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

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03408626
• Other study ID #: CEBC-CU-2017-12-28
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: June 1, 2019

Study information

• Verified date: July 2018
• Source: Cairo University
• Contact: laila akml emad eldin elokaly, master
• Phone: 01147604339
• Email: lailaelokaly15[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2
• Est. completion date: June 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Dental Caries
• Infection
• Microbial Colonization

Intervention

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.

Device:
• conventional rotary
traditional rotary method

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)