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NCT Number: NCT05733923

Evaluation of Chemo-mechanical Caries Removal Materials in Caries Removal

• 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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Damascus University

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional Escavation

Procedure

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.

Excavation with Sodium Hypochlorite Gel 2.5%.

Procedure

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%.

Excavation with Papacarie Duo

Procedure

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.

Excavation with Brix3000

Procedure

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.

Excavation with Selecti-solve

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 17, 2023
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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