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

Post Operative Pain Clinical Trial

— Ultra X  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05852444
• Other study ID #: Ultrasonic Activation
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: February 25, 2024

Study information

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

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 25, 2024
• Est. primary completion date: February 15, 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 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Device:
• Passive Ultrasonic Activation
Agitation of root canal irrigation solution with an ultrasonic activation device (Ultra X).
• Manual Dynamic Agitation
Agitation of root canal irrigation solution with master gutta percha cone

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