Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:32 AM
Study NCT ID:
NCT07427420
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain After Pulpectomy in Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The blinding of operator is not possible due to the nature of the technique used'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative pain', 'timeFrame': 'At 6, 12, 24, 48 and 72 hours and 1 week after Treatment', 'description': ': will be recorded by Asking the patient and/or guardian using a 4-point pain scale at 6, 12, 24, 48 and 72 hours And 1 week after treatment. The parent of each participant will receive 6 flashcards that include four faces and a word describing each face. 0 - None: No pain present.\n\n1. \\- Mild: Pain is present but not distracting; easily ignored.\n2. \\- Moderate: Pain is distracting; manageable but limits activities.\n3. \\- Severe: Intense pain; unable to concentrate, requires immediate action or medication'}], 'secondaryOutcomes': [{'measure': "child's behavior level", 'timeFrame': '(Immediately after treatment)', 'description': 'child\'s behavior level: will be recorded by using FRANKEL behavior rating Scale: rate 1 means definitely negative "refusal of treatment , fearfulness" rate 2 means negative "reluctance to accept treatment , uncooperative" rate 3 means positive "acceptance of treatment , patient follows the dentist\'s directions" rate 4 means definitely positive " good rapport with the dentist , laughter and enjoyment'}, {'measure': 'Clinical Success', 'timeFrame': '( At 3, 6, 12 months)', 'description': '1. Absence of swelling will be recorded by visual examination\n2. Absence of sinus or fistula: will be recorded by visual examination.\n3. Pathologic mobility: will be recorded by mobility test (pressure using the end of two dental mirrors)'}, {'measure': 'Instrumentation time', 'timeFrame': '(During procedure start from anathesia till end of procedure)', 'description': 'will be recorded using a stopwatch'}, {'measure': 'The obturation quality', 'timeFrame': '(Immediately after treatment)', 'description': 'will be assessed using a radiograph(Using Coll and Sadrian criteria)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['single rotary file', 'pulpectomy', 'primary molars', 'manual instrumentation'], 'conditions': ['Irreversible Pulpitis']}, 'descriptionModule': {'briefSummary': 'To compare the post operative pain in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation, through a Randomized Clinical Trial.\n\nThe main question it aims to answer is:\n\nIs there a difference in post operative pain when using single rotary file system versus manual instrumentation in pulpectomy of primary molars?', 'detailedDescription': 'Endodontic procedures remain among the most commonly performed treatments following the diagnosis of pulpal inflammation or pathology. However, in primary teeth, endodontic treatment poses substantial difficulties owing to its complex anatomy and canal systems\n\n* Maintaining a primary tooth after successful root canal treatment is highly beneficial, as the preserved tooth serves as the most effective natural spacemaintainer\n* In cases of irreversible pulpitis, endodontic therapy remains the most common and frequently performed procedure to alleviate pain\n* Pulpectomy in primary molars is a critical treatment modality in pediatric dentistry when the pulp is irreversibly inflamed. Traditional instrumentation for pulpectomy often relies on manual files (e.g., stainless steel K-files), which can be time-consuming, technique sensitive, and may pose challenges due to the complex and delicate root anatomy of primary teeth\n* Rotary nickel-titanium (NiTi) systems have potential advantages: more efficient preparation, reduced chair-time, and possibly better patient cooperation. Indeed, study has found that rotary instrumentation significantly reduces both the instrumentation and obturation time and is associated with lower postoperative pain\n* Postoperative pain is one way to measure the success of endodontic treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients:\n\n * Aged 4-6years, Medically free and Cooperative.\n * Teeth:\n * Restorable mandibular second primary molars with clinical signs or symptoms of irreversible pulpitis.\n\nPre-operative Radiographic criteria:\n\n* Absence of internal or external root resorption.\n* Absence of periapical or inter-radicular radiolucencies.\n\nExclusion Criteria:\n\n* • Patients:\n\n * Uncooperative children.\n * Children with systemic disease.\n * Physical or mental disabilities.\n * Refusal of participation.\n * Unable to attend follow- up visits.\n * Refusal to sign the informed consent.\n\nTeeth:\n\n* Previously accessed teeth.\n* Mobile mandibular primary molars.\n* Pain on percussion.\n* Swelling in the vestibule or on palpation.'}, 'identificationModule': {'nctId': 'NCT07427420', 'briefTitle': 'Postoperative Pain After Pulpectomy in Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Post Operative Pain Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars', 'orgStudyIdInfo': {'id': 'MSc-pedo-pulpectomy-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I pulpectomy using single rotary file system', 'description': 'Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, the root canal patency was checked for all the canals located using a size\n\n#10 (0.02%) k-file then a single rotary file (20 taper 4) will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at the rotational speed 300 rpm with torque set at the lowest level, irrigation with saline', 'interventionNames': ['Device: Fanta AF F one rotary files 20 taper 4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II pulpectomy using manual files system', 'description': 'Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, manual files (k files, Mani, Inc., Japan) size 15,20,25,30 will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion, irrigation with saline', 'interventionNames': ['Device: Manual files (k files ,Mani, Inc., Japan).']}], 'interventions': [{'name': 'Fanta AF F one rotary files 20 taper 4', 'type': 'DEVICE', 'description': 'Fanta AF F one rotary files 20 taper 4 single rotary file system', 'armGroupLabels': ['Group I pulpectomy using single rotary file system']}, {'name': 'Manual files (k files ,Mani, Inc., Japan).', 'type': 'DEVICE', 'description': 'manual files (k files, Mani, Inc., Japan) size 15,20,25,30', 'armGroupLabels': ['Group II pulpectomy using manual files system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11411', 'city': 'Cairo', 'state': 'Egypt', 'country': 'Egypt', 'contacts': [{'name': 'mona a amer, master', 'role': 'CONTACT', 'email': 'mona.amen@dentistry.cu.edu.eg', 'phone': '+201100877939'}, {'name': 'hanaa A Abd El Moniem, phd', 'role': 'CONTACT', 'email': 'hanaa.ibraheem@dentistry.cu.edu.eg'}, {'name': 'mona a amer, master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of Dentistry, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mona A amer, Master', 'role': 'CONTACT', 'email': 'mona.amen@dentistry.cu.edu.eg', 'phone': '+201100877939'}, {'name': 'Hanaa A Abd El Moniem, Phd', 'role': 'CONTACT', 'email': 'hanaa.ibraheem@dentistry.cu.edu.eg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'data is available with the corresponding author on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Candidate in Department of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University', 'investigatorFullName': 'Mona Adel Amer', 'investigatorAffiliation': 'Cairo University'}}}}