Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA

March 25, 2019 updated by: Youssef Andraws, Cairo University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mineral Trioxide Aggregate (MTA)
Procedure: MTA Pulpotomy.
Pulpotomy using MTA.
Experimental: Biodentine
Procedure: Biodentine Pulpotomy
Pulpotomy using Biodentine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain after 6 hours postoperatively
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall (clinical and radiographic) success after 6 months postoperatively.
Time Frame: 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
Overall (clinical and radiographic) success after 12 months postoperatively.
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Youssef A. Kamal Elalfy, B.D.S., Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

March 17, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 26, 2019

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2019-03-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Symptomatic Irreversible Pulpitis

Clinical Trials on MTA Pulpotomy.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe