Microbiological Assessment After Chemo-Mechanical Caries Removal Using Papain-based Enzyme Versus Conventional Rotary Tools in Occlusal Carious Lesions
1 other identifier
interventional
2
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2017
CompletedFirst Posted
Study publicly available on registry
January 24, 2018
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJanuary 31, 2019
July 1, 2018
2 months
December 26, 2017
January 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
at the same visit (20 minutes)
Study Arms (2)
papain chemomechenical caries removal agent (brix 3000)
EXPERIMENTALpapain chemomechenical caries removal agent (Birx 3000) and the exclusive Encapsulating Buffer Emulsifier (EBE) technology claim it has effective and selective proteolytic action
conventional
PLACEBO COMPARATORconventional 330 bur
Interventions
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.
traditional rotary method
Eligibility Criteria
You may qualify if:
- Class I carious lesions
- Lower molars
- Bilateral lesions
- years
- Males or Females (Both genders)
- Good oral hygiene
- Co-operative patients approving the trial
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Teaching assistant
Study Record Dates
First Submitted
December 26, 2017
First Posted
January 24, 2018
Study Start
March 1, 2019
Primary Completion
May 1, 2019
Study Completion
June 1, 2019
Last Updated
January 31, 2019
Record last verified: 2018-07