Evaluation of Chemo-mechanical Caries Removal Materials in Caries Removal
NCT ID: NCT05733923
Last Updated: 2024-07-09
Study Results
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Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2023-02-25
2024-05-15
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Traditional excavation
Mechanical caries Removal with low-speed Carbide Burs on a micromotor handpiece with air and water cooling.
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.
Sodium Hypochlorite CMCR
chemomechanical caries removal using Sodium Hypochlorite Gel 2.5%.
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%.
Papacarie duo CMCR
chemomechanical caries removal using Papacarie duo.
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.
Selecti-solve CMCR
chemomechanical caries removal using Selecti-solve Gel.
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.
Brix3000 CMCR
chemomechanical caries removal using Brix3000.
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.
Interventions
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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.
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%.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* No pulp involvement is assured with a periapical radiograph.
* Good oral hygiene
* Cooperated patient.
* No oral diseases.
Exclusion Criteria
* Pregnancy
* Systematic diseases
* Gingival and periodontal involvement.
* Lack of patient cooperation.
18 Years
40 Years
ALL
No
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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Souad Abboud, DDS MSc PhD
Role: STUDY_CHAIR
Associate Professor of Restorative Dentistry, University of Damascus Faculty of Dentistry, Damascus
MHD Baraa Alsayed, DDS
Role: PRINCIPAL_INVESTIGATOR
MSc student, Department of Restorative Dentistry, University of Damascus, Damascus, Syria
Locations
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Faculty of Dentistry, Damascus University
Damascus, , Syria
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Mancini L, Pisaneschi A, Mancini V, Ginoble M, Quinzi V, Marchetti E, Marzo G. BRIX3000(R) Papain Gel for Cavity Treatment in the Adult Patient. Case Rep Dent. 2021 Jun 12;2021:6624825. doi: 10.1155/2021/6624825. eCollection 2021.
Matsumoto SF, Motta LJ, Alfaya TA, Guedes CC, Fernandes KP, Bussadori SK. Assessment of chemomechanical removal of carious lesions using Papacarie Duo: randomized longitudinal clinical trial. Indian J Dent Res. 2013 Jul-Aug;24(4):488-92. doi: 10.4103/0970-9290.118393.
Other Identifiers
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UDDS-OperativeDent-01-2023
Identifier Type: -
Identifier Source: org_study_id
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