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Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA

Primary Purpose

Symptomatic Irreversible Pulpitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MTA Pulpotomy.
Biodentine Pulpotomy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Irreversible Pulpitis focused on measuring Pulpotomy, Mineral Trioxide Aggregate (MTA), Biodentine, Vital pulp therapy, Postoperative pain, Overall success

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Mineral Trioxide Aggregate (MTA)

    Biodentine

    Arm Description

    Outcomes

    Primary Outcome Measures

    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"
    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"
    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"

    Secondary Outcome Measures

    Overall (clinical and radiographic) success after 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.
    Overall (clinical and radiographic) success after 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.

    Full Information

    First Posted
    March 17, 2019
    Last Updated
    March 25, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03890835
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2019 (Anticipated)
    Primary Completion Date
    May 2020 (Anticipated)
    Study Completion Date
    May 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Symptomatic Irreversible Pulpitis
    Keywords
    Pulpotomy, Mineral Trioxide Aggregate (MTA), Biodentine, Vital pulp therapy, Postoperative pain, Overall success

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
    Masking
    Participant
    Masking Description
    The study will be participant-blind where the participant will not know the intervention done.
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mineral Trioxide Aggregate (MTA)
    Arm Type
    Active Comparator
    Arm Title
    Biodentine
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    MTA Pulpotomy.
    Intervention Description
    Pulpotomy using MTA.
    Intervention Type
    Procedure
    Intervention Name(s)
    Biodentine Pulpotomy
    Intervention Description
    Pulpotomy using Biodentine
    Primary Outcome Measure Information:
    Title
    Postoperative pain after 6 hours postoperatively
    Description
    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"
    Time Frame
    6 hours postoperatively
    Title
    Postoperative pain after 12 hours postoperatively
    Description
    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"
    Time Frame
    12 hours postoperatively
    Title
    Postoperative pain after 24 hours postoperatively
    Description
    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"
    Time Frame
    24 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    Overall (clinical and radiographic) success after 6 months postoperatively.
    Description
    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.
    Time Frame
    6 months postoperatively
    Title
    Overall (clinical and radiographic) success after 12 months postoperatively.
    Description
    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.
    Time Frame
    12 months postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Youssef A. Kamal Elalfy, B.D.S
    Phone
    +201286069484
    Email
    Youssef_Andraws@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suzan AW Amin, Ph.D.
    Email
    swaness@rocketmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Youssef A. Kamal Elalfy, B.D.S.
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24771228
    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.
    Results Reference
    background
    PubMed Identifier
    29061359
    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.
    Results Reference
    background
    PubMed Identifier
    28822566
    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.
    Results Reference
    background

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    Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA

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