Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA
NCT ID: NCT03890835
Last Updated: 2019-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2019-05-31
2020-05-31
Brief Summary
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Detailed Description
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* Eligible patients will be randomly assigned to one of 2 groups: experimental group (pulpotomy using Biodentine) and the control group (pulpotomy using MTA).
* After adminsrtation of local anesthesia, pulpotomy will be done under rubber dam isolation. The pulp tissue will be removed until the level of the orifices of the canals. After hemostasis is achieved, the capping material will be placed. In the experimental group, the capping material is Biodentine while in the control group, the capping material is MTA
* The cavities will be sealed with resin-modified glass ionomer. Then the teeth will be permanently restored with composite . A post-operative radiograph will be taken.
* The patients will be given a pain diary based on Numerical Rating Scale (NRS) and asked to rate their pain level at the specified times.
* The patients will be recalled after 6 and 12 months post-operatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mineral Trioxide Aggregate (MTA)
MTA Pulpotomy.
Pulpotomy using MTA.
Biodentine
Biodentine Pulpotomy
Pulpotomy using Biodentine
Interventions
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MTA Pulpotomy.
Pulpotomy using MTA.
Biodentine Pulpotomy
Pulpotomy using Biodentine
Eligibility Criteria
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Inclusion Criteria
* Patients with symptomatic irreversible pulpitis.
* Radiographically: Absence or slight widening in periodontal ligament space.
* Systemically- healthy patients (ASA I or II).
* Patients who agree to attend for recall appointments and provide written consent.
Exclusion Criteria
* Necrotic pulp, pulp polyp, tooth tender to percussion, clinical progression into periapical abscess, fistula.
* Non-restorable teeth, teeth with internal/external root resorption or root canal calcification.
18 Years
40 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Youssef Andraws
Postgraduate Student, Department of Endodontics, Faculty of Dentistry, Cairo University
Principal Investigators
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Youssef A. Kamal Elalfy, B.D.S.
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Central Contacts
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References
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Asgary S, Eghbal MJ, Fazlyab M, Baghban AA, Ghoddusi J. Five-year results of vital pulp therapy in permanent molars with irreversible pulpitis: a non-inferiority multicenter randomized clinical trial. Clin Oral Investig. 2015 Mar;19(2):335-41. doi: 10.1007/s00784-014-1244-z. Epub 2014 Apr 27.
Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.
Bakhtiar H, Nekoofar MH, Aminishakib P, Abedi F, Naghi Moosavi F, Esnaashari E, Azizi A, Esmailian S, Ellini MR, Mesgarzadeh V, Sezavar M, About I. Human Pulp Responses to Partial Pulpotomy Treatment with TheraCal as Compared with Biodentine and ProRoot MTA: A Clinical Trial. J Endod. 2017 Nov;43(11):1786-1791. doi: 10.1016/j.joen.2017.06.025. Epub 2017 Aug 16.
Other Identifiers
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CEBD-CU-2019-03-10
Identifier Type: -
Identifier Source: org_study_id
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