Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT03786302
Status:
TERMINATED
Last Update Posted:
2020-10-14
First Post:
2018-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Regenerative Ability of TAMP BG and BD in Pulpotomized Primary Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C506393', 'term': 'tricalcium silicate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The operator will not be blinded to the treatment type. However, the participants, their care givers, the expert assessing the histologic and inflammatory changes and the statistician will be blinded to the treatment groups.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study group (assigned to TAMP bioglass), and Control group (assigned to Biodentine ™).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'whyStopped': 'Failure rate was 100% in one arm of the study (the intervention)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-11', 'studyFirstSubmitDate': '2018-12-18', 'studyFirstSubmitQcDate': '2018-12-19', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence of clinical signs of pulp degeneration.', 'timeFrame': '1 month postoperatively', 'description': 'Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility'}, {'measure': 'Percentage of Teeth with no clinical signs of pulp degeneration.', 'timeFrame': '3 months postoperatively', 'description': 'Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility'}, {'measure': 'Percentage of Teeth with no clinical signs of pulp degeneration.', 'timeFrame': '6 months postoperatively', 'description': 'Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility'}, {'measure': 'Percentage of Teeth with no clinical signs of pulp degeneration.', 'timeFrame': '9 months postoperatively', 'description': 'Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility'}, {'measure': 'Percentage of Teeth with no clinical signs of pulp degeneration.', 'timeFrame': '12 months postoperatively', 'description': 'Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility'}, {'measure': 'Percentage of Teeth with no radiographic signs of pulp degeneration.', 'timeFrame': '6 months postoperatively', 'description': 'Digital postoperative periapical radiographs were obtained and assessed for signs of pulp degeneration. Teeth were considered radiographically successful when they showed no periapical or interradicular radiolucency, abnormal root resorption or periodontal ligament space widening'}, {'measure': 'Percentage of Teeth with no radiographic signs of pulp degeneration.', 'timeFrame': '12 months postoperatively', 'description': 'Digital postoperative periapical radiographs were obtained and assessed for signs of pulp degeneration. Teeth were considered radiographically successful when they showed no periapical or interradicular radiolucency, abnormal root resorption or periodontal ligament space widening'}], 'secondaryOutcomes': [{'measure': 'Percentage of teeth with radiographic evidence of dentin bridge formation', 'timeFrame': '6 months postoperatively', 'description': 'Assessed using digital radiographs'}, {'measure': 'Percentage of teeth with radiographic evidence of dentin bridge formation', 'timeFrame': '12 months postoperatively', 'description': 'Assessed using digital radiographs'}, {'measure': 'Dentin bridge formation using light microscopy', 'timeFrame': '6 weeks', 'description': "After tooth extraction, histological assessment will be done according to Horsted et al's (1981) and Shayegan et al's (2012) modified criteria.\n\n0= No hard tissue formation.\n\n1. Incomplete hard tissue formation.\n2. Thick hard tissue formation."}, {'measure': 'Inflammatory response using light microscopy', 'timeFrame': '6 weeks', 'description': "After tooth extraction, histological assessment will be done according to Horsted et al's (1981) and Shayegan et al's (2012) modified criteria. A. Inflammatory cell response:\n\n0= None or a few scattered inflammatory cells beneath the site of pulp exposure.\n\n1. Mild inflammatory cells (either acute or chronic).\n2. Moderate inflammatory cell infiltration involving the cervical third of radicular pulp.\n3. Severe inflammatory cell infiltration involving the coronal third of radicular pulp.\n\nB. Tissue disorganization:\n\n0= Normal tissue beneath the site of pulp exposure.\n\n1. Odontoblast-like cells, odontoblasts, and pulp tissue pattern disorganization.\n2. General disorganization of the pulp tissue pattern.\n3. Pulp necrosis."}, {'measure': 'The Enzyme-Linked Immunosorbent Assay (ELISA) analysis.', 'timeFrame': '6 weeks', 'description': "After extraction, the tooth will be sectioned under copious water cooling and all remaining pulp tissue will be harvested gently from the radicular portion and stored until the time of assaying. For the ELISA assaying, the frozen pulp samples will be thawed for 15 minutes, and crushed with a glass rod in the eppendorf tube to elute the cytokines from the pulp tissue. IL-8 and IL-10 will be measured using ElISA Kits according to the instructions supplied with the kit and the ratio of IL-8/IL-10 will be taken as an indicator of pulpal inflammation. Cytokines' concentration will be calculated according to the weight of the pulp tissue."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TAMP BG', 'Biodentine', 'Regenerative materials', 'pulp therapy'], 'conditions': ['Pulpotomy']}, 'referencesModule': {'references': [{'pmid': '21445655', 'type': 'BACKGROUND', 'citation': 'Wang S, Falk MM, Rashad A, Saad MM, Marques AC, Almeida RM, Marei MK, Jain H. Evaluation of 3D nano-macro porous bioactive glass scaffold for hard tissue engineering. J Mater Sci Mater Med. 2011 May;22(5):1195-203. doi: 10.1007/s10856-011-4297-4. Epub 2011 Mar 29.'}, {'pmid': '23427819', 'type': 'BACKGROUND', 'citation': 'Wang S, Kowal TJ, Marei MK, Falk MM, Jain H. Nanoporosity significantly enhances the biological performance of engineered glass tissue scaffolds. Tissue Eng Part A. 2013 Jul;19(13-14):1632-40. doi: 10.1089/ten.TEA.2012.0585. Epub 2013 Mar 26.'}, {'pmid': '11699742', 'type': 'BACKGROUND', 'citation': 'Stanley HR, Clark AE, Pameijer CH, Louw NP. Pulp capping with a modified bioglass formula (#A68-modified). Am J Dent. 2001 Aug;14(4):227-32.'}, {'pmid': '6946381', 'type': 'BACKGROUND', 'citation': 'Horsted P, El Attar K, Langeland K. Capping of monkey pulps with Dycal and a Ca-eugenol cement. Oral Surg Oral Med Oral Pathol. 1981 Nov;52(5):531-53. doi: 10.1016/0030-4220(81)90366-2.'}, {'pmid': '23265156', 'type': 'BACKGROUND', 'citation': 'Shayegan A, Jurysta C, Atash R, Petein M, Abbeele AV. Biodentine used as a pulp-capping agent in primary pig teeth. Pediatr Dent. 2012 Nov-Dec;34(7):e202-8.'}, {'pmid': '33409691', 'type': 'DERIVED', 'citation': 'Elhamouly Y, El Backly RM, Talaat DM, Omar SS, El Tantawi M, Dowidar KML. Tailored 70S30C Bioactive glass induces severe inflammation as pulpotomy agent in primary teeth: an interim analysis of a randomised controlled trial. Clin Oral Investig. 2021 Jun;25(6):3775-3787. doi: 10.1007/s00784-020-03707-5. Epub 2021 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to assess clinically, radiographically, and histologically the regenerative ability of Tailored Amorphous Mulioporous (TAMP-BG) bioglass in comparison to Biodentine™ (BD) in pulpotomized primary teeth.', 'detailedDescription': 'The study was a parallel design, randomized controlled clinical trial It was conducted in the out-patient clinic of the Pediatric Dentistry and Dental public health department after obtaining the guardians consent. The sample size was calculated to be 35 teeth per group. The teeth were randomly and equally assigned to either BD or TAMP-BG groups.The treatment follow-up was scheduled at 1, 3, 6, 9 and 12 months. The study was terminated for ethical considerations after showing significant clinical failure in the TAMP-BG group and after performing interim analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children free of any systemic disease or special health care needs.\n* Children not receiving any anti-inflammatory medication.\n* Cooperative children (positive/ definitely positive) according to Frankl's behavior rating scale.\n* Restorable teeth.\n* Teeth with vital carious pulp exposure that will bleed upon entering the pulp chamber and not requiring more than 5 minutes to achieve hemostasis after coronal pulp amputation.\n* Teeth indicated for extraction for orthodontic purposes with the previously mentioned criteria (required for a subgroup for assessment of histological and inflammatory response outcomes).\n\nExclusion Criteria:\n\n* Teeth with clinical or radiographic signs of pulp degeneration."}, 'identificationModule': {'nctId': 'NCT03786302', 'briefTitle': 'Regenerative Ability of TAMP BG and BD in Pulpotomized Primary Teeth', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'Comparison of the Regenerative Ability of Tailored Amorphous Multiporous Bioglass and Biodentine in Pulpotomized Primary Teeth', 'orgStudyIdInfo': {'id': 'Bioglass in pulpotomized teeth'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAMP bioglass', 'description': 'Tailored amorphous multiporous bioglass (TAMP-BG) of 70% SiO2 / 30% CaO was prepared according to Wang et al. (2011, 2013) in the tissue engineering lab, Faculty of Dentistry, Alexandria University as follows: Scaffolds were grounded to 180- to 300-μm particle size and sterilized at 180°C for 2 hours. The resulting powder was mixed with distilled water to obtain a putty like consistency that was carried to the pulp chamber and condensed lightly on the pulp stumps.', 'interventionNames': ['Drug: TAMP bioglass']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biodentine ™', 'description': "Biodentine ™ (BD) pre-dosed capsule were gently tapped on a hard surface to diffuse the powder. Five drops of the liquid from the single dose dispenser were poured into the capsule and mixed for 30 seconds at 4,200 rpm in an amalgamator according to manufacturer's instructions to obtain putty- like consistency. (Powder-liquid system). It was then be carried to the pulp chamber and condensed lightly on the pulp stumps. Final restoration was applied after 12 minutes, allowing Biodentine ™ to set.", 'interventionNames': ['Drug: Biodentine']}], 'interventions': [{'name': 'TAMP bioglass', 'type': 'DRUG', 'otherNames': ['70S30C bioglass'], 'description': 'TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth', 'armGroupLabels': ['TAMP bioglass']}, {'name': 'Biodentine', 'type': 'DRUG', 'description': 'TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth', 'armGroupLabels': ['Biodentine ™']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21512', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Yasmine I El-Hamouly, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}, {'name': 'Karin ML Dowidar, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}, {'name': 'Samia Soliman, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}, {'name': 'Dalia AM Talaat, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}, {'name': 'Rania M El Backly, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nourhan M.Aly', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alexandria University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Instructor', 'investigatorFullName': 'Nourhan M.Aly', 'investigatorAffiliation': 'University of Alexandria'}}}}