NCT04481945

Evaluation of Antimicrobial Efficacy and Adaptability of Bioceramic Sealer Containing Nanoparticles

Completed Phase 4 Last updated 27 January 2022

What this trial tests

Phase 4 trial testing bioceramic sealer in Endodontic Disease in 30 participants. Completed in 1 January 2022.

Timeline

1 June 2021

Primary endpoint
1 December 2021

1 January 2022

Quick facts

Lead sponsor	Misr International University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	1 June 2021
Primary completion	1 December 2021
Estimated completion	1 January 2022
Sites	1 location across Egypt

Drugs / interventions tested

• bioceramic sealer — full drug profile →

Conditions studied

• Endodontic Disease — all drugs for Endodontic Disease →

Sponsor

Misr International University

Who can join

Eligibility, any sex, with Endodontic Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Overview of Metal Nanoparticles' Synthesis, Characterization, and Biomedical Applications, with a Focus on Silver and Gold Nanoparticles.
   Burlec AF, Corciova A, Boev M, Batir-Marin D, et al · · 2023 · cited 93× · PMID 37895881 · DOI 10.3390/ph16101410
2. Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies.
   Domingues C, Jarak I, Veiga F, Dourado M, et al · · 2023 · cited 33× · PMID 37896191 · DOI 10.3390/pharmaceutics15102431
3. Self-Therapeutic Nanomaterials: Applications in Biology and Medicine.
   Seaberg J, Clegg JR, Bhattacharya R, Mukherjee P. · · 2023 · cited 28× · PMID 36938366 · DOI 10.1016/j.mattod.2022.11.007
4. Nanomaterials-Based Combinatorial Therapy as a Strategy to Combat Antibiotic Resistance.
   León-Buitimea A, Garza-Cárdenas CR, Román-García MF, Ramírez-Díaz CA, et al · · 2022 · cited 23× · PMID 35740200 · DOI 10.3390/antibiotics11060794
5. Chitosan Micro/Nanocapsules in Action: Linking Design, Production, and Therapeutic Application.
   Pérez-Pacheco Y, Tylkowski B, García-Valls R. · · 2025 · cited 12× · PMID 39860124 · DOI 10.3390/molecules30020252
6. Nanoparticle-based approaches for bacterial detection and therapy.
   Rajana VK, Matireddy A, Miriyals J, Lakshmi KYN, et al · · 2026 · PMID 41748974 · DOI 10.1007/s00253-026-13766-5