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The aim of this study is to compare treatment outcomes of pulpotomy in mature permanent teeth using Biodentine versus MTA regarding postoperative pain and success rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mineral Trioxide Aggregate (MTA) | Active Comparator |
| |
| Biodentine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MTA Pulpotomy. | Procedure | Pulpotomy using MTA. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain after 6 hours postoperatively | Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents "no pain" 1- 3 readings represent "mild pain" 4- 6 readings represent "moderate pain" 7- 10 readings represent "severe pain" | 6 hours postoperatively |
| Postoperative pain after 12 hours postoperatively | Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents "no pain" 1- 3 readings represent "mild pain" 4- 6 readings represent "moderate pain" 7- 10 readings represent "severe pain" | 12 hours postoperatively |
| Postoperative pain after 24 hours postoperatively | Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents "no pain" 1- 3 readings represent "mild pain" 4- 6 readings represent "moderate pain" 7- 10 readings represent "severe pain" | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Overall (clinical and radiographic) success after 6 months postoperatively. | Outcome of overall success will be determined based on clinical and radiographic examination. If there is either clinical or radiographic failure , then the case will be considered as an overall failure. | 6 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youssef A. Kamal Elalfy, B.D.S | Contact | +201286069484 | Youssef_Andraws@dentistry.cu.edu.eg | |
| Suzan AW Amin, Ph.D. | Contact | swaness@rocketmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Youssef A. Kamal Elalfy, B.D.S. | Cairo University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24771228 | Background | 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. | |
| 29061359 | Background |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
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The study will be participant-blind where the participant will not know the intervention done.
| Biodentine Pulpotomy |
| Procedure |
Pulpotomy using Biodentine |
|
| Overall (clinical and radiographic) success after 12 months postoperatively. |
Outcome of overall success will be determined based on clinical and radiographic examination. If there is either clinical or radiographic failure , then the case will be considered as an overall failure. |
| 12 months postoperatively |
| 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. |
| 28822566 | Background | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |