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Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Anterior Teeth

Primary Purpose

Pulp Necrosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biodentine
Mineral Trioxide Aggregate
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Necrosis focused on measuring revascularization, necrotic, immature, coronal plug

Eligibility Criteria

8 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients free from any systemic diseases that may hinder the normal healing process.
  • Age from 8-15 y
  • Tooth with immature root apex (apical opening greater than 1mm)
  • Traumatically or cariously exposed single rooted teeth
  • Non vital permanent anterior tooth with apical periodontitis/abscess
  • Pulp space not requiring post and core for final restoration.

Exclusion Criteria:

  • Patients having allergy to medicaments or antibiotics necessary to complete procedure.
  • Tooth with vital pulp or complete root formation.
  • Teeth with internal or external root resorption.
  • Un-cooperative patient

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Biodentine

    Mineral Trioxide Aggregate

    Arm Description

    3-4 mm of Biodentine (Septodont, St. Maur-des-Fosses, France) was applied over the clot carefully in group I by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization.

    3-4 mm of white Mineral Trioxide Aggregate (Angelus, Londrina, Brazil) was applied over the clot in group II by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization.

    Outcomes

    Primary Outcome Measures

    pain on biting
    Binary outcome (Present or absent). Assessed by asking the patient
    pain on biting
    Binary outcome (Present or absent). Assessed by asking the patient
    pain on biting
    Binary outcome (Present or absent). Assessed by asking the patient
    pain on biting
    Binary outcome (Present or absent). Assessed by asking the patient

    Secondary Outcome Measures

    pain on percussion
    Binary outcome (Present or absent). Assessed by tapping the tooth with the back of the mirror
    swelling
    Binary outcome (Present or absent). Assessed by visual examination of labial vestibule
    mobility
    Binary outcome (Present or absent). Assessed by applying pressure with the ends of 2 metal instruments
    Sinus or fistula
    Binary outcome (Present or absent). Assessed by visual examination of labial vestibule
    crown discoloration
    Binary outcome (Present or absent). Assessed by visual examination of the crown
    root lengthening
    Evaluated radiographically using DIGORA software.Unit of measurements were mm
    root lengthening
    Evaluated radiographically using DIGORA software.Unit of measurements were percent

    Full Information

    First Posted
    June 24, 2018
    Last Updated
    July 5, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03589560
    Brief Title
    Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Anterior Teeth
    Official Title
    Clinical and Radiographic Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Permanent Anterior Teeth (Randomized Clinical Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 15, 2015 (Actual)
    Primary Completion Date
    August 15, 2017 (Actual)
    Study Completion Date
    January 15, 2018 (Actual)

    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 object of this study is to evaluate clinically and radiographically the effect of using Biodentine and Mineral Trioxide Aggregate as coronal plug materials in revascularization of non-vital immature teeth
    Detailed Description
    Traumatic injury to the anterior teeth is commonly found among young children, represent one third in boys and one fourth in girls. Because the root development completed two years after eruption of the tooth into the oral cavity, an incomplete root development is one of the most common complication seen in traumatized teeth. Loss of pulp vitality before dentine deposition is completed, leaves a weak root more susceptible to fracture as a result of the thin dentinal walls. It will also lead to a poor crown/root ratio, with possible periodontal injury as a result of increased mobility. Several techniques have been advocated to manage the open apex of immature teeth, including calcium hydroxide (Ca(OH)2) apexification or apical barrier technique with Mineral Trioxide Aggregate (MTA). Although these techniques were successful in obtaining apical closure and healing of the apical pathosis, they have certain disadvantages, as the root walls of the immature tooth remain thin and short as hard tissue barrier formation only occurs apically, with no further root development. As an replacement to traditional methods, the use of a regenerative endodontic procedure has been recommended as it may strengthen the root walls through the deposition of hard tissue and promote the development of a normal apical morphology. MTA was chosen to be placed over blood clot to provide excellent seal and it was considered the recommended material for regenerative procedures.The application of MTA over a blood clot was technically difficult, and condensation resulted in displacement of the material apically. Another important note was the prolonged setting time of MTA which resulted in postponing placement of composite restoration to next appointments and post-treatment tooth discoloration. Biodentine has the same mechanical properties as human dentine, very low cytotoxicity and overcome clinical drawbacks of white MTA. It had better consistency and allow its condensation without any apical displacement. Biodentine sets within twelve minutes, which allow placement of composite restoration in the same appointment. Biodentine is tooth-colored and doesn't cause the discoloration resulted from the presence of the material at level of the orifice.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulp Necrosis
    Keywords
    revascularization, necrotic, immature, coronal plug

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Biodentine
    Arm Type
    Experimental
    Arm Description
    3-4 mm of Biodentine (Septodont, St. Maur-des-Fosses, France) was applied over the clot carefully in group I by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization.
    Arm Title
    Mineral Trioxide Aggregate
    Arm Type
    Active Comparator
    Arm Description
    3-4 mm of white Mineral Trioxide Aggregate (Angelus, Londrina, Brazil) was applied over the clot in group II by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization.
    Intervention Type
    Drug
    Intervention Name(s)
    Biodentine
    Other Intervention Name(s)
    Dentine substitute material
    Intervention Description
    a procedure used to regenerate a pulp-dentine complex that restores functional properties of this tissue, fosters continued root development for immature teeth, and prevents or resolves apical periodontitis.
    Intervention Type
    Drug
    Intervention Name(s)
    Mineral Trioxide Aggregate
    Other Intervention Name(s)
    MTA
    Intervention Description
    a procedure used to regenerate a pulp-dentine complex that restores functional properties of this tissue, fosters continued root development for immature teeth, and prevents or resolves apical periodontitis.
    Primary Outcome Measure Information:
    Title
    pain on biting
    Description
    Binary outcome (Present or absent). Assessed by asking the patient
    Time Frame
    3 months
    Title
    pain on biting
    Description
    Binary outcome (Present or absent). Assessed by asking the patient
    Time Frame
    6 months
    Title
    pain on biting
    Description
    Binary outcome (Present or absent). Assessed by asking the patient
    Time Frame
    9 months
    Title
    pain on biting
    Description
    Binary outcome (Present or absent). Assessed by asking the patient
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    pain on percussion
    Description
    Binary outcome (Present or absent). Assessed by tapping the tooth with the back of the mirror
    Time Frame
    3, 6, 9, 12 month
    Title
    swelling
    Description
    Binary outcome (Present or absent). Assessed by visual examination of labial vestibule
    Time Frame
    3, 6, 9, 12 month
    Title
    mobility
    Description
    Binary outcome (Present or absent). Assessed by applying pressure with the ends of 2 metal instruments
    Time Frame
    3, 6, 9, 12 month
    Title
    Sinus or fistula
    Description
    Binary outcome (Present or absent). Assessed by visual examination of labial vestibule
    Time Frame
    3, 6, 9, 12 month
    Title
    crown discoloration
    Description
    Binary outcome (Present or absent). Assessed by visual examination of the crown
    Time Frame
    3, 6, 9, 12 month
    Title
    root lengthening
    Description
    Evaluated radiographically using DIGORA software.Unit of measurements were mm
    Time Frame
    3, 6, 9, 12 month
    Title
    root lengthening
    Description
    Evaluated radiographically using DIGORA software.Unit of measurements were percent
    Time Frame
    3, 6, 9, 12 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients free from any systemic diseases that may hinder the normal healing process. Age from 8-15 y Tooth with immature root apex (apical opening greater than 1mm) Traumatically or cariously exposed single rooted teeth Non vital permanent anterior tooth with apical periodontitis/abscess Pulp space not requiring post and core for final restoration. Exclusion Criteria: Patients having allergy to medicaments or antibiotics necessary to complete procedure. Tooth with vital pulp or complete root formation. Teeth with internal or external root resorption. Un-cooperative patient
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Randa Youssef, PHD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Anterior Teeth

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