Post Operative Pain Clinical Trial
Official title:
Comparative Evaluation of the Effectiveness of Root Canal Preparation After Irrigation Using Endodontic Needle and Inertial Cavitation: A Randomized Controlled Trial
Verified date | August 2022 |
Source | Lumendo AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medipol Universitesi, Faculty of Dentistry, Department of Endodontics | Istanbul | Unkapani, Fatih |
Lead Sponsor | Collaborator |
---|---|
Lumendo AG | Soteria Danismanlik |
Turkey,
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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