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Microbiological Assessment After Chemo-Mechanical Caries Removal Using Papain-based Enzyme Versus Conventional Rotary Tools in Occlusal Carious Lesions

Primary Purpose

Microbial Colonization

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Papain-based Chemo-mechanical caries removal agent
conventional rotary
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microbial Colonization

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Class I carious lesions
  2. Lower molars
  3. Bilateral lesions
  4. 18 -50 years
  5. Males or Females (Both genders)
  6. Good oral hygiene
  7. Co-operative patients approving the trial

Exclusion Criteria:

  1. Pregnancy
  2. Systemic disease or severe medical complications
  3. Periodontal problem
  4. Mobile teeth, arrest caries and non-vital teeth
  5. Smokers
  6. Xerostomia
  7. Lack of compliance
  8. Not received antibiotic therapy since 1 month before sampling

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    papain chemomechenical caries removal agent (brix 3000)

    conventional

    Arm Description

    papain chemomechenical caries removal agent (Birx 3000) and the exclusive Encapsulating Buffer Emulsifier (EBE) technology claim it has effective and selective proteolytic action

    conventional 330 bur

    Outcomes

    Primary Outcome Measures

    bacterial count by Digital Colony Counter
    The number of colonies will be expressed as colony-forming units (CFU/ml) compared before and after removal caries using brix 3000 or rotary method

    Secondary Outcome Measures

    Full Information

    First Posted
    December 26, 2017
    Last Updated
    January 29, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03408626
    Brief Title
    Microbiological Assessment After Chemo-Mechanical Caries Removal Using Papain-based Enzyme Versus Conventional Rotary Tools in Occlusal Carious Lesions
    Official Title
    Microbiological Assessment After Chemo-Mechanical Caries Removal Using Papain-based Enzyme Versus Conventional Rotary Tools in Occlusal Carious Lesions: Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2019 (Anticipated)
    Primary Completion Date
    May 1, 2019 (Anticipated)
    Study Completion Date
    June 1, 2019 (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
    This study will be conducted to assess the efficacy of caries excavation using the papain-based chemo-mechanical method (Brix 3000) in comparison to conventional rotary tools in the reduction of the bacterial population in occlusal carious cavities
    Detailed Description
    Twenty-three patients who will fulfill the inclusion criteria will be enrolled to the study. For every patient two contra-lateral class I carious molars will be selected, so the total number of included molars will be 46 molars. One contra-lateral molar will be randomly assigned to the chemo-mechanical (Brix 3000) caries removal technique and the other will be assigned to the conventional rotary one. From every molar two dentin specimens will be collected (baseline and after excavation) with a total of 92 samples

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Microbial Colonization

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    papain chemomechenical caries removal agent (brix 3000)
    Arm Type
    Experimental
    Arm Description
    papain chemomechenical caries removal agent (Birx 3000) and the exclusive Encapsulating Buffer Emulsifier (EBE) technology claim it has effective and selective proteolytic action
    Arm Title
    conventional
    Arm Type
    Placebo Comparator
    Arm Description
    conventional 330 bur
    Intervention Type
    Drug
    Intervention Name(s)
    Papain-based Chemo-mechanical caries removal agent
    Other Intervention Name(s)
    Brix 3000
    Intervention Description
    Birx 3000 and the exclusive Encapsulating Buffer Emulsifier (EBE) technology claim it has effective and selective proteolytic action to remove collagen fiber in the carious tissue. It has an antibacterial and antifungal power, thus it has an antiseptic power at the tissue level .furthermore, this gel does not contain chloramines in its formula, which enhances its toxicological safety feature.
    Intervention Type
    Device
    Intervention Name(s)
    conventional rotary
    Other Intervention Name(s)
    round bur 330
    Intervention Description
    traditional rotary method
    Primary Outcome Measure Information:
    Title
    bacterial count by Digital Colony Counter
    Description
    The number of colonies will be expressed as colony-forming units (CFU/ml) compared before and after removal caries using brix 3000 or rotary method
    Time Frame
    at the same visit (20 minutes)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Class I carious lesions Lower molars Bilateral lesions 18 -50 years Males or Females (Both genders) Good oral hygiene Co-operative patients approving the trial Exclusion Criteria: Pregnancy Systemic disease or severe medical complications Periodontal problem Mobile teeth, arrest caries and non-vital teeth Smokers Xerostomia Lack of compliance Not received antibiotic therapy since 1 month before sampling
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    laila akml emad eldin elokaly, master
    Phone
    01147604339
    Ext
    0223806159
    Email
    lailaelokaly15@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    laila akmal emad eldin elokaly, master
    Phone
    01147604339
    Ext
    0223806159
    Email
    lailaelokaly15@gmail.com

    12. IPD Sharing Statement

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    Microbiological Assessment After Chemo-Mechanical Caries Removal Using Papain-based Enzyme Versus Conventional Rotary Tools in Occlusal Carious Lesions

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