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

NCT ID: NCT05840783

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-02-04

Brief 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.

Detailed 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).

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group A - Open-ended needle

Open ended needle group. Irrigation in this group shall be done using a conventional open-ended needle during root canal therapy

Group Type: EXPERIMENTAL

Open ended needle irrigation

Intervention Type: DEVICE

irrigation during root canal shaping and cleaning using an open-ended needle

Group B- side-vented needle

Side vented needle group. Irrigation in this group shall be done using a 30G side-vented needle during root canal therapy

Group Type: EXPERIMENTAL

side vented needle irrigation

Intervention Type: DEVICE

irrigation during root canal shaping and cleaning using a 30-guage side-vented needle

Group C- Endoactivator

Sonic activation group. In this group, final irrigation during endodontic therapy shall be done using a sonic activation device (Endoactivator)

Group Type: EXPERIMENTAL

Sonic activation

Intervention Type: DEVICE

Agitation of root canal irrigation solution with a sonic activation device (Endoactivator).

Interventions

Open ended needle irrigation

irrigation during root canal shaping and cleaning using an open-ended needle

Intervention Type: DEVICE

side vented needle irrigation

irrigation during root canal shaping and cleaning using a 30-guage side-vented needle

Intervention Type: DEVICE

Sonic activation

Agitation of root canal irrigation solution with a sonic activation device (Endoactivator).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Armed Forces Institute of Dentistry, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdullah

Registrar Operative Dentistry and Endodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Athar Ali, BDS

Role: STUDY_DIRECTOR

Classified Specialist

Locations

Armed Forces Institute of dentistry

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Sonic activation

Identifier Type: -

Identifier Source: org_study_id