Evaluation of Antimicrobial Efficacy and Adaptability of Bioceramic Sealer Containing Nanoparticles
Primary Purpose
Endodontic Disease
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
bioceramic sealer
Sponsored by
About this trial
This is an interventional treatment trial for Endodontic Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Calcified canals
- Internal or external resorption
- Crown or root fractures
Sites / Locations
- Misr International university, Faculty of Oral and Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
bioceramic sealer
bioceramic sealer and silver nanoparticles
bioceramic sealer and chitosan
Arm Description
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.
silver nanoparticles are antibacterial ions that can interact with multiple targets in the bacterial cell
chitosan has an excellent antibacterial, antiviral and antifungal properties, as an antibacterial, it works better on gram negative than gram positive
Outcomes
Primary Outcome Measures
Antibacterial efficacy Measuring antibacterial effect of sealers
Counting the colony forming units (in-vitro study)
Secondary Outcome Measures
adaptability
Assessment of adaptation using scanning electron microscope
Full Information
NCT ID
NCT04481945
First Posted
June 25, 2019
Last Updated
January 21, 2022
Sponsor
Misr International University
1. Study Identification
Unique Protocol Identification Number
NCT04481945
Brief Title
Evaluation of Antimicrobial Efficacy and Adaptability of Bioceramic Sealer Containing Nanoparticles
Official Title
Evaluation of Antimicrobial Efficacy and Adaptability to Root Canal Dentin of Bioceramic Sealer Containing Nanoparticles (In-vitro Study)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Misr International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The main purpose of endodontic therapy is to clean and shape the root canals. This is done by means of instruments and chemical irrigants in order to effectively control the pulpal and periapical infection. That chemomechanical preparation aims to reduce the microorganisms count but cannot completely eliminate it. This is mainly due to (i) anatomical complexity and access limitations (ii) incompetent chemomechanical preparations leaving surfaces untouched (iii) ineffectual irrigation. Besides, despite an accurate chemomechanical preparation, infection may persist in 20-33% of cases, even if intracanal medicament is used.
Treatment failure may also occur due to microleakage, which occurs due to interfacial gaps between the gutta-percha and the sealer, the sealer and the dentin, or through voids within the sealer. Fifty eight percent of treatment failures happen due to incomplete obturation and that's why, hermetic seal is the main factor associated with the success of root canal treatment . Therefore, disinfection, gap-free, three dimensional obturation are the main requisites for treatment standards in endodontics.
Another reason for treatment failure is presence of persisting bacteria. Enterococcus faecalis is a resistant bacterium commonly retrieved from obturated root canals with post treatment disease (apical periodontitis). This pathogen is believed to be highly virulent; it can invade dentinal tubules, adhere, overcome environmental challenges and form biofilm.. Besides, it can resist intracanal disinfectants and medicaments. Therefore, the best approach to resolve this is by using a sealer with broad spectrum antibacterial action.
Ideal root-canal sealer should be able to kill microorganisms on direct contact on the dentinal walls and those present deep inside the dentinal root canals. That means that it should be able to diffuse inside the dentinal tubules to entomb and kill surviving bacteria. Besides, it should be capable of perfectly sealing the prepared canal to block any space and nutrients needed for bacterial growth. Finally, endodontic sealers that retain flowability and antimicrobial properties may help eliminate microorganisms in the root canal system.
Dspite the fact that most sealers have antibacterial constituents, their antibacterial activity is eventually lost after setting. Besides, even if it doesn't, these constituents have to be liberated from the set sealer matrix to fulfill their function. Then again, their release would be accompanied by disintegration of the sealer, interfacial gaps and later on bacterial recolonization.
Moreover,the current root filling materials aren't enough for reaching a complete, gap-free obturation. That would be due to the dimensional changes and lack of adhesion between Gutta percha and dentin. And that is why endodontic sealers are used. Thus, the adaptability of the sealer to the dentin is the main factor influencing microleakage and reinfection.
Nanotechnology is the science of producing materials in nano-dimensions by re-location and re-arrangement of atoms to prepare materials with better properties. It is considered a great advancement in the field of medicine. It can be beneficial in producing material with superior properties by enhancing surface to volume ratio. Besides, having antibacterial nanoparticles are shown to have better antibacterial action than their powder counterparts. That would be due to their higher surface area and charge density which favor their interaction with the negatively charged bacterial surface.
Resistance in pathogens is a major challenge in field like biomedicine. Chemical antimicrobial agents depend on binding to specific receptor for their antimicrobial action, which by time lead to multidrug resistance. . On the other hand, antibacterial nanoparticles such as nanosilver interact with multiple targets in the bacterial cell. Therefore, providing the bacteria with the least chance of gaining resistance.
The mechanism of action of silver ions. Silver ions are highly reactive. They start by binding to proteins on the bacterial cell leading to structural changes, which leads to cell distortion and death. Silver ions also can inhibit the bacterial replication, by binding and denaturing its DNA. Moreover, they can react with thiol group of proteins, followed by DNA condensation resulting in the cell death.
Although, silver nanoparticle's potential disadvantage is its toxicity towards mammalian cells. A number of studies proved that silver is safe as long as it's used in small concentrations. A study assessed the tissue response of silver nanoparticles dispersion embedded in fibrin sponge and implanted in polyethylene tubes. They concluded that silver nanoparticles dispersion was biocompatible at low concentrations. Another study stated that silver nanoparticles at low concentrations are effective against microorganisms without any toxic effect on eukaryotic cells.
Furthermore, there is a natural cationic biopolymer which can overcome the silver nanoparticles shortcomings and still provide an antibacterial efficacy. Chitosan (CS) is usually obtained by the alkaline deacetylation of chitin, which is the main component of the exoskeleton of crustaceans. CS has an excellent antibacterial, antiviral and antifungal properties, as an antibacterial, it works better on gram negative than gram positive. Besides, the addition of CS nanoparticles into zinc-oxide eugenol sealer in a membrane restricted assay. They proved that CS improved the antibacterial property suggesting that it can diffuse and penetrate dentinal tubules and anatomical complexities.
The mechanism of action of CS and stated that it's contact-mediated killing. It starts by electrostatic attraction of positively charged CS with negatively charged bacterial cell membrane. That is followed by altered cell permeability, resulting in rupture of cells and leakage of the intracellular components.
Finally, as reflected earlier, successful endodontic treatment depend on disinfecting the canals and providing a hermetic seal. That's why; this study's target is to assess the antibacterial efficacy and adaptability of bioceramic sealer when incorporated with nanosilver and chitosan respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Blinding; Assessor blinding, where both the evaluators and statisticians will be blinded to the treatment groups.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bioceramic sealer
Arm Type
Active Comparator
Arm Description
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.
Arm Title
bioceramic sealer and silver nanoparticles
Arm Type
Experimental
Arm Description
silver nanoparticles are antibacterial ions that can interact with multiple targets in the bacterial cell
Arm Title
bioceramic sealer and chitosan
Arm Type
Experimental
Arm Description
chitosan has an excellent antibacterial, antiviral and antifungal properties, as an antibacterial, it works better on gram negative than gram positive
Intervention Type
Drug
Intervention Name(s)
bioceramic sealer
Other Intervention Name(s)
total fill
Intervention Description
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.
Primary Outcome Measure Information:
Title
Antibacterial efficacy Measuring antibacterial effect of sealers
Description
Counting the colony forming units (in-vitro study)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
adaptability
Description
Assessment of adaptation using scanning electron microscope
Time Frame
24 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Calcified canals
Internal or external resorption
Crown or root fractures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
N M Yehia, MA
Organizational Affiliation
teaching assistant at Misr International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Misr International university, Faculty of Oral and Dental Medicine
City
Cairo
ZIP/Postal Code
11218
Country
Egypt
12. IPD Sharing Statement
Citations:
Citation
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.
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Evaluation of Antimicrobial Efficacy and Adaptability of Bioceramic Sealer Containing Nanoparticles
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