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Evaluation of Chemo-mechanical Caries Removal Materials in Caries Removal

Primary Purpose

Dental Caries

Status
Recruiting
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Traditional Escavation
Excavation with Sodium Hypochlorite Gel 2.5%.
Excavation with Papacarie Duo
Excavation with Brix3000
Excavation with Selecti-solve
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Chemo-mechanical caries removal, Papain-based agents, Minimum invasive dentistry, Conservative dentistry, Dental fear, Tooth Decay

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Dentistry, Damascus UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Traditional excavation

Sodium Hypochlorite CMCR

Papacarie duo CMCR

Selecti-solve CMCR

Brix3000 CMCR

Arm Description

Mechanical caries Removal with low-speed Carbide Burs on a micromotor handpiece with air and water cooling.

chemomechanical caries removal using Sodium Hypochlorite Gel 2.5%.

chemomechanical caries removal using Papacarie duo.

chemomechanical caries removal using Selecti-solve Gel.

chemomechanical caries removal using Brix3000.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 29, 2023
Last Updated
May 22, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05733923
Brief Title
Evaluation of Chemo-mechanical Caries Removal Materials in Caries Removal
Official Title
Effectiveness of Papain-based Materials Compared With NaOCl-based Materials in Chemo-mechanical Caries Removal: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Chemo-mechanical caries removal, Papain-based agents, Minimum invasive dentistry, Conservative dentistry, Dental fear, Tooth Decay

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional excavation
Arm Type
Active Comparator
Arm Description
Mechanical caries Removal with low-speed Carbide Burs on a micromotor handpiece with air and water cooling.
Arm Title
Sodium Hypochlorite CMCR
Arm Type
Experimental
Arm Description
chemomechanical caries removal using Sodium Hypochlorite Gel 2.5%.
Arm Title
Papacarie duo CMCR
Arm Type
Experimental
Arm Description
chemomechanical caries removal using Papacarie duo.
Arm Title
Selecti-solve CMCR
Arm Type
Experimental
Arm Description
chemomechanical caries removal using Selecti-solve Gel.
Arm Title
Brix3000 CMCR
Arm Type
Experimental
Arm Description
chemomechanical caries removal using Brix3000.
Intervention Type
Procedure
Intervention Name(s)
Traditional Escavation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Excavation with Sodium Hypochlorite Gel 2.5%.
Intervention Description
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%.
Intervention Type
Procedure
Intervention Name(s)
Excavation with Papacarie Duo
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Excavation with Brix3000
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Excavation with Selecti-solve
Intervention Description
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 Outcome Measure Information:
Title
Success in caries removal by a detecting dye
Description
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.
Time Frame
After procedure completion, which is expected to be within 20 minutes on average.
Secondary Outcome Measure Information:
Title
Time required for caries removal
Description
Time from the beginning of the caries excavation to the end of the process will be recorded in minutes using a stopwatch.
Time Frame
After procedure completion, which is expected to be within 20 minutes on average.
Title
Pain perception during caries removal
Description
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.
Time Frame
After procedure completion, which is expected to be within 20 minutes on average.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MHD Baraa Alsayed, DDS
Phone
00963941900701
Email
Braaalsayed@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Souad Abboud, DDS MSc PhD
Phone
00963 933 443 119
Email
drsouadabboud@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Souad Abboud, DDS MSc PhD
Organizational Affiliation
Associate Professor of Restorative Dentistry, University of Damascus Faculty of Dentistry, Damascus
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
MHD Baraa Alsayed, DDS
Organizational Affiliation
MSc student, Department of Restorative Dentistry, University of Damascus, Damascus, Syria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Damascus University
City
Damascus
Country
Syrian Arab Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Souad Abboud, DDS MSc PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33931037
Citation
Adham MM, El Kashlan MK, Abdelaziz WE, Rashad AS. Comparison of two minimally invasive restorative techniques in improving the oral health-related quality of life of pregnant women: a six months randomized controlled trial. BMC Oral Health. 2021 Apr 30;21(1):221. doi: 10.1186/s12903-021-01581-5.
Results Reference
background
PubMed Identifier
29161950
Citation
AlHumaid J, Al-Harbi F, El Tantawi M, Elembaby A. X-ray microtomography assessment of Carisolv and Papacarie effect on dentin mineral density and amount of removed tissue. Acta Odontol Scand. 2018 May;76(4):236-240. doi: 10.1080/00016357.2017.1406614. Epub 2017 Nov 21.
Results Reference
background
PubMed Identifier
33114249
Citation
Cardoso M, Coelho A, Lima R, Amaro I, Paula A, Marto CM, Sousa J, Spagnuolo G, Marques Ferreira M, Carrilho E. Efficacy and Patient's Acceptance of Alternative Methods for Caries Removal-a Systematic Review. J Clin Med. 2020 Oct 23;9(11):3407. doi: 10.3390/jcm9113407.
Results Reference
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PubMed Identifier
34599744
Citation
de Souza TF, Martins ML, Tavares-Silva CM, Fonseca-Goncalves A, Maia LC. Treatment time, pain experience and acceptability of the technique for caries removal in primary teeth using the ART approach with or without Brix3000 papain gel: a preliminary randomised controlled clinical trial. Eur Arch Paediatr Dent. 2022 Oct;23(5):777-785. doi: 10.1007/s40368-021-00669-4. Epub 2021 Oct 2.
Results Reference
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PubMed Identifier
26393204
Citation
Divya G, Prasad MG, Vasa AA, Vasanthi D, Ramanarayana B, Mynampati P. Evaluation of the Efficacy of Caries Removal Using Polymer Bur, Stainless Steel Bur, Carisolv, Papacarie - An Invitro Comparative Study. J Clin Diagn Res. 2015 Jul;9(7):ZC42-6. doi: 10.7860/JCDR/2015/12705.6202. Epub 2015 Jul 1.
Results Reference
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PubMed Identifier
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Citation
Santos TML, Bresciani E, Matos FS, Camargo SEA, Hidalgo APT, Rivera LML, Bernardino IM, Paranhos LR. Comparison between conventional and chemomechanical approaches for the removal of carious dentin: an in vitro study. Sci Rep. 2020 May 15;10(1):8127. doi: 10.1038/s41598-020-65159-x.
Results Reference
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PubMed Identifier
34326596
Citation
Katiyar A, Gupta S, Gupta K, Sharma K, Tripathi B, Sharma N. Comparative Evaluation of Chemo-mechanical and Rotary-mechanical Methods in Removal of Caries with Respect to Time Consumption and Pain Perception in Pediatrc Dental Patients. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):115-119. doi: 10.5005/jp-journals-10005-1896.
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Citation
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Citation
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Results Reference
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Evaluation of Chemo-mechanical Caries Removal Materials in Caries Removal

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