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