Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-01-04 @ 1:25 AM
Study NCT ID:
NCT06482593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periapical Healing in Response to Endodontically Treated Teeth With Different Sealing Cement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010485', 'term': 'Periapical Periodontitis'}], 'ancestors': [{'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-06', 'studyFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volumetric Periapical Healing', 'timeFrame': 'Six months follow-up', 'description': 'Changes of the three-dimensional volume of the periapical lesion of endodontic origin'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clinical Trial', 'Endodontic Sealer', 'Periapical healing'], 'conditions': ['Apical Periodontitis']}, 'referencesModule': {'references': [{'pmid': '33540711', 'type': 'BACKGROUND', 'citation': 'Galler KM, Weber M, Korkmaz Y, Widbiller M, Feuerer M. Inflammatory Response Mechanisms of the Dentine-Pulp Complex and the Periapical Tissues. Int J Mol Sci. 2021 Feb 2;22(3):1480. doi: 10.3390/ijms22031480.'}, {'pmid': '29069143', 'type': 'BACKGROUND', 'citation': 'Holland R, Gomes JE Filho, Cintra LTA, Queiroz IOA, Estrela C. Factors affecting the periapical healing process of endodontically treated teeth. J Appl Oral Sci. 2017 Sep-Oct;25(5):465-476. doi: 10.1590/1678-7757-2016-0464.'}, {'pmid': '19121066', 'type': 'BACKGROUND', 'citation': 'Fukada SY, Silva TA, Garlet GP, Rosa AL, da Silva JS, Cunha FQ. Factors involved in the T helper type 1 and type 2 cell commitment and osteoclast regulation in inflammatory apical diseases. Oral Microbiol Immunol. 2009 Feb;24(1):25-31. doi: 10.1111/j.1399-302X.2008.00469.x.'}, {'pmid': '33146332', 'type': 'BACKGROUND', 'citation': 'Neves MAS, Provenzano JC, Fonseca SCL, Rodrigues RCV, Goncalves LS, Siqueira JF Jr, Rocas IN. Disinfection and outcome of root canal treatment using single-file or multifile systems and Ca(OH)2 medication. Braz Dent J. 2020 Sep-Oct;31(5):493-498. doi: 10.1590/0103-6440202003245.'}, {'pmid': '28607360', 'type': 'BACKGROUND', 'citation': 'Yoneda N, Noiri Y, Matsui S, Kuremoto K, Maezono H, Ishimoto T, Nakano T, Ebisu S, Hayashi M. Development of a root canal treatment model in the rat. Sci Rep. 2017 Jun 12;7(1):3315. doi: 10.1038/s41598-017-03628-6.'}, {'pmid': '16215261', 'type': 'BACKGROUND', 'citation': 'Schneeweis LA, Willard D, Milla ME. Functional dissection of osteoprotegerin and its interaction with receptor activator of NF-kappaB ligand. J Biol Chem. 2005 Dec 16;280(50):41155-64. doi: 10.1074/jbc.M506366200. Epub 2005 Oct 7.'}, {'pmid': '16584489', 'type': 'BACKGROUND', 'citation': 'Nair PN. On the causes of persistent apical periodontitis: a review. Int Endod J. 2006 Apr;39(4):249-81. doi: 10.1111/j.1365-2591.2006.01099.x.'}, {'pmid': '31367101', 'type': 'BACKGROUND', 'citation': 'Vishwanath V, Rao HM. Gutta-percha in endodontics - A comprehensive review of material science. J Conserv Dent. 2019 May-Jun;22(3):216-222. doi: 10.4103/JCD.JCD_420_18.'}, {'pmid': '21779066', 'type': 'BACKGROUND', 'citation': 'Shanahan DJ, Duncan HF. Root canal filling using Resilon: a review. Br Dent J. 2011 Jul 22;211(2):81-8. doi: 10.1038/sj.bdj.2011.573.'}, {'pmid': '31815132', 'type': 'BACKGROUND', 'citation': 'Pereira TM, Piva E, Cuevas-Suarez CE, Ricci Volpato LE, Neto MDSDS, Pivatto K, Pecora JD, Borges AH. Experimental Resin-Based Monoblock Endodontic Obturation System. Biomed Res Int. 2019 Nov 7;2019:3512606. doi: 10.1155/2019/3512606. eCollection 2019.'}, {'pmid': '32213767', 'type': 'BACKGROUND', 'citation': 'Komabayashi T, Colmenar D, Cvach N, Bhat A, Primus C, Imai Y. Comprehensive review of current endodontic sealers. Dent Mater J. 2020 Sep 29;39(5):703-720. doi: 10.4012/dmj.2019-288. Epub 2020 Mar 24.'}, {'pmid': '3248573', 'type': 'BACKGROUND', 'citation': 'Eriksen HM, Orstavik D, Kerekes K. Healing of apical periodontitis after endodontic treatment using three different root canal sealers. Endod Dent Traumatol. 1988 Jun;4(3):114-7. doi: 10.1111/j.1600-9657.1988.tb00307.x. No abstract available.'}, {'pmid': '33378579', 'type': 'BACKGROUND', 'citation': 'Tiburcio-Machado CS, Michelon C, Zanatta FB, Gomes MS, Marin JA, Bier CA. The global prevalence of apical periodontitis: a systematic review and meta-analysis. Int Endod J. 2021 May;54(5):712-735. doi: 10.1111/iej.13467. Epub 2021 Jan 22.'}, {'pmid': '30410540', 'type': 'BACKGROUND', 'citation': 'Lo Giudice R, Nicita F, Puleio F, Alibrandi A, Cervino G, Lizio AS, Pantaleo G. Accuracy of Periapical Radiography and CBCT in Endodontic Evaluation. Int J Dent. 2018 Oct 16;2018:2514243. doi: 10.1155/2018/2514243. eCollection 2018.'}, {'pmid': '28707526', 'type': 'BACKGROUND', 'citation': 'Kruse C, Spin-Neto R, Reibel J, Wenzel A, Kirkevang LL. Diagnostic validity of periapical radiography and CBCT for assessing periapical lesions that persist after endodontic surgery. Dentomaxillofac Radiol. 2017 Oct;46(7):20170210. doi: 10.1259/dmfr.20170210. Epub 2017 Jul 14.'}, {'pmid': '37675448', 'type': 'BACKGROUND', 'citation': 'Jalali P, Riccobono J, Augsburger RA, Tahmasbi-Arashlow M. Radiographic patterns of periosteal bone reactions associated with endodontic lesions. Restor Dent Endod. 2023 Jun 8;48(3):e23. doi: 10.5395/rde.2023.48.e23. eCollection 2023 Aug.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to conduct an in vivo study that allows to compare the periapical healing process of 3 different sealing cements through CBCT, as well as implement the evaluation of these lesions through volumetric measurements to provide high-level scientific information and thus have the possibility of being applied in the clinical dental practice, in patients attending UNICOC dental clinics between 2023 and 2024. The main question it aims to answer is:\n\n* Do bioceramic sealer promote faster periapical healing due to their better sealing capacity and high bio-compatibility?\n* Are there no differences between endodontic sealers in terms of apical healing? If there is a comparison group: Researchers will compare Bio-C Sealer (Bioceramic sealer) Zinc-oxide eugenol sealer and AH-Plus epoxy resin sealer to evaluate periapical healing after a six months follow-up of conventional endodontic therapy.\n\nCoronal permanent restoration must be performed no later than 15 days after endodontic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 to 60\n* Patients systemically healthy (ASA I)\n* Patients that require endodontic therapy for single-rooted teeth with pulp necrosis and apical periodontitis (AP).\n* CBCT PAI periapical index score 3 or above, with no symptoms at the time of appointment.\n\nExclusion Criteria:\n\n* Exclusion criteria included other than ASA-1 classification\n* Patients with Perforated cortical plates at cbct analysis\n* Premature permanent teeth\n* Patients with Endodontic-periodontic lesions, dystrophic calcifications, more than 20° root curvature\n* Pregnancy or lactation\n* Root fracture cases\n* Use of analgesics within 12-24 hours root canal therapy and patients with endodontic abscess.'}, 'identificationModule': {'nctId': 'NCT06482593', 'briefTitle': 'Periapical Healing in Response to Endodontically Treated Teeth With Different Sealing Cement', 'organization': {'class': 'OTHER', 'fullName': 'Institucion Universitaria Colegios de Colombia'}, 'officialTitle': 'Periapical Healing in Response to Endodontically Treated Teeth With Different Sealing Cements: An in Vivo Study With CBCT', 'orgStudyIdInfo': {'id': 'NRios_Periapical-Healing_CBCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Groupe 1: ZOE-based sealant', 'description': 'ZOE-based sealant (GROSS-MAN, PROQUIDENT, COL)', 'interventionNames': ['Drug: Zinc-Oxide Eugenol Sealer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Groupe 2: AH-Plus Epoxy Resin Sealer', 'description': 'Epoxy resin-based sealant (AH Plus, Dentsply DeTrey, Konstanz, Germany)', 'interventionNames': ['Drug: AH-Plus Epoxy Resin Sealer']}, {'type': 'EXPERIMENTAL', 'label': 'Groupe 3: Bio-C Sealer', 'description': 'Bioceramic sealer (Bio-C Sealer, ANGELUS, BRA)', 'interventionNames': ['Drug: Bio-C Sealer']}], 'interventions': [{'name': 'Zinc-Oxide Eugenol Sealer', 'type': 'DRUG', 'description': 'Zinc oxide-eugenol sealers have a slow setting time, shrinkage while setting, solubility, and can discolour tooth structure. This sealer group has an advantage in terms of antibacterial activity.It will absorb if extruded into the periradicular tissues.', 'armGroupLabels': ['Groupe 1: ZOE-based sealant']}, {'name': 'AH-Plus Epoxy Resin Sealer', 'type': 'DRUG', 'description': 'Dentsply AH Plus Root Canal Sealing Material is a two-component paste/paste root canal sealer based on epoxy-amine resin. The AH Plus sealer shows extremely low shrinkage making it a suitable choice of material to seal the root canal.', 'armGroupLabels': ['Groupe 2: AH-Plus Epoxy Resin Sealer']}, {'name': 'Bio-C Sealer', 'type': 'DRUG', 'otherNames': ['Bioceramic Sealer'], 'description': "Bio-C® Sealer is a ready-to-use, bioceramic root canal sealer with biologically active ingredients to seal and heal the root canal space. Bio-C Sealer's mechanical and physical properties make it easy to manipulate and seal the canals, while its biological properties and high pH ensure safety and treatment success.", 'armGroupLabels': ['Groupe 3: Bio-C Sealer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111711', 'city': 'Bogotá', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Dental Clinics of the University College of Colombia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institucion Universitaria Colegios de Colombia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dentistry, Specialization in Endodontics, Master in Sciences', 'investigatorFullName': 'Nestor Raúl Rios Osorio', 'investigatorAffiliation': 'Institucion Universitaria Colegios de Colombia'}}}}