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Discoloration of Endosequence and Mineral Trioxde Aggregate in Revascularization of Necrotic Immature Permanent Teeth

Primary Purpose

Pulp Necrosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Revascularization
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Necrosis

Eligibility Criteria

8 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age of patient range from 8-14 y.
  • Patients are free from any systemic diseases that may hinder the normal healing process.
  • Non vital permanent anterior teeth with open apex.
  • Pulp space not needed for post and core for final restoration.
  • Compliant patient/parent.

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Enosequence

    Mineral Trioxide Aggregate

    Arm Description

    3-4 mm of Endosequence will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization

    3-4 mm of Mineral Trioxide Aggregate will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization

    Outcomes

    Primary Outcome Measures

    discoloration
    Asking patient question (Binary:present or absent)
    discoloration
    Asking patient question (Binary:present or absent)
    dicoloration
    Asking patient question (Binary:present or absent)
    discoloration
    Asking patient question (Binary:present or absent)
    discoloration
    Asking patient question (Binary:present or absent)

    Secondary Outcome Measures

    post operative pain
    asking the patient (Binary: present or Absent)
    color stability
    Operator and supervisor evaluation (Using shade guide)
    Pain on percussion
    Assessed by back of the mirror (Binary: present or absent)
    Swelling
    assessed by visual examination (Binary:present or absent)
    Sinus or fistula
    assessed by visual examination (Binary:present or absent)
    Root lengthening
    assessed radiographically (DIGORA® for Windows software)

    Full Information

    First Posted
    January 14, 2019
    Last Updated
    July 18, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03813433
    Brief Title
    Discoloration of Endosequence and Mineral Trioxde Aggregate in Revascularization of Necrotic Immature Permanent Teeth
    Official Title
    Discoloration After Revascularization Using Calcium Phosphosilicate Based Bioceramic vs Mineral Trioxide Aggregate in Necrotic Immature Permanent Anterior Teeth: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    November 2024 (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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    the objective of this study is to evaluate post operative pain after using Endosequence versus Mineral Trioxide Aggregate as coronal plug material in revascularization of non vital immature anterior teeth
    Detailed Description
    The treatment of immature young permanent anterior teeth is challenging because in addition of the need of elimination of bacterial infection; the lack of natural apical constriction against which a suitable filling material can be placed is considered the main problem. In the past many different treatments have been proposed for immature permanent teeth with necrotic pulps such as:Custom fitting of filling materials like gutta percha, Periapical surgeries, apexification. The disadvantages of these treatments are: the compromised Crown/root ratio, possibility of vertical fracture. Pulp revascularization is dependent on the ability of residual pulp and apical and periodontal stem cells to differentiate. These cells have the ability to generate a highly vascularized and rich living tissue. MTA was chosen as coronal seal to be placed over the blood clot due its a biocompatibility, bio-inductivity. However, the disadvantages of MTA are: discoloration of the coronal dentine when placed in the canal and the difficult handling properties. Recently, a new bioceramic material has been introduced to the market, namely, EndoSequence which is bioactive, has antibacterial activity, less cytotoxic effect and similar antimicrobial properties, maintain color stability of the tooth when compared to MTA

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulp Necrosis

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Enosequence
    Arm Type
    Experimental
    Arm Description
    3-4 mm of Endosequence will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization
    Arm Title
    Mineral Trioxide Aggregate
    Arm Type
    Active Comparator
    Arm Description
    3-4 mm of Mineral Trioxide Aggregate will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization
    Intervention Type
    Other
    Intervention Name(s)
    Revascularization
    Other Intervention Name(s)
    pulp regeneration
    Intervention Description
    a procedure used to regenerate pulp dentin complex that restores the functional properties of this immature anterior teeth, prevent and resolves apical periodontitis
    Primary Outcome Measure Information:
    Title
    discoloration
    Description
    Asking patient question (Binary:present or absent)
    Time Frame
    1 month
    Title
    discoloration
    Description
    Asking patient question (Binary:present or absent)
    Time Frame
    3 months
    Title
    dicoloration
    Description
    Asking patient question (Binary:present or absent)
    Time Frame
    6 months
    Title
    discoloration
    Description
    Asking patient question (Binary:present or absent)
    Time Frame
    9 months
    Title
    discoloration
    Description
    Asking patient question (Binary:present or absent)
    Time Frame
    12months
    Secondary Outcome Measure Information:
    Title
    post operative pain
    Description
    asking the patient (Binary: present or Absent)
    Time Frame
    1,3, 6, 9 and 12 months
    Title
    color stability
    Description
    Operator and supervisor evaluation (Using shade guide)
    Time Frame
    1,3, 6, 9 and 12 months
    Title
    Pain on percussion
    Description
    Assessed by back of the mirror (Binary: present or absent)
    Time Frame
    1,3, 6, 9 and 12 months
    Title
    Swelling
    Description
    assessed by visual examination (Binary:present or absent)
    Time Frame
    1,3, 6, 9 and 12 months
    Title
    Sinus or fistula
    Description
    assessed by visual examination (Binary:present or absent)
    Time Frame
    1,3, 6, 9 and 12 months
    Title
    Root lengthening
    Description
    assessed radiographically (DIGORA® for Windows software)
    Time Frame
    6 and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age of patient range from 8-14 y. Patients are free from any systemic diseases that may hinder the normal healing process. Non vital permanent anterior teeth with open apex. Pulp space not needed for post and core for final restoration. Compliant patient/parent. Exclusion Criteria: Patients having allergy to medicaments and antibiotics necessary to complete the procedure. Tooth with vital pulp or complete root formation. Teeth with internal or external root resorption. Un-cooperative patients

    12. IPD Sharing Statement

    Learn more about this trial

    Discoloration of Endosequence and Mineral Trioxde Aggregate in Revascularization of Necrotic Immature Permanent Teeth

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