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

Study Overview
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Brief Summary
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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
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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

Official Title
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Microbiological Assessment After Chemo-Mechanical Caries Removal Using Papain-based Enzyme Versus Conventional Rotary Tools in Occlusal Carious Lesions: Randomized Controlled Trial

Conditions
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Microbial Colonization

Intervention / Treatment
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* Drug: Papain-based Chemo-mechanical caries removal agent
* Device: conventional rotary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: papain chemomechenical caries removal agent (brix 3000)<br>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<br>* 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.<br>* Other names: Brix 3000;Device: conventional rotary<br>* traditional rotary method<br>* Other names: round bur 330;|
| Placebo Comparator: conventional<br>conventional 330 bur | Drug: Papain-based Chemo-mechanical caries removal agent<br>* 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.<br>* Other names: Brix 3000;Device: conventional rotary<br>* traditional rotary method<br>* Other names: round bur 330;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |