Evaluation of Post Operative Pain After Ultrasonic Activation and Manual Dynamic Agitation As Final Irrigation Protocols During Root Canal Treatment

NCT ID: NCT05852444

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-02-25

Brief Summary

The study analyzes the difference in post operative pain after root canal therapy, after using different activation protocols and devices. The subjects are divided into 2 groups and a different activation protocol is used in each group. In one group, final activation of irrigating agent during root canal therapy is done with an ultrasonic activation device, and in the other group, manual dynamic agitation is done using master gutta percha cone. The 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. Ultrasonic 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, a conventional method of agitation (manual dynamic agitation) also play an important role in endodontic therapy, particularly by improving the delivery of irrigation agent to the apex of a root canal. The later method involves agitation of irrigant with master gutta percha cone with continuous to and fro strokes manually.

In this study, the efficacy of both the 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

Manual Dynamic Agitation Group: Irrigation in this group shall be done using a master gutta percha cone during root canal therapy

Group Type: EXPERIMENTAL

Manual Dynamic Agitation

Intervention Type: DEVICE

Agitation of root canal irrigation solution with master gutta percha cone

Group B

Passive Ultrasonic Activation Group: In this group, final activation during endodontic therapy shall be done using an ultrasonic activation device (Ultra X)

Group Type: EXPERIMENTAL

Passive Ultrasonic Activation

Intervention Type: DEVICE

Agitation of root canal irrigation solution with an ultrasonic activation device (Ultra X).

Interventions

Passive Ultrasonic Activation

Agitation of root canal irrigation solution with an ultrasonic activation device (Ultra X).

Intervention Type: DEVICE

Manual Dynamic Agitation

Agitation of root canal irrigation solution with master gutta percha cone

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 6 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

Locations

Armed Forces Institute of dentistry

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

Ultrasonic Activation

Identifier Type: -

Identifier Source: org_study_id