N/A
N=10
A First in Human Study to Compare Feasibility of Inertial Cavitation Irrigation to SNI in Root Canal Treatment.
Root Canal Treatment · Post Operative Pain
Bottom Line
View on ClinicalTrials.gov: NCT05374434 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Clinical Postoperative Pain — 30.5; 20.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Conventional irrigation (Other); Inertial cavitation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lumendo AG
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Postoperative Pain |
11.58; 4 | — |
| PRIMARY Clinical Postoperative Pain |
11.58; 4 | — |
| PRIMARY Clinical Postoperative Pain |
11.58; 4 | — |
| PRIMARY Clinical Postoperative Pain |
11.58; 4 | — |
| PRIMARY Clinical Postoperative Pain |
11.58; 4 | — |
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 study is to compare the postoperative pain intensity levels in patients with asymptomatic teeth diagnosed for non-surgical orthograde root canal treatment that are disinfected during the root canal treatment procedure by manual irrigation with sodium hypochlorite (NaOCl) solution using an endodontic needle or by a inertial cavitation-generating device.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05374434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.