Evaluation of Chemo-mechanical Caries Removal Materials in Caries Removal

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Procedure: Traditional Escavation
* Procedure: Excavation with Sodium Hypochlorite Gel 2.5%.
* Procedure: Excavation with Papacarie Duo
* Procedure: Excavation with Brix3000
* Procedure: Excavation with Selecti-solve


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional excavation<br>Mechanical caries Removal with low-speed Carbide Burs on a micromotor handpiece with air and water cooling. | Procedure: Traditional Escavation<br>* 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.<br>|
| Experimental: Sodium Hypochlorite CMCR<br>chemomechanical caries removal using Sodium Hypochlorite Gel 2.5%. | Procedure: Excavation with Sodium Hypochlorite Gel 2.5%.<br>* 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%.<br>|
| Experimental: Papacarie duo CMCR<br>chemomechanical caries removal using Papacarie duo. | Procedure: Excavation with Papacarie Duo<br>* 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.<br>|
| Experimental: Selecti-solve CMCR<br>chemomechanical caries removal using Selecti-solve Gel. | Procedure: Excavation with Brix3000<br>* 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.<br>|
| Experimental: Brix3000 CMCR<br>chemomechanical caries removal using Brix3000. | Procedure: Excavation with Selecti-solve<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success in caries removal by a detecting dye | The efficacy of caries removal will be assessed by a sharp probe aided by Caries Detector dye. The Cavity will be inspected after every application by a sharp probe to feel any tacky sensation in dentin, when it is all hard dentin, caries detector dye will be applied to aid the investigation. Caries detector dye will be left for 10 seconds and then rinsed with water, it will stain the organic matrix of less mineralized dentin so the cavity should be stained homogeneously so high-intensity colored spots refer to infected dentin and it will be removed. | After procedure completion, which is expected to be within 20 minutes on average. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for caries removal | Time from the beginning of the caries excavation to the end of the process will be recorded in minutes using a stopwatch. | After procedure completion, which is expected to be within 20 minutes on average. | 
| Pain perception during caries removal | Visual analog scale (VAS) will be used to evaluate the pain perception during the procedure of caries removal. The patient will be asked to choose a number from 0 to 10 matching the intensity of his or her pain experience during the procedure. The higher the score, the more painful the procedure is. | After procedure completion, which is expected to be within 20 minutes on average. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chemo-mechanical caries removal, Papain-based agents, Minimum invasive dentistry, Conservative dentistry, Dental fear, Tooth Decay