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

Not Applicable

Completed

• Conditions: Post Operative Pain
• Interventions: Device: Passive Ultrasonic Activation; Device: Manual Dynamic Agitation

• Registration Number: NCT05852444
• Lead Sponsor: Armed Forces Institute of Dentistry, Pakistan

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).

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-10
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-02
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Passive Ultrasonic Activation	Passive Ultrasonic Activation Group: In this group, final activation during endodontic therapy shall be done using an ultrasonic activation device (Ultra X)
Group A	Manual Dynamic Agitation	Manual Dynamic Agitation Group: Irrigation in this group shall be done using a master gutta percha cone during root canal therapy

Primary Outcome Measures

Name	Time	Method
Post Operative pain assessed by VAS after endodontic therapy	1 week	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

Trial Locations

Locations (1)

Armed Forces Institute of dentistry; 🇵🇰 Rawalpindi, Punjab, Pakistan