Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-27 @ 10:05 PM
Study NCT ID:
NCT04685161
Status:
UNKNOWN
Last Update Posted:
2021-03-30
First Post:
2020-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Surgical Extrusion vs. Fibre Post Restoration for Crown-root Fractured Maxillary Incisors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014082', 'term': 'Tooth Fractures'}], 'ancestors': [{'id': 'D018677', 'term': 'Tooth Injuries'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 groups are used One using fibre post placement And the other using surgical extrusion'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2020-12-16', 'studyFirstSubmitQcDate': '2020-12-24', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic healing of teeth is measured', 'timeFrame': '18 months', 'description': 'Periapical index score(PAI) is used for assessment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fractured Tooth']}, 'descriptionModule': {'briefSummary': 'A total of 124 samples was calculated to be sufficient with G\\*power software ver 3.1.9.2 with effect size of 0.4 alpha probability error and power 0.95.With drop out estimate of 10% the final sample size decided was 140 samples. Patients reporting with complicated(pulp exposed or pulpally involved) horizontal crown root fracture with loss of crown structure in maxillary incisors and radiograph evidence of supra alveolar tooth structure are recruited for study. Informed consent from the patients or guardian as appropriate is obtained as suitable prior to treatment delivery. Exclusion criteria were:patients not willing for recall visits, root with evidence of cervical resorption or roor canal filling, open apices, patient with systemic ailments rendering root canal treatment, compromised periodontal health, vertical or horizontal root fracture. Pulpal condition of tooth was assessed using cold sensibility test(Neosnow, orikam health care Ltd, India.) amd confirmed upon access opening with teeth showing evidence of pulpal bleeding wad categorized as irreversible pulpitis and teeth with no evidence of pulpal bleeding categorized as necrotic pulp.', 'detailedDescription': 'Patients are randomly alloted to treatment groups. Group I-Root canal treatment followed by surgical extrusion of teeth till about 40%supra gingival crown structure is visible clinically.\n\nGroup II-Root canal treatment followed by glass fibre post placement (Reforpost, Angelus, Brazil) and composite (charisma smart, Germany) core build up with porcelain fused metal crown.\n\nPost treatment visits are scheduled 6,12,18 months, scheduled visits were planned as close as possible to the study protocol, but for the purpose of data collection, any recall visit occuring within plus or minus 10% of the advocated time was considered aa occuring at that time. Recall visit check up included clinical examination for mobility, periapical tenderness, gingival pocket depth estimation,bleeding on probing and radiographic examination. Patients are asked to report immediately of any unforeseen circumstances arises in the restored teeth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with complicated crown root fracture\n* patients willing for recall\n* Good oral hygiene\n\nExclusion Criteria:\n\n* patients not willing for recall\n* Patients health rendering root canal treatment'}, 'identificationModule': {'nctId': 'NCT04685161', 'briefTitle': 'Comparison of Surgical Extrusion vs. Fibre Post Restoration for Crown-root Fractured Maxillary Incisors.', 'organization': {'class': 'OTHER', 'fullName': 'Tamil Nadu Dr.M.G.R.Medical University'}, 'officialTitle': 'Comparison of Surgical Extrusion vs Fibre Post Restoration for Crown-root Fractured Maxillary Incisors. Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CSICOLLEGE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgical extrusion', 'description': 'Novel and alternative treatment option for horizontal crown root fractured maxillary incisors', 'interventionNames': ['Procedure: Surgical extrusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fibre post', 'description': 'Treatment modality normally used for crown-root fractured tooth', 'interventionNames': ['Device: Fibre post']}], 'interventions': [{'name': 'Surgical extrusion', 'type': 'PROCEDURE', 'description': 'Invasive treatment option for fractured tooth', 'armGroupLabels': ['Surgical extrusion']}, {'name': 'Fibre post', 'type': 'DEVICE', 'description': 'Easy approach for treatment', 'armGroupLabels': ['Fibre post']}]}, 'contactsLocationsModule': {'locations': [{'zip': '625001', 'city': 'Madurai', 'state': 'Tamil Nadu', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Rahul B Dr, MDS', 'role': 'CONTACT', 'email': 'raghulram22@gmail.com', 'phone': '7598326175'}], 'facility': 'Csi College of Dental Sciences and Research', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}], 'centralContacts': [{'name': 'RAHUL BASKAR, MDS', 'role': 'CONTACT', 'email': 'raghulram22@gmail.com', 'phone': '9 1 7598326175'}, {'name': 'ANAND SHERWOOD, MDS', 'role': 'CONTACT', 'email': 'anand.sherwood@gmail.com', 'phone': '919791443050'}], 'overallOfficials': [{'name': 'ANAND SHERWOOD, MDS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TNMGRMU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tamil Nadu Dr.M.G.R.Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Rahul Baskar', 'investigatorAffiliation': 'Tamil Nadu Dr.M.G.R.Medical University'}}}}