Clinical Evaluation and Antimicrobial Effect of Papain Based Chemo-mechanical Caries Removal Agents
1 other identifier
interventional
108
1 country
1
Brief Summary
Minimally invasive dentistry continues to gain importance, especially in the treatment of permanent teeth with deep caries lesions and immature roots. Chemo-mechanical caries removal (CMCR) is an alternative to the conventional method and consists of the application of a proteolytic substance that softens carious dentin tissue and facilitates its removal using manual instruments. This method can be employed without the use of local anesthesia or burs, thereby preserving sound dental tissue. The trial aim to assess the clinical performance of Brix 3ooo and Papacarie duo gel as chemo-mechanical caries removal agents (CMCR), their performance in terms of time required for the caries removal, patient subjective pain reaction, their radiographic success and their antimicrobial effect in comparison with Atraumatic Restorative Treatment (ART) hand excavation method for caries removal. The trial will include 108 children with age ranging between 8 and 10 years old who have at least one carious first permanent molar will be randomly divided into three groups. A three-arm randomized clinical trial where test groups, group I, caries removal will be using Brix 3000, and group II Papacarie duo will be used, while the control group hand excavation will be the method of caries removal. Dentin samples of three groups will be taken prior to and following caries removal. The total viable streptococci and lactobacilli count will be determined and expressed as colony forming units per milliliter (CFU). The time required for caries removal with each method will be calculated and the subjective pain reaction following each method will be recorded. After complete caries removal step, it will be followed by restoration with glass ionomer restoration. Patients will be followed up at 3-, 6- and 12-month intervals to determine the clinical success and at 6- and 12- month intervals for the radiographic success rate for each caries removal method.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2023
CompletedFirst Submitted
Initial submission to the registry
June 9, 2023
CompletedFirst Posted
Study publicly available on registry
August 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedApril 2, 2024
June 1, 2023
1.2 years
June 9, 2023
March 31, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
To assess and compare the efficacy of two chemo-mechanical agents Brix 3000 and Papacarie duo in terms of their clinical success in young permanent molars, in comparison with hand excavation approach
The clinical assessment will be at 3-, 6- and 12-month intervals to evaluate restoration success according to the criteria of atraumatic restorative treatment by Phantumvanit et al. (1996) .Restorations which will receive a score of 0, 1 or 7 will be considered successful while those having a score of 2, 3, 4 or 8 will be considered failures. Those which will receive a score of 5, 6 will be excluded from the analysis.
one year follow up
To assess and compare the efficacy of two chemo-mechanical agents Brix 3000 and Papacarie duo in terms of their radiographic success in young permanent molars, in comparison with hand excavation approach
The radiographic evaluation will be performed using the radiographic subtraction method
one year follow up
Secondary Outcomes (3)
the required time for complete caries removal for each method
immediately after the intervention
f patients' subjective pain reactions following each method
immediately after the intervention
antimicrobial effect of two chemo-mechanical caries removal agents
immediately after the intervention
Study Arms (3)
BRIX 3000
EXPERIMENTALbrix 3000 used
Papacarie
ACTIVE COMPARATORpapacarie duo used
Hand excavation
ACTIVE COMPARATORhand excavation used
Interventions
Eligibility Criteria
You may qualify if:
- Healthy children aged 8-10 years old.
- The presence of at least one deep carious class 1 lesion in the first permanent molar with a score of 5 or 6 according to the International Detection and Assessment System (ICDAS), detected by visual-tactile inspection to assess lesion severity
You may not qualify if:
- Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling or abscess.
- Pulpal exposure or bleeding during the excavation procedure
- Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases affecting salivary flow.
- Allergy or sensitivity to any of the materials included in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry
Alexandria, Egypt
Related Publications (1)
Hassanein PH, Samaha AWM, Zakaria AS, Talaat DM. One-year clinical and radiographic evaluation of young permanent molars treated with brix 3000 vs. papacarie duo: a randomized controlled clinical trial. BMC Oral Health. 2025 Sep 23;25(1):1421. doi: 10.1186/s12903-025-06715-7.
PMID: 40988041DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dalia A Talaat, PHD
Alexandria University
Central Study Contacts
Abdelwahab Samaha, PHD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2023
First Posted
August 9, 2023
Study Start
April 1, 2023
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
April 2, 2024
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- June 2023- June 2024
- Access Criteria
- Researchers interested
study protocol will be availabe