Evaluation of Chemo-mechanical Caries Removal Materials in Caries Removal

NCT05733923 | Completed DMC

• 1 other identifier: UDDS-OperativeDent-01-2023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

Chemo-mechanical caries removal; Papain-based agents; Minimum invasive dentistry; Conservative dentistry; Dental fear; Tooth Decay

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• Time required for caries removal

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

• Pain perception during caries removal

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

Study Arms (5)

Traditional excavation

ACTIVE COMPARATOR

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

Procedure: Traditional Escavation

Sodium Hypochlorite CMCR

EXPERIMENTAL

chemomechanical caries removal using Sodium Hypochlorite Gel 2.5%.

Procedure: Excavation with Sodium Hypochlorite Gel 2.5%.

Papacarie duo CMCR

EXPERIMENTAL

chemomechanical caries removal using Papacarie duo.

Procedure: Excavation with Papacarie Duo

Selecti-solve CMCR

EXPERIMENTAL

chemomechanical caries removal using Selecti-solve Gel.

Procedure: Excavation with Brix3000

Brix3000 CMCR

EXPERIMENTAL

chemomechanical caries removal using Brix3000.

Procedure: Excavation with Selecti-solve

Interventions

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.

Traditional excavation

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%.

Sodium Hypochlorite CMCR

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.

Papacarie duo CMCR

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.

Selecti-solve CMCR

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.

Brix3000 CMCR

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Pulp exposure or bleeding during excavation.
• Pregnancy
• Systematic diseases
• Gingival and periodontal involvement.
• Lack of patient cooperation.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Faculty of Dentistry, Damascus University

Damascus, Syria

Location

Related Publications (9)

• 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.

  PMID: 33931037 BACKGROUND

• 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.

  PMID: 29161950 BACKGROUND

• 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.

  PMID: 33114249 BACKGROUND

• 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.

  PMID: 34599744 BACKGROUND

• 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.

  PMID: 26393204 BACKGROUND

• 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.

  PMID: 32415190 BACKGROUND

• 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.

  PMID: 34326596 BACKGROUND

• 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.

  PMID: 34194848 BACKGROUND

• 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.

  PMID: 24047844 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Souad Abboud, DDS MSc PhD

  Associate Professor of Restorative Dentistry, University of Damascus Faculty of Dentistry, Damascus

  STUDY CHAIR

• MHD Baraa Alsayed, DDS

  MSc student, Department of Restorative Dentistry, University of Damascus, Damascus, Syria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 17, 2023
• Study Start: February 25, 2023
• Primary Completion: October 15, 2023
• Study Completion: May 15, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)