Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA

NCT ID: NCT03890835

Last Updated: 2019-03-26

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-31

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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* 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.

Conditions

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Symptomatic Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The study will be participant-blind where the participant will not know the intervention done.

Study Groups

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Mineral Trioxide Aggregate (MTA)

Group Type ACTIVE_COMPARATOR

MTA Pulpotomy.

Intervention Type PROCEDURE

Pulpotomy using MTA.

Biodentine

Group Type EXPERIMENTAL

Biodentine Pulpotomy

Intervention Type PROCEDURE

Pulpotomy using Biodentine

Interventions

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MTA Pulpotomy.

Pulpotomy using MTA.

Intervention Type PROCEDURE

Biodentine Pulpotomy

Pulpotomy using Biodentine

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Youssef Andraws

Postgraduate Student, Department of Endodontics, Faculty of Dentistry, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Youssef A. Kamal Elalfy, B.D.S.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

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Youssef A. Kamal Elalfy, B.D.S

Role: CONTACT

+201286069484

Suzan AW Amin, Ph.D.

Role: CONTACT

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.

Reference Type BACKGROUND
PMID: 24771228 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29061359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28822566 (View on PubMed)

Other Identifiers

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CEBD-CU-2019-03-10

Identifier Type: -

Identifier Source: org_study_id

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