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Pulp Revascularization Versus MTA Apexification (RCT)

Primary Purpose

Necrotic Pulp

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
revascularization
Apexification
Sponsored by
Enas Ebrahim Sayed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotic Pulp focused on measuring regeneration, MTA apexification and TAP, revascularization

Eligibility Criteria

7 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Medically-free patients having immature necrotic anterior teeth (with or without apical periodontitis/abscess) even with previous intervention.

Exclusion Criteria:

  • History of allergy to any of the antibiotics in the tri-mix used in the study
  • Patients with systemic diseases e.g. Diabetes mellitus, bleeding disorders,…
  • Psychological disturbance
  • External / internal root resorption or cystic lesion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Revascularization

    Apexfication

    Arm Description

    Blood clot initiation and grey MTA ( Mineral Tri-oxide Aggregate) cervically compacted.

    Apexification using grey MTA apically compacted without mechanical preparation.

    Outcomes

    Primary Outcome Measures

    Pain intensity measures
    self reported pain intesity at 4, 12, 24, and 48 hours.(0= no pain and 100=worst pain) with a scale from 0 to 100 after the two visits.

    Secondary Outcome Measures

    Resolution of periapical pathosis
    Radiographically: by comparing radiolucencies in 9 months postoperative radiograph to the baseline radiograph.
    Amount of radiographic increase in root length:
    Root length was measured as a straight line from the cement-enamel junction to the radiographic apex of the tooth in millimeters = (9months follow up length - baseline length)
    Amount of radiographic increase in the root dentinal wall thickness:
    Dentin thickness was measured by =root thickness-pulp space and compared to the baseline radiograph measurements.
    Decrease of apical diameter:
    the diameter of the apical foramen was measured in millimeters and compared to the baseline radiograph measurements

    Full Information

    First Posted
    March 7, 2017
    Last Updated
    March 19, 2017
    Sponsor
    Enas Ebrahim Sayed
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03083015
    Brief Title
    Pulp Revascularization Versus MTA Apexification
    Acronym
    RCT
    Official Title
    A Comparative Study Between Pulp Revascularization and MTA Apexification in Necrotic Immature Anterior Teeth, A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 6, 2012 (Actual)
    Primary Completion Date
    December 2, 2015 (Actual)
    Study Completion Date
    December 2, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Enas Ebrahim Sayed

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study compared the efficiency of pulp revascularization and MTA apexification in the treatment of patients with necrotic immature anterior teeth.
    Detailed Description
    the participants with 66 anterior necrotic immature teeth were randomly assigned into two equal groups with 33 teeth per each, according to regeneration and MTA apexification. At the first visit, all teeth were accessed and irrigated with NaOCl then a TAP was applied as intra-appointment intracanal medication. At the second visit, after removal of the medication with the irrigation, bleeding was initiated into the canal and isolated by the MTA in the orifice in the regeneration group. While in the Apexification group, the MTA was packed apically and all teeth were finally restored with resin composite restorations. The patients were recalled after 1, 3, 6, and 9 months for clinical and radiographic follow up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Necrotic Pulp
    Keywords
    regeneration, MTA apexification and TAP, revascularization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    participants are allocated at random to receive one of two interventions according to the research plan. In RCT the outcomes are measured, so it is considered a quantitative study . This trial conforms to the Consolidated Standard of Reporting Trials (CONSORT)statement.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    For the allocation concealment mechanism, each of 66 papers (each paper was eight folded) numbered from 1 to 66 were, individually packed, in opaque envelopes. Each participant picked an envelope at the beginning of the second visit. The number in the envelope determined which procedure was to be performed for the patient. The partner was to decide the procedure for the operator according to that number.
    Allocation
    Randomized
    Enrollment
    66 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Revascularization
    Arm Type
    Experimental
    Arm Description
    Blood clot initiation and grey MTA ( Mineral Tri-oxide Aggregate) cervically compacted.
    Arm Title
    Apexfication
    Arm Type
    Active Comparator
    Arm Description
    Apexification using grey MTA apically compacted without mechanical preparation.
    Intervention Type
    Procedure
    Intervention Name(s)
    revascularization
    Other Intervention Name(s)
    regeneration
    Intervention Description
    a sterile sharp needle was used to irritate the apical tissue until bleeding occurred apically in the root canal space so as to create a biological scaffold for the regenerative process
    Intervention Type
    Procedure
    Intervention Name(s)
    Apexification
    Intervention Description
    a 3-5 mm thickness of MTA using a hand plugger and was verified radiographically.
    Primary Outcome Measure Information:
    Title
    Pain intensity measures
    Description
    self reported pain intesity at 4, 12, 24, and 48 hours.(0= no pain and 100=worst pain) with a scale from 0 to 100 after the two visits.
    Time Frame
    2 days
    Secondary Outcome Measure Information:
    Title
    Resolution of periapical pathosis
    Description
    Radiographically: by comparing radiolucencies in 9 months postoperative radiograph to the baseline radiograph.
    Time Frame
    9 months
    Title
    Amount of radiographic increase in root length:
    Description
    Root length was measured as a straight line from the cement-enamel junction to the radiographic apex of the tooth in millimeters = (9months follow up length - baseline length)
    Time Frame
    baseline and 9 months
    Title
    Amount of radiographic increase in the root dentinal wall thickness:
    Description
    Dentin thickness was measured by =root thickness-pulp space and compared to the baseline radiograph measurements.
    Time Frame
    baseline and 9 months
    Title
    Decrease of apical diameter:
    Description
    the diameter of the apical foramen was measured in millimeters and compared to the baseline radiograph measurements
    Time Frame
    baseline and 9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Medically-free patients having immature necrotic anterior teeth (with or without apical periodontitis/abscess) even with previous intervention. Exclusion Criteria: History of allergy to any of the antibiotics in the tri-mix used in the study Patients with systemic diseases e.g. Diabetes mellitus, bleeding disorders,… Psychological disturbance External / internal root resorption or cystic lesion.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ahmed alkhadem, lecturer
    Organizational Affiliation
    evidence based center, Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25443280
    Citation
    Saoud TM, Zaazou A, Nabil A, Moussa S, Lin LM, Gibbs JL. Clinical and radiographic outcomes of traumatized immature permanent necrotic teeth after revascularization/revitalization therapy. J Endod. 2014 Dec;40(12):1946-52. doi: 10.1016/j.joen.2014.08.023. Epub 2014 Oct 16.
    Results Reference
    result
    PubMed Identifier
    25069909
    Citation
    Alobaid AS, Cortes LM, Lo J, Nguyen TT, Albert J, Abu-Melha AS, Lin LM, Gibbs JL. Radiographic and clinical outcomes of the treatment of immature permanent teeth by revascularization or apexification: a pilot retrospective cohort study. J Endod. 2014 Aug;40(8):1063-70. doi: 10.1016/j.joen.2014.02.016. Epub 2014 Jun 13.
    Results Reference
    result
    Links:
    URL
    http://dx.doi.org/10.1016/j.joen.2014.08.023
    Description
    test link
    URL
    http://dx.doi.org/10.1016/j.joen.2014.02.016
    Description
    test link

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