Comparative Evaluation of the Effectiveness of Root Canal Preparation After Irrigation Using Endodontic Needle and Inertial Cavitation

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05374434
• Other study ID #: LUM-EC-001-060522
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain
• Root Canal Treatment

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