Evaluation of Chemo-mechanical Caries Removal Materials in Caries Removal

Damascus University

Status: Completed

Conditions: Dental Caries

Treatments: Procedure: Excavation with Selecti-solve; Procedure: Excavation with Papacarie Duo; Procedure: Excavation with Sodium Hypochlorite Gel 2.5%.; Procedure: Traditional Escavation; Procedure: Excavation with Brix3000

Study type: Interventional

Funder types: Other

Identifiers

NCT05733923

UDDS-OperativeDent-01-2023

Details and patient eligibility

About

• The evolution of conservative dentistry that adopts the preservation of tooth structure and affected dentin that can remineralize and save the pulp from exposure, in addition to pain and fear that companies' traditional caries removal methods had led to the development of chemomechanical caries removal materials (CMCR).

The old generations of CMCR agents were NaOcl-based materials which have disadvantages such as odor taste, Unpleasant smell, high cost, Limited shelf life, and time consumption.

• All of the reasons described led to a new generation of CMCR materials depending on Enzymes such as Papain.

Brix3000 and Papacarie duo are Papain-based materials with promising effects in caries removal and fewer disadvantages.

Selecti-solve is a dental gel whose active ingredient is papain enzyme, it removes dental caries without the need for anesthesia and is selective for the infected dentin layer only which avoids the unnecessary loss of dentin, enamel breaking, and pulp exposure.

This study aims to evaluate the efficacy of Papain-based materials compared to old NAOcl-Based materials in reducing the disadvantages of CMCR agents.

Full description

In previous literature, there has not been any study that compared the whole group of chemo-mechanical caries removal materials with such a unique collection of Papain-based CMCR agents.

Papain-based agents could be promising materials in the evolution of Atraumatic Restorative treatment (ART) and Chemomechanical Caries removal methods that support conservative dentistry and the conservation of tooth structure and pulp vitality.

Brix3000 has EBE technology (Encapsulating Buffer Emulsion) that claims to elevate the efficiency of Papain Enzyme and permits the use of a higher concentration of Papain 3,000 U/mg in the whole material (10%).

Papacarie Duo has a unique combination of the main component of Papain Enzyme 6,000 U/mg and a small percentage of chloramine t that claims to increase efficiency and reduce the side effect of chloramine-based CMCR materials.

Selecti-solve is a new material that consists of Papain as the main product and has promising effects in chemo-mechanical caries removal methods.

Enrollment: 90 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Wide carious lesion (Class 1 Black) on Molars at the middle third of dentine confirmed with a periapical x-ray
• No pulp involvement is assured with a periapical radiograph.
• Good oral hygiene
• Cooperated patient.
• No oral diseases.

Exclusion criteria

• Pulp exposure or bleeding during excavation.
• Pregnancy
• Systematic diseases
• Gingival and periodontal involvement.
• Lack of patient cooperation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 5 patient groups

Traditional excavation

Active Comparator group

Description:

Mechanical caries Removal with low-speed Carbide Burs on a micromotor handpiece with air and water cooling.

Treatment:

Procedure: Traditional Escavation

Sodium Hypochlorite CMCR

Experimental group

Description:

chemomechanical caries removal using Sodium Hypochlorite Gel 2.5%.

Treatment:

Procedure: Excavation with Sodium Hypochlorite Gel 2.5%.

Papacarie duo CMCR

Experimental group

Description:

chemomechanical caries removal using Papacarie duo.

Treatment:

Procedure: Excavation with Papacarie Duo

Selecti-solve CMCR

Experimental group

Description:

chemomechanical caries removal using Selecti-solve Gel.

Treatment:

Procedure: Excavation with Brix3000

Brix3000 CMCR

Experimental group

Description:

chemomechanical caries removal using Brix3000.

Treatment:

Procedure: Excavation with Selecti-solve