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

June 16, 2022 updated by: Najlaa Alamoudi, King Abdulaziz University

Clinical and Microbiological Evaluation of the Chemo-mechanical Caries Removal Agent (BRIX3000®) in Primary Molars: A Randomized Controlled Clinical Trial.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Makkah Region
      • Jeddah, Makkah Region, Saudi Arabia, 80209
        • King Abdulaziz University, Dental University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy and cooperative patients of age group 4-9 years.
  • Primary first/second molars with open occlusal carious lesion having moderated depth and clinically visible brownish color softened dentin.
  • No clinical signs or symptoms of pulp degeneration, such as tenderness to percussion and history of sinus tracts or swelling. Intraoral periapical radiographs with lesions having radiolucency extending into, but only confined to dentin.

Exclusion Criteria:

  • Patients with any major and minor systemic illness.
  • Uncooperative patients that necessitate pharmacological dental treatment.
  • Primary molars with mobile teeth, arrested caries, restored teeth, non-vital teeth, no carious lesion, presence of developmental defects and non-restorable teeth.
  • Patients on any antibiotic regimen either on the day of treatment or for at least 2 weeks prior to the study.
  • Patients allergic to Latex.
  • Radiographic evidence of external or internal root resorption, furcal or periapical radiolucency.
  • Primary molars with more than half of the root length resorbed.
  • Children who did not attend and complete the second session of treatment.
  • Not approving to sign the consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group (1A)
30 children with 60 primary molars underwent caries removal by the CMCR method "BRIX3000®" (the experimental group) on one molar (n = 30).
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.
Active Comparator: Group (1C)
30 children with 60 primary molars underwent caries removal by the traditional surgical method (the control group) on the contralateral molar (n = 30).
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.
Experimental: Group (2B)
30 children with 60 primary molars underwent caries removal by the CMCR method "Carie-CareTM" " (the experimental group) on one molar (n = 30).
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.
Active Comparator: Group (2C)
30 children with 60 primary molars underwent caries removal by the traditional surgical method (the control group) on the contralateral molar (n = 30).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The efficacy of caries removal
Time Frame: through study completion, an average of 1 year
A change in the total viable count (TVC) of dentin samples taken during the dental treatment session is being assessed and presented as colony forming unit (CFU) per mL of sample.
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The efficiency of caries removal
Time Frame: through study completion, an average of 1 year
The duration of the caries removal during the dental treatment session was recorded in minutes by a stopwatch.
through study completion, an average of 1 year
The pain perception during caries removal
Time Frame: through study completion, an average of 1 year
The Faces Pain Scale was used to evaluate the pain perception during the procedure of caries removal . The child was asked to choose a face (recorded with a score) matching the intensity of his or her pain experience during the procedure. The scores have a minimum value of 0 and a maximum value of 10. The higher the score, the more painful the procedure is.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King Abdulaziz University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Heba M Elkhodary, D.Sc., King Abdulaziz University
  • Principal Investigator: Najla'a M AL-Amoudi, D.Sc., King Abdulaziz University
  • Study Chair: Manal S Maashi, M.Sc., King Abdulaziz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Manal Maashi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

The data will become available within 18 months starting from 1st July 2019 for unlimited time.

IPD Sharing Access Criteria

Public

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings