Clinical trial NCT03890835: Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA
Official title: Comparative Evaluation of Postoperative Pain and Success Rate After Pulpotomy in Mature Permanent Molars Using Biodentine Versus Mineral Trioxide Aggregate (MTA) as Capping Materials: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Symptomatic Irreversible Pulpitis
Keywords: Pulpotomy
Mineral Trioxide Aggregate (MTA)
Biodentine
Vital pulp therapy
Postoperative pain
Overall success
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: * Patients will be clinically and radiographically examined and their eligibility will be assessed.
* 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.

Eligibility criteria: Inclusion Criteria:

* Patients aging between 18-40 years old
* 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:

* Severe marginal periodontitis.
* 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.

Primary outcomes:
measure: Postoperative pain after 6 hours postoperatively
timeFrame: 6 hours postoperatively
measure: Postoperative pain after 12 hours postoperatively
timeFrame: 12 hours postoperatively
measure: Postoperative pain after 24 hours postoperatively
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Overall (clinical and radiographic) success after 6 months postoperatively.
timeFrame: 6 months postoperatively
measure: Overall (clinical and radiographic) success after 12 months postoperatively.
timeFrame: 12 months postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Youssef A. Kamal Elalfy, B.D.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.