Evaluation of Post Operative Pain After Sonic Activation and Different Irrigation Needles During Root Canal Treatment

Post Operative Pain Clinical Trial

— Endoactivator  

Official title:

Comparative Evaluation of Postoperative Pain After Using Endoactivator, Side Vented and Open Ended Endodontic Needles as Final Irrigation Protocols During Root Canal Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05840783
• Other study ID #: Sonic activation
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: February 4, 2024

Study information

• Verified date: February 2024
• Source: Armed Forces Institute of Dentistry, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study compares the post operative pain after root canal therapy, after using different irrigation protocols. The subjects are divided into 3 groups and different irrigation protocol is used in each group. One group undergoes final irrigation after root canal therapy with a sonic activation device, and in the other two groups, side-vented and open-ended needles are used. Post operative pain is then compared at 8, 24, and 48 hour intervals.

Description:

Root canal therapy is a procedure in which inflamed pulp tissue and microorganisms are removed from root canals and pulp chamber, in order to eradicate infection and symptoms. Irrigation is a crucial step of an endodontic therapy and different methods and protocols are used to enhance the efficacy of irrigation. Sonic activation of root canal irrigation agent is one of the effective methods that enhance the outcomes and success rate of endo therapies. It removes the smear layer, bacterial biofilms and debris by acoustic streaming and agitating the irrigant inside root canals. Similarly, irrigation needles also play an important role in endodontic therapy, particularly by improving the delivery of irrigation agent to the apex of a root canal. conventionally, open ended needles have been used for irrigant delivery inside root canal but is not deemed very efficacious as they cannot penetrate deep into canals and cause extrusion of debris beyond the apex. This problem is solved by using side vented needles of smaller gauge (30 G) that leads to better irrigation and prevent extrusion of chemicals and debris outside the root apex.

In this study, the efficacy of all three different irrigation protocols will be compared and assessed based on post-operative pain, measured by Visual Analog Scale (VAS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: February 4, 2024
• Est. primary completion date: February 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients with unremarkable/ noncontributory medical history

2. Healthy persons between the ages of 18 and 60 years

3. Maxillary and mandibular molar teeth diagnosed with symptomatic irreversible pulpitis.

4. Patients not having taken any medication for 12 hours before treatment

5. No allergies to the drugs or dental material being used in the treatment

Exclusion Criteria:

1. Patients who had taken analgesics on anti-inflammatory drugs within the last 12 hours

2. Pregnant women and patients with immunocompromised health state

3. Patients having severe malocclusion associated with traumatic occlusion

4. Teeth with calcified canals

5. Teeth with periapical radiolucency

6. Teeth with root resorption

7. Teeth previously undergone root canal treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Device:
• Open ended needle irrigation
irrigation during root canal shaping and cleaning using an open-ended needle
• side vented needle irrigation
irrigation during root canal shaping and cleaning using a 30-guage side-vented needle
• Sonic activation
Agitation of root canal irrigation solution with a sonic activation device (Endoactivator).

Locations

Country	Name	City	State
Pakistan	Armed Forces Institute of dentistry	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Armed Forces Institute of Dentistry, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Operative pain assessed by VAS after endodontic therapy	comparative evaluation of post operative pain after using different irrigation devices, using VAS (Visual Analog Scale). It is drawn as a straight line of 10 inches and marked in numbers which show intensity of pain, from 0-10, with 0 being no pain at all to10 being the worst pain imaginable. In detail, it is a scale which shows pain intensity in ascending order and can also be used to analyze the intensity of pain experienced by the patient.; 0: No pain at all 1-3: mild pain 4-6: moderate pain 7-9: severe pain 10: worst pain imaginable	1 week