Evaluation of the Chemo-mechanical Caries Removal Agent (BRIX3000®) in Primary Molars
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

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.
    

Detailed description: 
      Dental caries is one of the most prevalent chronic diseases in people worldwide. It results
      in localized dissolution and destruction of the calcified tooth tissues. The destruction of
      the dental structure does not occur as a result of a localized accumulation of bacteria, but
      rather as a result of an invasive and infectious process caused by the interaction of several
      interconnected factors. These factors make dental caries a great challenge for the dentist,
      as they seek an efficient means to control it. Carious dentin consists of two distinct
      layers: an outer "caries-infected dentin" and an inner "caries-affected". The
      "caries-affected" dentin is described as demineralized inter-tubular dentin, crystal
      deposition in dentinal tubules, and a lesser amount of destructed collagen matrix with no
      bacterial invasion. On the contrary, the "caries-infected" dentin displays deformation of the
      microstructure of the dentinal tubules and permanently damaged collagen fibers with
      significant penetration of the bacteria. Thus, the "caries-infected" dentin has to be removed
      only during caries removal. 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 concept of minimal intervention dentistry (e.g., air abrasion, laser,
      chemo-mechanical caries removal (CMCR) agents) includes the selective removal of
      caries-infected dentin while preserving the healthy caries-affected dentin that has the
      ability to remineralize. It is less destructive and less painful, thereby promoting a
      positive attitude towards visiting dentists among children. Brix Medical Science in 2016
      released a new CMCR agent named "BRIX3000®". It is an enzymatic gel for non-traumatic caries
      removal known with exclusive technology as "Encapsulating Buffer Emulsion" (EPE) that is
      claimed to have superior characteristics for caries removal compared to previous products
      available in the dental market. There are a few studies present in the literature, most of
      them published in non-English language versions, evaluating the clinical and laboratory
      properties of "BRIX3000®". Therefore, investigations were required to evaluate and compare
      the outcomes of "BRIX3000®" versus the previous CMCR agent, "Carie-CareTM" and the
      traditional surgical methods. This study was carried out at King Abdulaziz Dental University
      Hospital (KADUH) and the Microbiology Research Laboratory in the Faculty of Pharmacy, King
      Abdulaziz University, Jeddah, Saudi Arabia to evaluate the efficacy, efficiency, and pain
      experienced by children with the use of the CMCR agents "BRIX3000®" and "Carie-CareTM" versus
      the traditional surgical method in primary molars. The study was approved by the "Research
      Ethics committee" at the Faculty of Dentistry, King Abdulaziz University (KAU) under approval
      number 107-06-19. Informed written consent will be signed by the parents/guardians of the
      children after explaining it to them. The study sample will be consisted of healthy and
      cooperative children aged 4 to 9 years old with bilateral open occlusal carious lesions in
      primary molars who will be seen as outpatients at KADUH's Department of Pediatric Dentistry
      from October 2019 to December 2020.The sample size was measured using G power analysis for
      calculating an estimated sample size. The final sample will be consisted of 60 children aged
      4-9 years with 30 pairs of matched contralateral open occlusal carious lesions in primary
      molars meeting the inclusion criteria. They will be randomly allocated to either group (1) or
      group (2). In group 1, 30 children with 60 primary molars will be subjected to caries removal
      by the CMCR method "BRIX3000®" (the experimental group) on one molar (n = 30) and the
      traditional surgical method (the control group) on the contralateral molar (n = 30). In group
      2, 30 children with 60 primary molars will be subjected to caries removal by the CMCR method
      "Carie-CareTM" (the experimental group) on one molar (n = 30) and the traditional surgical
      method (the control group) on the contralateral molar (n = 30). The block randomization
      method (a block of the two contralateral teeth) will be used to make sure that each side was
      treated evenly by both methods. The statistical assessment will be carried out using the
      Statistical Package for Social Sciences (SPSS, V.20, IBM, NY, USA). A significance level of
      5% was utilized for all analyses.
    

Intervention name(s): The chemomechanical caries removal agent "BRIX3000®" in group (1A); The traditional surgical treatment in group (1C); The chemomechanical caries removal agent "Carie-CareTM" in group (2B); The traditional surgical treatment in group (2C)
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): In group(1A), the chemomechanical caries removal agent "BRIX3000®" was used for caries removal in primary molars.; In group(1C), the traditional surgical method (high-speed and low-speed air-rotors) was used for caries removal in primary molars.; In group(2B), the chemomechanical caries removal agent "Carie-CareTM" was used for caries removal in primary molars.; In group(2C), the traditional surgical method (high-speed and low-speed air-rotors) was used for caries removal in primary molars.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental, two separate randomized controlled groups with split mouth design, following the "Consolidated Standards of Reporting Trials" (CONSORT,2010) statement. The final sample consisted of 60 children who met the inclusion criteria and had contralateral open occlusal carious lesions in their primary molars. They were randomly allocated to either group (1) or group (2). In group 1, 30 children with 60 primary molars underwent caries removal by the CMCR method "BRIX3000®" (the experimental group) on one molar (n = 30) and the traditional surgical method (the control group) on the contralateral molar (n = 30). In group 2, 30 children with 60 primary molars underwent caries removal by the CMCR method "Carie-CareTM" (the experimental group) on one molar (n = 30) and the traditional surgical method (the control group) on the contralateral molar (n = 30).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BRIX3000; Carie-Care; Traditional surgical method; Microbiology; Pain; Primary molars