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

NCT05427591 | Completed

• 1 other identifier: Manal Maashi
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

BRIX3000; Carie-Care; Traditional surgical method; Microbiology; Pain; Primary molars

Outcome Measures

Primary Outcomes (1)

• The efficacy of caries removal

  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 Outcomes (2)

• The efficiency of caries removal

  through study completion, an average of 1 year

• The pain perception during caries removal

  through study completion, an average of 1 year

Study Arms (4)

Group (1A)

EXPERIMENTAL

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)

Group (1C)

ACTIVE COMPARATOR

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)

Group (2B)

EXPERIMENTAL

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)

Group (2C)

ACTIVE COMPARATOR

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)

Interventions

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

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

Group (1A)

The traditional surgical treatment in group (1C) PROCEDURE

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

Group (1C)

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

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

Group (2B)

The traditional surgical treatment in group (2C) PROCEDURE

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

Group (2C)

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University, Dental University Hospital

Jeddah, Mecca Region, 80209, Saudi Arabia

Location

Related Publications (1)

• Maashi M, Elkhodary H, Bamashmous N, Felemban O, Alamoudi N. Clinical performance of two chemomechanical caries removal agents in primary molars: a randomized controlled trial. Eur Arch Paediatr Dent. 2025 Aug;26(4):731-739. doi: 10.1007/s40368-025-01030-9. Epub 2025 Apr 9.

  PMID: 40205159 DERIVED

MeSH Terms

Conditions

Dental Caries; Pain

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Heba M Elkhodary, D.Sc.

  King Abdulaziz University

  STUDY DIRECTOR

• Najla'a M AL-Amoudi, D.Sc.

  King Abdulaziz University

  PRINCIPAL INVESTIGATOR

• Manal S Maashi, M.Sc.

  King Abdulaziz University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: 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).

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 22, 2022
• Study Start: October 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: January 1, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available within 18 months starting from 1st July 2019 for unlimited time.
• Access Criteria: Public

Locations

SA (1)