Clinical trial NCT05840783: Evaluation of Post Operative Pain After Sonic Activation and Different Irrigation Needles During Root Canal Treatment
Official title: Comparative Evaluation of Postoperative Pain After Using Endoactivator, Side Vented and Open Ended Endodontic Needles as Final Irrigation Protocols During Root Canal Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Keywords: sonic activation
post operative pain
endoactivator
side vented needle
root canal therapy
irrigation
Lead sponsor: Armed Forces Institute of Dentistry, Pakistan
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study compares the post operative pain after root canal therapy, after using different irrigation protocols. The subjects are divided into 3 groups and different irrigation protocol is used in each group. One group undergoes final irrigation after root canal therapy with a sonic activation device, and in the other two groups, side-vented and open-ended needles are used. 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. Sonic 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, irrigation needles also play an important role in endodontic therapy, particularly by improving the delivery of irrigation agent to the apex of a root canal. conventionally, open ended needles have been used for irrigant delivery inside root canal but is not deemed very efficacious as they cannot penetrate deep into canals and cause extrusion of debris beyond the apex. This problem is solved by using side vented needles of smaller gauge (30 G) that leads to better irrigation and prevent extrusion of chemicals and debris outside the root apex.

In this study, the efficacy of all three different irrigation protocols will be compared and assessed based on post-operative pain, measured by Visual Analog Scale (VAS).

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 12 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

Primary outcomes:
measure: Post Operative pain assessed by VAS after endodontic therapy
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed Forces Institute of dentistry
state: Punjab
Study officials:
affiliation: Classified Specialist
name: Athar Ali, BDS
role: STUDY_DIRECTOR
References: