Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA

NCT03890835 | Unknown

• 1 other identifier: CEBD-CU-2019-03-10
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Symptomatic Irreversible Pulpitis

Keywords

Pulpotomy; Mineral Trioxide Aggregate (MTA); Biodentine; Vital pulp therapy; Postoperative pain; Overall success

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Overall (clinical and radiographic) success after 6 months postoperatively.

  6 months postoperatively

• Overall (clinical and radiographic) success after 12 months postoperatively.

  12 months postoperatively

Study Arms (2)

Mineral Trioxide Aggregate (MTA)

ACTIVE COMPARATOR

Procedure: MTA Pulpotomy.

Biodentine

EXPERIMENTAL

Procedure: Biodentine Pulpotomy

Interventions

MTA Pulpotomy. PROCEDURE

Pulpotomy using MTA.

Mineral Trioxide Aggregate (MTA)

Biodentine Pulpotomy PROCEDURE

Pulpotomy using Biodentine

Biodentine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (3)

• 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.

  PMID: 24771228 BACKGROUND

• 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.

  PMID: 29061359 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.

  PMID: 28822566 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Youssef A. Kamal Elalfy, B.D.S.

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youssef A. Kamal Elalfy, B.D.S

CONTACT

+201286069484; Youssef_Andraws@dentistry.cu.edu.eg

Suzan AW Amin, Ph.D.

CONTACT

swaness@rocketmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study will be participant-blind where the participant will not know the intervention done.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Student, Department of Endodontics, Faculty of Dentistry, Cairo University

Model Details: Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: March 26, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share