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Applicability Clinic of Cement Portland Structural White in Endodontic Surgery

Primary Purpose

Mandibular Hypoplasia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ENDODONTIC SURGERY
Sponsored by
Universidade do Vale do Sapucai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandibular Hypoplasia focused on measuring Apicoectomy, Oral surgery, Biocompatible materials, Dental Cements, Translational Medical Research

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients were diagnosed by computed tomography CT, cone beam
  • each of them had from two to four compromised teeth

Exclusion Criteria:

  • patients who did not return for review after six months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    TOOTH ENDODONTIC SURGERY - PBEA

    TOOTH ENDODONTIC SURGERY -MTA

    Arm Description

    Endodontic surgery 15 teeth - PBEA

    Endodontic surgery 15 teeth - MTA

    Outcomes

    Primary Outcome Measures

    Regeneration measured by tomographers endodontic surgery
    Six months after surgery, there were new scans to evaluate the repair or not the wounds.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2015
    Last Updated
    June 17, 2015
    Sponsor
    Universidade do Vale do Sapucai
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02474615
    Brief Title
    Applicability Clinic of Cement Portland Structural White in Endodontic Surgery
    Official Title
    Applicability Clinic of Cement Portland Structural White in Endodontic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade do Vale do Sapucai

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Thirty teeth twelve patients, two female and a male, who had persistent periradicular lesions were selected to participate in this study. The lesions were diagnosed with cone-beam computed tomography (cone-beam CT; Model i-Cat 17-19, Imaging Sciences International LLC).In patients with two teeth to be treated, a tooth was retroobturado with PBEA cement, (experiment) and another tooth was retroobturado with MTA cement (control). There was significance for the two cements on the repair of wounds. Key words: Apicoectomy; Oral Surgery; Biocompatible Materials; Dental Cements; Translational Medical Research
    Detailed Description
    Objective: to evaluate the clinical applicability of structural Portland white cement additive in retrofilling surgeries. Method: persistent apical periodontitis 30 teeth of 12 patients were diagnosed by computed tomography CT, cone beam. Each of them had from two to four compromised teeth. The endodontic surgery were performed and the teeth were retrofilling Each patient had a retrofilling tooth with cement mineral trioxide aggregate (MTA) control and other tooth with white Portland cement structural additive (PBEA) experiment. When the patient presented four teeth with injury, two were retrofilling with MTA and two Portland cement with structural white cement additive. Six months after surgery, there were new scans to evaluate the repair or not the wounds.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mandibular Hypoplasia
    Keywords
    Apicoectomy, Oral surgery, Biocompatible materials, Dental Cements, Translational Medical Research

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TOOTH ENDODONTIC SURGERY - PBEA
    Arm Type
    Experimental
    Arm Description
    Endodontic surgery 15 teeth - PBEA
    Arm Title
    TOOTH ENDODONTIC SURGERY -MTA
    Arm Type
    Experimental
    Arm Description
    Endodontic surgery 15 teeth - MTA
    Intervention Type
    Procedure
    Intervention Name(s)
    ENDODONTIC SURGERY
    Intervention Description
    ENDODONTIC SURGERY
    Primary Outcome Measure Information:
    Title
    Regeneration measured by tomographers endodontic surgery
    Description
    Six months after surgery, there were new scans to evaluate the repair or not the wounds.
    Time Frame
    Six months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients were diagnosed by computed tomography CT, cone beam each of them had from two to four compromised teeth Exclusion Criteria: patients who did not return for review after six months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniela Francescato Veiga
    Organizational Affiliation
    BRAZIL, UNIVAS
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25714696
    Citation
    da Silva SR, da Silva Neto JD, Veiga DF, Schnaider TB, Ferreira LM. Portland cement versus MTA as a root-end filling material. A pilot study. Acta Cir Bras. 2015 Feb;30(2):160-4. doi: 10.1590/S0102-865020150020000011.
    Results Reference
    background
    PubMed Identifier
    23117614
    Citation
    Silva Neto JD, Schnaider TB, Gragnani A, Paiva AP, Novo NF, Ferreira LM. Portland cement with additives in the repair of furcation perforations in dogs. Acta Cir Bras. 2012 Nov;27(11):809-14. doi: 10.1590/s0102-86502012001100011.
    Results Reference
    result
    PubMed Identifier
    20443823
    Citation
    Feldman AM. Does academic culture support translational research? Clin Transl Sci. 2008 Sep;1(2):87-8. doi: 10.1111/j.1752-8062.2008.00046.x. No abstract available.
    Results Reference
    result
    PubMed Identifier
    21120277
    Citation
    Silva Neto JD, Brito RH, Schnaider TB, Gragnani A, Engelman M, Ferreira LM. Root perforations treatment using mineral trioxide aggregate and Portland cements. Acta Cir Bras. 2010 Dec;25(6):479-84. doi: 10.1590/s0102-86502010000600004.
    Results Reference
    result

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    Applicability Clinic of Cement Portland Structural White in Endodontic Surgery

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