Evaluation of the Chemo-mechanical Caries Removal Agent (BRIX3000®) in Primary Molars

Summary

Dental caries is one of the most prevalent chronic diseases in people worldwide. Traditional clinical treatment of dental decay has developed on the basis of the removal of carious tissues with high-speed handpieces and slow-rotating instruments, inducing pain, disturbing sounds, and vibrations. In addition, this method comprises the tooth structure by removing both "caries-affected dentin" and "caries-infected dentin". The use of the chemo-mechanical caries removal (CMCR) method is one of the main implementations of the minimal intervention dentistry idea accepted in the last ten years. It includes the selective removal of "caries-infected dentin" while preserving the healthy "caries-affected dentin" that has the ability to remineralize. The CMCR method differs from the traditional surgical method in that it selectively removes carious dentin. Therefore, it is less destructive and less painful, thereby promoting a positive attitude towards visiting dentists. A novel agent for the CMCR method named "BRIX3000®" by the laboratory Brix Medical Science has been released onto the dental market in 2016. It is a papain-based gel derived from latex and fruits of green papaya (Carica Papaya) that works as a chemical debridement with a unique technology called Encapsulating Buffer Emulsion (EPE). Investigations are required to evaluate and compare the outcomes of two CMCR agents, "BRIX3000®" and "Carie-CareTM," versus the traditional surgical methods. Therefore, the present study aims to perform a clinical and microbiological evaluation of caries removal using "BRIX3000®" and "Carie-CareTM" versus the traditional surgical methods in primary molars among children in Jeddah city, Saudi Arabia.

Conditions

• Dental Caries

Interventions

PROCEDURE

The chemomechanical caries removal agent "BRIX3000®" in group (1A)

In group(1A), the chemomechanical caries removal agent "BRIX3000®" was used for caries removal in primary molars.

PROCEDURE

The traditional surgical treatment in group (1C)

In group(1C), the traditional surgical method (high-speed and low-speed air-rotors) was used for caries removal in primary molars.

PROCEDURE

The chemomechanical caries removal agent "Carie-CareTM" in group (2B)

In group(2B), the chemomechanical caries removal agent "Carie-CareTM" was used for caries removal in primary molars.

PROCEDURE

The traditional surgical treatment in group (2C)

In group(2C), the traditional surgical method (high-speed and low-speed air-rotors) was used for caries removal in primary molars.

Sponsors & Collaborators

• King Abdulaziz University

  lead OTHER

Principal Investigators

• Heba M Elkhodary, D.Sc. · King Abdulaziz University

• Najla'a M AL-Amoudi, D.Sc. · King Abdulaziz University

• Manal S Maashi, M.Sc. · King Abdulaziz University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-10-01

Primary Completion

2020-12-30

Completion

2021-01-01

Countries

• Saudi Arabia

Study Locations