). The total score scale is scored in a range of 0-10 with 0 representing no pain'}, {'measure': 'Change in subjective pain scores', 'timeFrame': 'throughout the procedure', 'description': 'It will be done by the child using Wong-Baker Faces Pain Rating Scale that ranged from 0 to 5. zero means no pain and 5 means pain is severe'}], 'secondaryOutcomes': [{'measure': 'Local anesthesia efficacy', 'timeFrame': 'throughout the procedure', 'description': 'The Efficacy of local anesthesia to complete the restorative procedure successfully without pain will be evaluated by Efficacy Scale'}, {'measure': 'change in child anxiety', 'timeFrame': 'throughout the procedure', 'description': 'It will be assessed using Venham Clinical Anxiety Scale (VCAS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Molar Hypomineralization']}, 'descriptionModule': {'briefSummary': 'Background: Effective pain control is crucial in managing pediatric dental patients. Molar-incisor hypomineralization (MIH), marked by enamel defects and dentin hypersensitivity, often hinders effective local anesthesia. Traditional injection methods may fall short, causing discomfort and complicating treatment. Combining infiltration with intraosseous injection using an extra-short 31-G needle may offer a more effective alternative.\n\nPurpose: To compare the effectiveness of combined infiltration and intraosseous injection with an extra-short 31-G needle versus conventional techniques in eliminating pain during'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy children, American Society of Anesthesiologists class I, II\n* Cooperative children during preoperative assessments according to the Frankl'\n* Behavioral Rating Scale (scores 3 or 4)\n* Patient presenting with at least one hypersensitive SCASS 2,3 \\[22\\] (Appendix III) deeply carious, MIH-affected FPM, with caries extending to the inner third of the dentin and close to the pulp, as shown in the periapical radiograph, consistent with TNI 4c classification for MIH\n* Written consent of the legal guardian.\n\nExclusion Criteria:\n\n* Any physical or mental disability or psychological problems.\n* Immunocompromised patients.\n* Hypersensitivity to local anesthetic drugs used.\n* Taking analgesics or other medications that alter the child's behavior or awareness of pain 12- hours pre-operatively\n* Patients requiring emergency treatment.\n* FPM with preoperative signs and symptoms of clinical failure"}, 'identificationModule': {'nctId': 'NCT07239050', 'briefTitle': 'Intraosseus Injection Using Extra-short Needle Combined With Infiltration in Pediatric Patients With Molar Incisor Hypomineralization', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effectiveness of Intraosseus Injection Using Extra-short Needle Combined With Infiltration in Pediatric Patients With Molar Incisor Hypomineralization (A Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': '1109-07/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraosseous', 'interventionNames': ['Other: intraosseus anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional nerve block', 'interventionNames': ['Other: Conventional nerve block']}], 'interventions': [{'name': 'intraosseus anesthesia', 'type': 'OTHER', 'description': 'MIH-affected hypersensitive deeply carious FPM extending into the inner 1/3 of the dentin mandibular FPM allocated to be anesthesized using infiltration followed by intraosseus anesthesia using extra-short 31-G needle.', 'armGroupLabels': ['Intraosseous']}, {'name': 'Conventional nerve block', 'type': 'OTHER', 'description': 'MIH affected hypersensitive deeply carious FPM extending into the inner 1/3 of the dentin mandibular FPM allocated to be anesthesized using long 30-G needle (IANB) and short 30-G short needle (buccal infiltration).', 'armGroupLabels': ['Conventional nerve block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00203', 'city': 'Alexandria', 'state': 'Azarita', 'country': 'Egypt', 'contacts': [{'name': 'Faculty of Dentistry', 'role': 'CONTACT', 'phone': '(203) 4868308'}, {'name': 'Raghad Nassar, BDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Outpatient clinics of Faculty of Dentistry, Alexandria University, Egypt', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Raghad Nassar, BDS', 'role': 'CONTACT', 'email': 'raghadnassarr96@gmail.com', 'phone': '01001717301'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}