Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-31 @ 4:04 PM
Study NCT ID:
NCT05347160
Status:
UNKNOWN
Last Update Posted:
2022-04-26
First Post:
2022-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation Of Different Pulpotomy Agents Used For Treatment Of Immature Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C506393', 'term': 'tricalcium silicate'}, {'id': 'D002126', 'term': 'Calcium Hydroxide'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Evaluate the effect of different pulpotomy medicaments on permanent molars with immature root clinically and radiographically:\n\n1. Calcium Hydroxide\n2. Biodentine\n3. Platelet Rich Fibrin'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2022-03-25', 'studyFirstSubmitQcDate': '2022-04-20', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage % of patients with Success', 'timeFrame': 'Time Frame: 2 years after restoration procedure', 'description': 'Percentage of Success of treated infected immaature teeth with diffrent agent. Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulpotomy', 'Calcium Hydroxide', 'Biodentine', 'Platelet Rich Fibrin', 'Open apex', 'Immature root'], 'conditions': ['Infected Pulp', 'Root Canal Treatment']}, 'descriptionModule': {'briefSummary': 'The management of permanent teeth with incomplete root development with compromised pulpal integrity presents a unique challenge. The loss of pulpal vitality before the completion of dentin deposition leaves a weak root more prone to fracture as a result of the thin dentinal walls. Every attempt should be made to preserve the vitality of these immature teeth until maturation has occured.', 'detailedDescription': "The management of permanent teeth with incomplete root development with compromised pulpal integrity presents a unique challenge. The loss of pulpal vitality before the completion of dentin deposition leaves a weak root more prone to fracture as a result of the thin dentinal walls. Every attempt should be made to preserve the vitality of these immature teeth until maturation has occured. (1)\n\nPulpotomy is a universally accepted treatment modality for pulp exposures in immature permanent teeth to preserve the vitality of the radicular pulp and to ensure continued root development. (2) Calcium Hydroxide has been the most commonly utilized pulpotomy agent for vital pulp therapy. However, owing to disadvantages such as degradation over time, formation of tunnel defects beneath dentinal bridges and poor sealing , it is slowly losing its popularity as a first choice agent for pulpotomy. (3)\n\nVital pulp therapy procedures in permanent teeth with incomplete root development have advanced in recent years. Despite Mineral trioxide aggregate has shown promising potential as a pulpotomy agent , it has some drawbacks that include the presence of toxic elements in the material composition (4) , higher cytotoxicity in its freshly mixed state (5)\n\n,high pH during setting (6) , difficult handling characteristics (7) , long setting time (8) , tooth discoloration (9) and high cost. (10)\n\nConsequently, newer calcium silicate-based materials that retain the desirable properties of original MTA but with easier handling and without tooth discoloration have been introduced . Biodentine has several\n\nadvantages, as its good sealing ability, adequate compressive strength , a relatively short initial setting time and the promotion of reparative dentin formation with a positive effect on vital pulp cells. (11, 12)\n\nRecently, Regenerative Medicine , especially at the molecular and cellular level has been given great attention towards 'regeneration' instead of 'replacement' approaches. (13) resulting in 'vital pulp therapy' and regenerative endodontics Concepts. (14) In such treatments, clean environment is believed to be a necessity for further success.\n\nTriple Antibiotic Paste (TAP) , is a combination of 3 antibiotics, ciprofloxacin , metronidazole and Minocycline is widely used to achieve a relatively aseptic environment in the radicular space so that the tissue repair and healing can occur. (15)\n\nPromising results have attracted endodontists and general dental practitioners to endodontic regenerative procedures (ERPs). (16) which is considered as a form of a revolution in root canal therapy. (17-19) Now, it has now been taken into account as an alternative method to traditional calcium hydroxide-induced apexogenesis. (20-21)\n\nRecently, the paste used in the regeneration and revascularization protocol. Studies have shown that the paste can eliminate the root canal microorganisms by removing the diverse groups of obligate and facultative gram-positive and gram-negative bacteria , providing an environment for healing. (22,23)\n\nPlatelet-rich fibrin (PRF) is a recent innovation in dentistry that has been prepared and used in 2001. (24) It is considered as an autologous healing biomaterial incorporating leukocytes, platelets, and a wide range of key healing proteins in a dense fibrin matrix. (25) PRF serves as a reservoir for the slow continuous release of growth factors that influence and direct the processes of reparative dentinogenesis (26) . Huang et al (27) investigated the effect of PRF on cultured primary dental pulp cells and concluded that PRF can increase dental pulp cell proliferation and differentiation.\n\nGrowth factors included in PRF are mitogenic , chemotactic and angiogenic. Therefore, they appear to be critical to the wound-healing process. PRF induces osteoblasts, gingival fibroblasts, and periodontal ligament cells proliferation as a mitogen . Because of growth factors concentrates, PRF promotes wound healing and regeneration which is used in various disciplines of dentistry to repair and regenerate dental and oral tissues. (28-30)\n\nPRF has anti-inflammatory effect and act as an immune regulation mode. It presented as a perfect scaffold in revascularization of immature permanent teeth with necrotic pulps as it enhances cellular proliferation and differentiation. (31,32)\n\nHowever, there is a limited number of studies reporting on the success of vital pulp therapy for Immature permanent molars. So, the present study will evaluate different pulpotomy modalities used in Immature permanent molars."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apparent healthy and free from any systemic diseases\n* child should have restorable carious first permanent molars with immature root\n\nExclusion Criteria:\n\n* presence of signs and symptoms of pulp degenration\n* presence of internal and external root resorption'}, 'identificationModule': {'nctId': 'NCT05347160', 'briefTitle': 'Evaluation Of Different Pulpotomy Agents Used For Treatment Of Immature Molars', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Evaluation Of Different Pulpotomy Agents Used For Treatment Of Immature Molars (Clinical Trial)', 'orgStudyIdInfo': {'id': 'A04080920'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'calcium hydroxide : group 1', 'description': 'Immature permanent molars with immature root filled by ca(oh)2', 'interventionNames': ['Procedure: Biodentine']}, {'type': 'EXPERIMENTAL', 'label': 'biodentine : group 2', 'description': 'clinically and radiographically evaluate BIODENTINE effect on permanent molars with immature root', 'interventionNames': ['Procedure: Biodentine']}, {'type': 'EXPERIMENTAL', 'label': 'platelet rich fibrin : group 3', 'description': 'filling of permanent molars with immature root by platelet rich fibrin', 'interventionNames': ['Procedure: Biodentine']}], 'interventions': [{'name': 'Biodentine', 'type': 'PROCEDURE', 'otherNames': ['Platelet Rich Fibrin (PRF)', 'Calcium Hydroxide CA(oh)2'], 'description': 'using of biodentine , calcium hydroxide and platelet rich fibrin as pulpotomy agents', 'armGroupLabels': ['biodentine : group 2', 'calcium hydroxide : group 1', 'platelet rich fibrin : group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'state': 'Dakhalia', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Salwa M Awad, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'head of pediatric dentistry and public health department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}