Evaluation of Post Operative Pain After Sonic Activation and Different Irrigation Needles During Root Canal Treatment

NCT05840783 | Completed DMC FDA Device

• 1 other identifier: Sonic activation
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

sonic activation; post operative pain; endoactivator; side vented needle; root canal therapy; irrigation

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 (3)

Group A - Open-ended needle

EXPERIMENTAL

Open ended needle group. Irrigation in this group shall be done using a conventional open-ended needle during root canal therapy

Device: Open ended needle irrigation

Group B- side-vented needle

EXPERIMENTAL

Side vented needle group. Irrigation in this group shall be done using a 30G side-vented needle during root canal therapy

Device: side vented needle irrigation

Group C- Endoactivator

EXPERIMENTAL

Sonic activation group. In this group, final irrigation during endodontic therapy shall be done using a sonic activation device (Endoactivator)

Device: Sonic activation

Interventions

Open ended needle irrigation DEVICE

irrigation during root canal shaping and cleaning using an open-ended needle

Group A - Open-ended needle

side vented needle irrigation DEVICE

irrigation during root canal shaping and cleaning using a 30-guage side-vented needle

Group B- side-vented needle

Sonic activation DEVICE

Agitation of root canal irrigation solution with a sonic activation device (Endoactivator).

Group C- Endoactivator

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 12 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 Officials

• Athar Ali, BDS

  Classified Specialist

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients to be divided randomly into three groups after fulfilling the Inclusion Criteria, and not told about the specific intervention being done. Care provider/investigator knows which device they are using, while outcomes accessor is also masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar Operative Dentistry and Endodontics

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 3, 2023
• Study Start: April 1, 2023
• Primary Completion: February 4, 2024
• Study Completion: February 4, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

PA (1)