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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03408626

Enrollment

Registered

2018-01-24

Start date

2019-03-01

Completion date

2019-06-01

Last updated

2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbial Colonization

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

Interventions

DRUGPapain-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.

DEVICEconventional rotary

traditional rotary method

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Contacts

Primary Contactlaila akml emad eldin elokaly, master

lailaelokaly15@gmail.com01147604339

Backup Contactlaila akmal emad eldin elokaly, master