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

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

Study Overview

• Status: Unknown
• Conditions: Microbial Colonization
• Intervention / Treatment: Drug: Papain-based Chemo-mechanical caries removal agent; Device: conventional rotary

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 Type: Interventional
• Enrollment (Anticipated): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: laila akml emad eldin elokaly, master; Phone Number: 0223806159 01147604339; Email: lailaelokaly15@gmail.com
• Study Contact Backup: Name: laila akmal emad eldin elokaly, master; Phone Number: 0223806159 01147604339; Email: lailaelokaly15@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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.; Other Names: Brix 3000; Device: conventional rotary; traditional rotary method; Other Names: round bur 330
Placebo Comparator: conventional; conventional 330 bur	Drug: 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.; Other Names: Brix 3000; Device: conventional rotary; traditional rotary method; Other Names: round bur 330

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Infections; Communicable Diseases; Dental Caries
• Other Study ID Numbers: CEBC-CU-2017-12-28

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No