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Search / Trial NCT05374434

A First in Human Study to Compare Feasibility of Inertial Cavitation Irrigation to SNI in Root Canal Treatment.

Launched by LUMENDO AG · May 10, 2022

Trial Information

Current as of June 23, 2025

Completed

Keywords

Root Canal Irrigation Root Canal Cleaning Root Canal Treatment Post Operative Pain Root Canal Disinfection Inertial Cavitation Na O Cl Irrigation Debridement

ClinConnect Summary

Inclusion Criteria:

1. Physical status classification system described was used for patients' recruitment. Healthy patients, who were classified by the American Society of Anaesthesiologists (ASA) as ASA I and II
2. Patients with the age of 18 and over
3. Patients who were diagnosed as in need of non-surgical orthograde root canal treatment of an asymptomatic tooth
4. Tooth without signs of previously initiated Root Canal Therapy

Exclusion Criteria:

1. Pregnant and lactating females
2. Patients with chronic periodontal diseases
3. Patients with sensitivity or adverse reactions to any med...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Physical status classification system described was used for patients' recruitment. Healthy patients, who were classified by the American Society of Anaesthesiologists (ASA) as ASA I and II
  • 2. Patients with the age of 18 and over
  • 3. Patients who were diagnosed as in need of non-surgical orthograde root canal treatment of an asymptomatic tooth
  • 4. Tooth without signs of previously initiated Root Canal Therapy
  • Exclusion Criteria:
  • 1. Pregnant and lactating females
  • 2. Patients with chronic periodontal diseases
  • 3. Patients with sensitivity or adverse reactions to any medication or materials that were used throughout the treatment procedure
  • 4. Patients with acute periapical periodontitis
  • 5. Patients with acute periodontal abscess
  • 6. Patients who could not abide by the follow-up time
  • 7. Patients who used analgesics 1-week prior or antibiotics 1-month prior to treatment
  • 8. Uncooperative patients
  • 9. Teeth that cannot be made functional nor restored or difficult to access teeth with no importance (wisdom teeth)
  • 10. Teeth with poor prognosis, for example, due to deep root caries or big root resorption
  • 11. Teeth with more than/or equal 4 mm periodontal pocket depth
  • 12. Teeth with an inaccessible root end
  • 13. Teeth with apical resorption or a radiologically not clearly defined apex
  • 14. Fractured teeth
  • 15. Teeth with immature or open apices
  • 16. Teeth with root apices extending into the maxillary sinus
  • 17. Teeth with external resorption communicating with the pulp

About Lumendo Ag

Lumendo AG is a pioneering biotechnology company dedicated to advancing innovative therapeutic solutions in the field of minimally invasive procedures. With a strong focus on developing cutting-edge technologies, Lumendo AG aims to enhance patient outcomes through its proprietary platforms that integrate advanced imaging and precision delivery systems. Committed to rigorous research and development, the company collaborates with leading medical institutions and experts to bring transformative treatments to market, ultimately improving the quality of care in various medical specialties.

Locations

Istanbul, Unkapanı, Fatih, Turkey

Patients applied

0 patients applied

Trial Officials

Tan Firat EYÜBOĞLU, DDS, MDS

Principal Investigator

İstanbul Medipol University, Department of Endodontics, İstanbul/Türkiye

Mutlu ÖZCAN, DDS, MDS

Study Director

İstanbul Medipol University, Istanbul Turkey

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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