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

NCT05852444 | Completed DMC

• 1 other identifier: Ultrasonic Activation
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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

Interventions

Passive Ultrasonic Activation DEVICE

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

Group B

Manual Dynamic Agitation DEVICE

Agitation of root canal irrigation solution with master gutta percha cone

Group A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unremarkable/ noncontributory medical history
• Healthy persons between the ages of 18 and 60 years
• Maxillary and mandibular molar teeth diagnosed with symptomatic irreversible pulpitis.
• Patients not having taken any medication for 6 hours before treatment
• No allergies to the drugs or dental material being used in the treatment

You may not qualify if:

• Patients who had taken analgesics on anti-inflammatory drugs within the last 12 hours
• Pregnant women and patients with immunocompromised health state
• Patients having severe malocclusion associated with traumatic occlusion
• Teeth with calcified canals
• Teeth with periapical radiolucency
• Teeth with root resorption
• Teeth previously undergone root canal treatment

Sponsors & Collaborators

• Armed Forces Institute of Dentistry, Pakistan: lead

Study Sites (1)

Armed Forces Institute of dentistry

Rawalpindi, Punjab Province, 64000, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants of the study and outcomes assessor would not know the details of groups, and only the investigator and care provider would be aware of that, as they cannot be blinded due to the nature of this study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar Operative Dentistry and Endodontics

Model Details: Participants to be divided into 2 different groups randomly, and intervention protocol to be performed as per group designation

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: May 1, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 25, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

PA (1)