Evaluation of Antimicrobial Efficacy and Adaptability of Bioceramic Sealer Containing Nanoparticles

NCT04481945 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: END 6115018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Successful endodontic treatment depends primarily on the elimination of infecting microorganisms. This is done by chemo-mechanical preparation of root canals, which is not enough and microorganisms might still survive. Thus, from the main requirements of sealers is to have antibacterial properties and adaptability. Those requirements are needed to kill persisting bacteria after obturation and provide effective seal. Therefore, nanosilver and chitosan inserted to BC sealer and so the antibacterial activity will be assessed on E. faecalis using direct contact test after the setting of the sealer, and the results will be reported using percentage reduction of the colony forming units. Besides, adaptability will be assessed using scanning electron microscope.

Conditions

Endodontic Disease

Outcome Measures

Primary Outcomes (1)

• Antibacterial efficacy Measuring antibacterial effect of sealers

  Counting the colony forming units (in-vitro study)

  24 hours

Secondary Outcomes (1)

• adaptability

  24 hours

Study Arms (3)

bioceramic sealer

ACTIVE COMPARATOR

pre-mixed bioceramic obturation material. It is dispensed using a syringe in cases of root canal obturation and with either a syringe or as a putty when doing root repair and retrograde fillings.

Drug: bioceramic sealer

bioceramic sealer and silver nanoparticles

EXPERIMENTAL

silver nanoparticles are antibacterial ions that can interact with multiple targets in the bacterial cell

Drug: bioceramic sealer

bioceramic sealer and chitosan

EXPERIMENTAL

chitosan has an excellent antibacterial, antiviral and antifungal properties, as an antibacterial, it works better on gram negative than gram positive

Drug: bioceramic sealer

Interventions

bioceramic sealer DRUG

pre-mixed bioceramic obturation material. It is dispensed using a syringe in cases of root canal obturation and with either a syringe or as a putty when doing root repair and retrograde fillings.

Also known as: total fill

bioceramic sealer; bioceramic sealer and chitosan; bioceramic sealer and silver nanoparticles

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Sound extracted anterior without any signs of caries
• No cracks
• No resorption or immature apices
• Single rooted with single canal confirmed radiographically both buccolingually and mesiodistally

You may not qualify if:

• Calcified canals
• Internal or external resorption
• Crown or root fractures

Sponsors & Collaborators

• Misr International University: lead

Study Sites (1)

Misr International university, Faculty of Oral and Dental Medicine

Cairo, 11218, Egypt

Location

Related Publications (1)

• 1. Ricucci D, Siqueira JF. Fate of the Tissue in Lateral Canals and Apical Ramifications in Response to Pathologic Conditions and Treatment Procedures. Journal of Endodontics. 2010;836(1):1-15. 2. Waltimo T, Trope M, Haapasalo M, Ørstavik D. Clinical efficacy of treatment procedures in endodontic infection control and one year follow-up of periapical healing. J Endod. 2005;31(12):863-66. 3. Khayat A, Lee SJ, Torabinejad M. Human saliva penetration of coronally unsealed obturated root canals. J Endod. 1993 ;19(9):458-61. 4. Ingle J, Bakland L, Baumgartner J. Endodontics 6. 2008. 997-1018 p. 5. Kayaoglu G, Erten H, Alaçam T, Ørstavik D. Short-term antibacterial activity of root canal sealers towards Enterococcus faecalis. Int Endod J. 2005;38(7):483-88. 6. Wu D, Fan W, Kishen A, Gutmann JL, Fan B. Evaluation of the antibacterial efficacy of silver nanoparticles against Enterococcus faecalis biofilm. J Endod [Internet]. 2014;40(2):285-90. 7. Alabdulmohsen ZA, Saad AY. Antibacterial effect of silver nanoparticles against Enterococcus faecalis. Saudi Endod J. 2017;7(1):29-35. 8. Monajemzadeh A, Ahmadi Asoor S, Aslani S, Sadeghi-Nejad B. In vitro antimicrobial effect of different root canal sealers against oral pathogens. Curr Med Mycol. 2017; 3(2):7-12. 9. Barros J, Silva MG, Rodrigues MA, Alves FRF, Lopes MA, Pina-Vaz I, et al. Antibacterial, physicochemical and mechanical properties of endodontic sealers containing quaternary ammonium polyethylenimine nanoparticles. Int Endod J. 2014;47(8):725-34. 10. ElKateb WM, Massoud AG, Mokhless NA, Shalaby TI. Measurement of Tubular Penetration Depth of Three Types of Nanoparticles Mixed With Endodontic Sealer Using Scanning Electron Microscope (An in vitro study). J Am Sci. 2015;11(11):111-22. 11. HUANG Y, ORHAN K, CELIKTEN B, ORHAN AI, TUFENKCI P, SEVIMAY S. Evaluation of the sealing ability of different root canal sealers: a combined SEM and micro-CT study. J Appl Oral Sci [Internet]. 2018;26(0):1-8. 12. Naghavi N, Mortazavi M, Nejat A, Javidi M, Zarei M. Zinc oxide nano-particles as sealer in endodontics and its sealing ability. Contemp Clin Dent. 2014; Jan-Mar;5(1):20-24. 13. Kim JS, Kuk E, Yu KN, Kim JH, Park SJ, Lee HJ, et al. Antimicrobial effects of silver nanoparticles. Nanomedicine Nanotechnology, Biol Med. 2007;3(1):95-101. 14. Rai MK, Deshmukh SD, Ingle AP, Gade AK. Silver nanoparticles: The powerful nanoweapon against multidrug-resistant bacteria. J Appl Microbiol. 2012;112(5):841-52. 15. Gomes-Filho JE, Silva FO, Watanabe S, Angelo Cintra LT, Tendoro KV, Dalto LG, et al. Tissue Reaction to Silver Nanoparticles Dispersion as an Alternative Irrigating Solution. J Endod [Internet]. 2010 Oct 1;36(10):1698-702. 16. Kangarlou A, Tashfam B, Naseri M, Dianat O, Taheri S. In Vitro Comparison of Antibacterial Efficacy of a New Irrigation Solution Containing Nanosilver with Sodium Hypochlorite and Chlorhexidine. J Dent Sch. 2013;31(1):1-7. 17. Del Carpio-Perochena A, Kishen A, Shrestha A, Bramante CM. Antibacterial Properties Associated with Chitosan Nanoparticle Treatment on Root Dentin and 2 Types of Endodontic Sealers. J Endod. 2015; 41(8):1353-58. 18. Rabea EI, Badawy MET, Stevens C V., Smagghe G, Steurbaut W. Chitosan as antimicrobial agent: Applications and mode of action. Vol. 4, Biomacromolecules. 2003. p. 1457-65. 19. Kishen A, Shi Z, Shrestha A, Neoh KG. An Investigation on the Antibacterial and Antibiofilm Efficacy of Cationic Nanoparticulates for Root Canal Disinfection. J Endod. 2008;34(12):1515-20 20. Shrestha A, Kishen A. Antibacterial Nanoparticles in Endodontics: A Review. J Endod. 2016;42(10):1417-26. 21. Wang Z, Shen Y, Haapasalo M. Dentin extends the antibacterial effect of endodontic sealers against Enterococcus faecalis biofilms. J Endod. 2014;40(4):505-8.

  BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• N M Yehia, MA

  teaching assistant at Misr International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding; Assessor blinding, where both the evaluators and statisticians will be blinded to the treatment groups.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Nanosilver and chitosan inserted to BC sealer and so the antibacterial activity will be assessed on E. faecalis using direct contact test after the setting of the sealer, and the results will be reported using percentage reduction of the colony forming units.

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 22, 2020
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

EG (1)