Evaluation of Chemo-mechanical Caries Removal Materials in Caries Removal

July 7, 2024 updated by: Damascus University

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

• 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success in caries removal by a detecting dye
Time Frame: After procedure completion, which is expected to be within 20 minutes on average.

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 Frame: After procedure completion, which is expected to be within 20 minutes on average.
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
Time Frame: After procedure completion, which is expected to be within 20 minutes on average.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Study Chair: Souad Abboud, DDS MSc PhD, Associate Professor of Restorative Dentistry, University of Damascus Faculty of Dentistry, Damascus
  • Principal Investigator: MHD Baraa Alsayed, DDS, MSc student, Department of Restorative Dentistry, University of Damascus, Damascus, Syria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2023

Primary Completion (Actual)

October 15, 2023

Study Completion (Actual)

May 15, 2024

Study Registration Dates

First Submitted

January 29, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 7, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-OperativeDent-01-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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