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

Comparison of Postoperative Pain After Using Passive Ultra Sonic Activation (PUA) and Manual Dynamic Agitation (MDA) During Root Canal Treatment

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

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Device: Passive Ultrasonic Activation; Device: Manual Dynamic Agitation

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Abdullah, BDS; Phone Number: 00923365747574; Email: ahmedcmh6@gmail.com
• Study Contact Backup: Name: Athar Ali, C Specialist; Phone Number: 00923365747574; Email: ahmedcmh6@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 64000
      • Armed Forces Institute of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Manual Dynamic Agitation Group: Irrigation in this group shall be done using a master gutta percha cone during root canal therapy	Device: Manual Dynamic Agitation; Agitation of root canal irrigation solution with master gutta percha cone
Experimental: Group B; Passive Ultrasonic Activation Group: In this group, final activation during endodontic therapy shall be done using an ultrasonic activation device (Ultra X)	Device: Passive Ultrasonic Activation; Agitation of root canal irrigation solution with an ultrasonic activation device (Ultra X).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Armed Forces Institute of Dentistry, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 25, 2024

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Ultrasonic Activation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No