Status:

COMPLETED

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

Lead Sponsor:

Lumendo AG

Conditions:

Root Canal Treatment

Post Operative Pain

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The study design is a single-center 2-arm randomized controlled clinical trial. 10 subjects (teeth) requiring a root canal treatment will be enrolled in 2 groups (5 in each group). The aim of the stud...

Detailed Description

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...

Eligibility Criteria

Inclusion

  • 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
  • Patients with the age of 18 and over
  • Patients who were diagnosed as in need of non-surgical orthograde root canal treatment of an asymptomatic tooth
  • Tooth without signs of previously initiated Root Canal Therapy

Exclusion

  • Pregnant and lactating females
  • Patients with chronic periodontal diseases
  • Patients with sensitivity or adverse reactions to any medication or materials that were used throughout the treatment procedure
  • Patients with acute periapical periodontitis
  • Patients with acute periodontal abscess
  • Patients who could not abide by the follow-up time
  • Patients who used analgesics 1-week prior or antibiotics 1-month prior to treatment
  • Uncooperative patients
  • Teeth that cannot be made functional nor restored or difficult to access teeth with no importance (wisdom teeth)
  • Teeth with poor prognosis, for example, due to deep root caries or big root resorption
  • Teeth with more than/or equal 4 mm periodontal pocket depth
  • Teeth with an inaccessible root end
  • Teeth with apical resorption or a radiologically not clearly defined apex
  • Fractured teeth
  • Teeth with immature or open apices
  • Teeth with root apices extending into the maxillary sinus
  • Teeth with external resorption communicating with the pulp

Key Trial Info

Start Date :

May 10 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 31 2022

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT05374434

Start Date

May 10 2022

End Date

May 31 2022

Last Update

July 25 2024

Active Locations (1)

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1

İstanbul Medipol Universitesi, Faculty of Dentistry, Department of Endodontics

Istanbul, Unkapanı, Fatih, Turkey (Türkiye), 34083