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MTA vs CEM Pulpotomy in Young Permanent Molars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243733
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Marwa Sharaan, Suez Canal University

Brief Summary:

The aim of the study

The purpose of this present clinical study will be to assess :

" the successful clinical outcome of CEM cement in comparison to MTA in the pulpotomy of young permanent molar teeth with irreversible pulpitis .

" the successful radiographic outcome of CEM cement in comparison to MTA in the pulpotomy of young permanent molar teeth with irreversible pulpitis.


Condition or disease Intervention/treatment Phase
Irreversible Pulpitis Other: CEM and MTA Other: MTA and CEM Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: MTA vs CEM Pulpotomy in Young Permanent Molars With a Diagnosis of Irreversible Pulpitis: A Randomized Clinical Trial
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : December 10, 2020
Estimated Study Completion Date : January 10, 2021

Arm Intervention/treatment
calcium enriched mixture material (CEM)
Using CEM as a pulpotomy agent against MTA pulpotomy agent.
Other: CEM and MTA
Pulpotomy agent

Other: MTA and CEM
Pulpotomy agent

Experimental: Mineral trioxide aggregate material (MTA)
Using MTA as a pulpotomy agent against CEM pulpotomy agent.
Other: CEM and MTA
Pulpotomy agent

Other: MTA and CEM
Pulpotomy agent




Primary Outcome Measures :
  1. the successful clinical outcome of CEM cement in comparison to MTA in the pulpotomy of young permanent molar teeth with irreversible pulpitis . [ Time Frame: one year follow up after starting the case ]
    clinical signs and symptoms and testing sensibility of the pulp by cold test

  2. the successful radiographic outcome of CEM cement in comparison to MTA in the pulpotomy of young permanent molar teeth with irreversible pulpitis. [ Time Frame: one year follow up after starting the case ]
    healing of apical radiolucency, no occurrence of apical radiolucency



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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Clinical examination reveals extended carious lesion on the molar teeth surface not extending toward the root. All of the patients report a history of pain typical of irreversible pulpitis ie; the chief complaints are of spontaneous pain lasting from a few seconds to several hours in the days before consultation. This radiating pain is exacerbated by hot and cold fluids and require analgesia for pain relief. The pain does not abate following tooth brushing or flossing. All of the parents are willing to join the study. All teeth are believed to be vital and the vitality of all the subjected molar teeth was checked by the operator during the pulpotomy procedure through visual inspection of pulpal hemorrhage.

Exclusion Criteria:

  • Clinical examination reveals extended carious lesion on the molar teeth surfaces not extending toward the root. All of the patients report a history of pain typical of irreversible pulpitis ie; the chief complaints are of spontaneous pain lasting from a few seconds to several hours in the days before consultation. This radiating pain is exacerbated by hot and cold fluids and require analgesia for pain relief. The pain does not abate following tooth brushing or flossing. All of the parents are willing to join the study. All teeth are believed to be vital and the vitality of all the subjected molar teeth was checked by the operator during the pulpotomy procedure through visual inspection of pulpal hemorrhage.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243733


Contacts
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Contact: marwa E Sharaan, PhD 00201000984071 marwaelsayedsharaan@gmail.com

Locations
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Egypt
Marwa Recruiting
Ismailia, Egypt
Contact: marwa e sharaan, PhD    01000984071    marwaelsayedsharaan@gmail.com   
Sponsors and Collaborators
Suez Canal University
Publications of Results:
References: [1] Smaïl-Faugeron V, Courson F, Durieux P, Muller-Bolla M, Glenny AM, Fron Chabouis H. Pulp treatment for extensive decay in primary teeth. Cochrane Database Syst Rev 2014; 8(8): CD003220. [2] Tannure PN, Azevedo CP, Barcelos R, Gleiser R, Primo LG. Long-term outcomes of primary tooth pulpectomy with and without smear layer removal: a randomized split-mouth clinical trial. Pediatr Dent 2011; 33(4): 316-20. [3] Barcelos R, Tannure PN, Gleiser R, Luiz RR, Primo LG. The influence of smear layer removal on primary tooth pulpectomy outcome: a 24-month, double-blind, randomized, and controlled clinical trial evaluation. Int J Paediatr Dent 2012; 22(5): 369-81. [4] McDougal RA, Delano EO, Caplan D, Sigurdsson A, Trope M. Success of an alternative for interim management of irreversible pulpitis. J Am Dent Assoc 2004; 135(12): 1707-12. [5] Barrieshi-Nusair KM, Qudeimat MA. A prospective clinical study of mineral trioxide aggregate for partial pulpotomy in cariously exposed permanent teeth. J Endod 2006; 32(8): 731-5. [6] Eghbal MJ, Asgary S, Baglue RA, Parirokh M, Ghoddusi J. MTA pulpotomy of human permanent molars with irreversible pulpitis. Aust Endod J 2009; 35(1): 4-8. [7] Holan G, Eidelman E, Fuks AB. Long-term evaluation of pulpotomy in primary molars using mineral trioxide aggregate or formocresol. Pediatr Dent 2005; 27(2): 129-36. [8] Noorollahian H. Comparison of mineral trioxide aggregate and formocresol as pulp medicaments for pulpotomies in primary molars. Br Dent J 2008; 204(11): E20. [9] Simancas-Pallares MA, Díaz-Caballero AJ, Luna-Ricardo LM. Mineral trioxide aggregate in primary teeth pulpotomy. A systematic literature review. Med Oral Patol Oral Cir Bucal 2010; 1(15): e 942-6. [10] Asgary S, Shahabi S, Jafarzadeh T, Amini S, Kheirieh S. The properties of a new endodontic material. J Endod 2008; 34(8): 990-3. [11] Amini Ghazvini S, Abdo Tabrizi M, Kobarfard F, Akbarzadeh Baghban A, Asgary S. Ion release and pH of a new endodontic cement, MTA and Portland cement. Iran Endod J 2009; 4(2): 74-8] [12] Asgary S, Kamrani FA. Antibacterial effects of five different root canal sealing materials. J Oral Sci 2008; 50(4): 469-74. [13] Asgary S, Eghbal MJ. Treatment outcomes of pulpotomy in permanent molars with irreversible pulpitis using biomaterials: a multi-center randomized controlled trial. Acta Odontol Scand 2013; 71(1): 130-6. [14] Asgary S, Eghbal MJ, Ghoddusi J, Yazdani S. One-year results of vital pulp therapy in permanent molars with irreversible pulpitis: an ongoing multicenter, randomized, non-inferiority clinical trial. Clin Oral Investig 2013; 17(2): 431-9. [15] Tabarsi B, Parirokh M, Eghbal MJ, Haghdoost AA, Torabzadeh H, Asgary S. A comparative study of dental pulp response to several pulpotomy agents. Int Endod J 2010; 43(7): 565-71. [16] Nosrat A, Asgary S. Apexogenesis of a symptomatic molar with calcium enriched mixture. Int Endod J 2010; 43(10): 940-4. [17] Nosrat A, Seifi A, Asgary S. Pulpotomy in caries-exposed immature permanent molars using calcium-enriched mixture cement or mineral trioxide aggregate: a randomized clinical trial. Int J Paediatr Dent 2013; 23(1): 56-63. [18] Asgary S, Eghbal MJ, Ehsani S. Periradicular regeneration after endodontic surgery with calcium-enriched mixture cement in dogs. J Endod 2010; 36(5): 837-41. [19] Asgary S, Eghbal MJ. The effect of pulpotomy using a calcium-enriched mixture cement versus one-visit root canal therapy on postoperative pain relief in irreversible pulpitis: a randomized clinical trial. Odontology 2010; 98(2): 126-33. [20] Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods 2007; 39(2): 175-91.

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Responsible Party: Marwa Sharaan, Associate Professor, Suez Canal University
ClinicalTrials.gov Identifier: NCT04243733    
Other Study ID Numbers: 110/2018
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors