NCT05733923

Evaluation of Chemo-mechanical Caries Removal Materials in Caries Removal

Effectiveness of Papain-based Materials Compared With NaOCl-based Materials in Chemo-mechanical Caries Removal: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

• 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.

Detailed 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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
PROCEDURE	Traditional Escavation	Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. \- Group 6: 15 carious teeth will be excavated chemo-mechanically using Selecti-solve.
PROCEDURE	Excavation with Sodium Hypochlorite Gel 2.5%.	Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using Sodium Hypochlorite Gel 2.5%.
PROCEDURE	Excavation with Papacarie Duo	Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using a Papacarie Duo.
PROCEDURE	Excavation with Brix3000	Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using a Brix3000.
PROCEDURE	Excavation with Selecti-solve	Patients will receive an operative procedure to remove dental caries by traditional excavation using Carbide burs on a micromotor handpiece at low speed with air and water cooling. In addition, teeth will be excavated chemo-mechanically using a Selecti-solve.

Timeline

• Start date: 2023-02-25
• Primary completion: 2023-10-15
• Completion: 2024-05-15
• First posted: 2023-02-17
• Last updated: 2024-07-09

Locations

1 site across 1 country: Syria