Evaluation of Chemo-mechanical Caries Removal Materials in Caries Removal

NCT05733923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-07-09

No results posted yet for this study

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.

Conditions

  • Dental Caries

Interventions

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.

Sponsors & Collaborators

  • Damascus University

    lead OTHER

Principal Investigators

  • Souad Abboud, DDS MSc PhD · Associate Professor of Restorative Dentistry, University of Damascus Faculty of Dentistry, Damascus

  • MHD Baraa Alsayed, DDS · MSc student, Department of Restorative Dentistry, University of Damascus, Damascus, Syria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-25
Primary Completion
2023-10-15
Completion
2024-05-15

Countries

  • Syria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05733923 on ClinicalTrials.gov