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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05374434
Other study ID # LUM-EC-001-060522
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2022
Est. completion date May 31, 2022

Study information

Verified date August 2022
Source Lumendo AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date May 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Conventional irrigation
The participant will be treated by manual irrigation with sodium hypochlorite NaOCl.
Device:
Inertial cavitation
The participant will be treated by inertial cavitation-generating device, that generates hydraulic cavitation to clean root canals deeper and more effectively than other existing systems.

Locations

Country Name City State
Turkey Istanbul Medipol Universitesi, Faculty of Dentistry, Department of Endodontics Istanbul Unkapani, Fatih

Sponsors (2)

Lead Sponsor Collaborator
Lumendo AG Soteria Danismanlik

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical postoperative pain VAS score of patient's level of pain, from no pain to extreme pain 6 hours
Primary Clinical postoperative pain VAS score of patient's level of pain, from no pain to extreme pain 24 hours
Primary Clinical postoperative pain VAS score of patient's level of pain, from no pain to extreme pain 48 hours
Primary Clinical postoperative pain VAS score of patient's level of pain, from no pain to extreme pain 72 hours
Primary Clinical postoperative pain VAS score of patient's level of pain, from no pain to extreme pain 1 week
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