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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-06-01

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

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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

Conditions

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Microbial Colonization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Papain-based Chemo-mechanical caries removal agent

Intervention Type DRUG

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.

conventional rotary

Intervention Type DEVICE

traditional rotary method

conventional

conventional 330 bur

Group Type PLACEBO_COMPARATOR

Papain-based Chemo-mechanical caries removal agent

Intervention Type DRUG

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.

conventional rotary

Intervention Type DEVICE

traditional rotary method

Interventions

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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.

Intervention Type DRUG

conventional rotary

traditional rotary method

Intervention Type DEVICE

Other Intervention Names

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Brix 3000 round bur 330

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes