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

Not Applicable

• Conditions: Microbial Colonization
• Interventions: Drug: Papain-based Chemo-mechanical caries removal agent; Device: conventional rotary

• Registration Number: NCT03408626
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-24
• Status Verified: 2018-07
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31
• Study Start: 2019-03-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
papain chemomechenical caries removal agent (brix 3000)	Papain-based Chemo-mechanical caries removal agent	papain chemomechenical caries removal agent (Birx 3000) and the exclusive Encapsulating Buffer Emulsifier (EBE) technology claim it has effective and selective proteolytic action
papain chemomechenical caries removal agent (brix 3000)	conventional rotary	papain chemomechenical caries removal agent (Birx 3000) and the exclusive Encapsulating Buffer Emulsifier (EBE) technology claim it has effective and selective proteolytic action
conventional	Papain-based Chemo-mechanical caries removal agent	conventional 330 bur
conventional	conventional rotary	conventional 330 bur

Primary Outcome Measures

Name	Time	Method
bacterial count by Digital Colony Counter	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