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Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890835
Recruitment Status : Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Youssef Andraws, Cairo University

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.

Condition or disease Intervention/treatment Phase
Symptomatic Irreversible Pulpitis Procedure: MTA Pulpotomy. Procedure: Biodentine Pulpotomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
Masking: Single (Participant)
Masking Description: The study will be participant-blind where the participant will not know the intervention done.
Primary Purpose: Treatment
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
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Active Comparator: Mineral Trioxide Aggregate (MTA) Procedure: MTA Pulpotomy.
Pulpotomy using MTA.

Experimental: Biodentine Procedure: Biodentine Pulpotomy
Pulpotomy using Biodentine




Primary Outcome Measures :
  1. 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"


  2. 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"


  3. 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"



Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890835


Contacts
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Contact: Youssef A. Kamal Elalfy, B.D.S +201286069484 Youssef_Andraws@dentistry.cu.edu.eg
Contact: Suzan AW Amin, Ph.D. swaness@rocketmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Youssef A. Kamal Elalfy, B.D.S. faculty of dentistry Cairo university
Publications:
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Responsible Party: Youssef Andraws, Postgraduate Student, Department of Endodontics, Faculty of Dentistry, Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT03890835    
Other Study ID Numbers: CEBD-CU-2019-03-10
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Youssef Andraws, Cairo University:
Pulpotomy
Mineral Trioxide Aggregate (MTA)
Biodentine
Vital pulp therapy
Postoperative pain
Overall success
Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases