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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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All the lesions in the children's oral cavity indicated for treatment will be treated and sampled for microbiological analysis prior to and following caries removal. On the day of the intervention, the children will be asked to refrain from tooth brushing in the morning, as well as eating and drinking (except water) for at least two hours before the appointment. The patients will be instructed to rinse with a cup of water, then the outer surface of the carious lesion will be washed with a flurry of water to avoid contamination of plaque bacteria. The tooth will then be partially isolated using cotton rolls and saliva ejector.

Two portions of dentin will be collected with sterile excavators from the middle of the cavity to perform the microbiological analysis of each tooth before and then after caries removal procedure. The dentin sample will then be inserted in a sterile test tube containing 1 mL of saline and transported to the microbiology laboratory within 1-2 hours. The bacterial count obtained for a given amount of dentin will be used to estimate the number of colonies present in 1 mg dentin (CFU/mg). In the CMCR group: either Papacarie duo or Brix 3000 gel will be applied on the carious lesion of tooth and left undisturbed for 30-60 seconds, following manufacturer instructions This produces softening of carious dentin, which will be removed with a hand excavator. This step will be repeated 2-3 times until dentin demonstrates slight resistance with no tug-back sensation when tested with an exploratory probe while pressing an explorer into dentin, then the application of the chemo-mechanical agents will be stop The visual test for assessment of complete caries excavation will be based on non-turbid appearance of the CMCR agent used. In the ART group hand excavation will be performed to remove the carious tissue from the cavity by using a sterile sharp hand excavator. The cavity will be determined to be caries-free according to visual and tactile clinical criteria.

No local anesthesia will be administered as it would alter the pain perception of the patient unless necessary.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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BRIX 3000

brix 3000 used

Group Type EXPERIMENTAL

BRIX3000

Intervention Type PROCEDURE

chemo-mechanical caries removal agent

Papacarie

papacarie duo used

Group Type ACTIVE_COMPARATOR

papacarie

Intervention Type PROCEDURE

chemo-mechanical caries removal agent

Hand excavation

hand excavation used

Group Type ACTIVE_COMPARATOR

hand excavation

Intervention Type PROCEDURE

mechanical caries removal

Interventions

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BRIX3000

chemo-mechanical caries removal agent

Intervention Type PROCEDURE

papacarie

chemo-mechanical caries removal agent

Intervention Type PROCEDURE

hand excavation

mechanical caries removal

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Healthy children aged 8-10 years old.
2. 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

Exclusion Criteria

1. Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling or abscess.
2. Pulpal exposure or bleeding during the excavation procedure
3. Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases affecting salivary flow.
4. Allergy or sensitivity to any of the materials included in the study

Minimum Eligible Age

8 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes