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IRCT20201226049838N1 IRCT 2021-01-12 Shahid Beheshti University of Medical Sciences Comparison of pulpectomy with CEM cement pulpotomy in primary molars Comparison of the success rate of pulpectomy with CEM cement pulpotomy in primary molars; A multicenter Randomized Clinical Trial 2017-07-05 anticipated 100 Complete https://irct.ir/trial/53302 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of teeth will be done by simple randomization method using a web-based randomization service (www.randomizer.org). The generated list of random numbers will be kept by those other than the operators, Blinding description: Children and their parents/caregivers will be blinded, they will not know to which group they belong. The operators can not be blinded due to the nature of the treatments. The clinical outcome assessors will be those other than operators and they will be unaware of the treatment provided to each patient. The radiographic outcome assessors can not be blinded due to the nature of treatments. The data analyzer will just be informed about the aims of the research. He will not know which data set is belong to which group. 4 inflamed radicular pulp of primary molars which is the indication for pulpectomy treatment. Intervention 1: Intervention group: CEM cement pulpotomy: following coronal pulp amputation, hemostasis will be attempted (up to 10 minutes), then CEM cement (BioniqueDent, Tehran, Iran) paste will be inserted to the pulp chamber to cover pulp stumps. The rest of the cavity will then be filled with light-cured resin-modified glass ionomer cement and the tooth will be restored permanently with stainless steal crown. Intervention 2: Intervention group: Metapex Pulpectomy: radiographic working length will be determined and radicular pulp will be extirpated. The canals will be dried with paper points. Root canals will be then filled with Metapex (Calcium Hydroxide + Iodoform) (Meta Biomed Co., Ltd, Korea). The rest of the cavity will be then filled with light-cured resin-modified glass ionomer cement and the tooth will be restored permanently with stainless steal crown. No - There is not a plan to make this available Justification or reason for not sharing IPD is Will be sent on demand of individual researchers
public Saeed Asgary
Iranian Center for Endodontic Research -Daneshjoo Blvd-Velenjak
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2242 7752 saasgary@yahoo.com Shahid Beheshti University of Medical Sciences scientific Alireza Sarraf Shirazi
School of Dentistry-Vakilabad Blvd
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3806 7100 sarrafa@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Pediatric patients aged 4-9 years Primary molars with vital pulps and deep carious lesions Presence of inflamed radicular pulp after pulp amputation (sever bleeding may be present and can be controlled up to 10 min) Tenderness to percussion or spontaneous pain may be present 4 years 9 years Both Evidence of Pulp necrosis Pathologic internal or external root resorption Pathologic mobility Pulp canal obliteration K04.0 Pulpitis Treatment - Other Treatment - Other Intervention group: CEM cement pulpotomy: following coronal pulp amputation, hemostasis will be attempted (up to 10 minutes), then CEM cement (BioniqueDent, Tehran, Iran) paste will be inserted to the pulp chamber to cover pulp stumps. The rest of the cavity will then be filled with light-cured resin-modified glass ionomer cement and the tooth will be restored permanently with stainless steal crown. Intervention group: Metapex Pulpectomy: radiographic working length will be determined and radicular pulp will be extirpated. The canals will be dried with paper points. Root canals will be then filled with Metapex (Calcium Hydroxide + Iodoform) (Meta Biomed Co., Ltd, Korea). The rest of the cavity will be then filled with light-cured resin-modified glass ionomer cement and the tooth will be restored permanently with stainless steal crown. Clinical success rate of CEM cement pulpotomy and Metapex pulpectomy. Timepoint: 6, 12 months. Method of measurement: spontaneous pain, Tenderness to percussion and palpation, gingival swelling, presence of sinus tract/fistula, pathologic mobility. Radiographic success rate of CEM cement pulpotomy and Metapex pulpectomy. Timepoint: 6, 12 months. Method of measurement: Internal root resorption, pathologic external root resorption, furcal/periapical radiolucencies, pulp canal obliteration, periodontal ligament widening, Pathologic involvement of succedaneous tooth. Mashhad University of Medical Sciences Shahid Beheshti University of Medical Sciences Mashhad University of Medical Sciences Approved 2017-06-21 Ethics committee of Mashhad University of Medical Sciences Daneshgah street, Goreishi building Mashhad Razavi Khorasan Iran (Islamic Republic of)