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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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ClinicalTrials.gov Identifier: NCT03408626
Recruitment Status : Unknown
Verified July 2018 by Laila Akmal Emad Eldien Elokaly, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : January 24, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Laila Akmal Emad Eldien Elokaly, Cairo University

Study Description
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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

Condition or disease Intervention/treatment Phase
Microbial Colonization Drug: Papain-based Chemo-mechanical caries removal agent Device: conventional rotary Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Microbiological Assessment After Chemo-Mechanical Caries Removal Using Papain-based Enzyme Versus Conventional Rotary Tools in Occlusal Carious Lesions: Randomized Controlled Trial
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arms and Interventions
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Arm Intervention/treatment
Experimental: papain chemomechenical caries removal agent (brix 3000)
papain chemomechenical caries removal agent (Birx 3000) and the exclusive Encapsulating Buffer Emulsifier (EBE) technology claim it has effective and selective proteolytic action
 Drug: Papain-based Chemo-mechanical caries removal agent
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.
Other Name: Brix 3000

Device: conventional rotary
traditional rotary method
Other Name: round bur 330
Placebo Comparator: conventional
conventional 330 bur
 Drug: Papain-based Chemo-mechanical caries removal agent
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.
Other Name: Brix 3000

Device: conventional rotary
traditional rotary method
Other Name: round bur 330


Outcome Measures
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Primary Outcome Measures :
  1. bacterial count by Digital Colony Counter [ Time Frame: at the same visit (20 minutes) ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408626


Contacts
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Contact: laila akml emad eldin elokaly, master 01147604339 ext 0223806159 lailaelokaly15@gmail.com
Contact: laila akmal emad eldin elokaly, master 01147604339 ext 0223806159 lailaelokaly15@gmail.com

Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Laila Akmal Emad Eldien Elokaly, Teaching assistant, Cairo University
ClinicalTrials.gov Identifier: NCT03408626    
Other Study ID Numbers: CEBC-CU-2017-12-28
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Dental Caries
Disease Attributes
 Pathologic Processes
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases