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Clinical Evaluation and Antimicrobial Effect of Papain Based Chemo-mechanical Caries Removal Agents

NCT05983900 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2024-04-02

No results posted yet for this study

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.

Conditions

  • Dental Caries

Interventions

PROCEDURE

BRIX3000

chemo-mechanical caries removal agent

PROCEDURE

papacarie

chemo-mechanical caries removal agent

PROCEDURE

hand excavation

mechanical caries removal

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Dalia A Talaat, PHD · Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05983900 on ClinicalTrials.gov