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

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Sonic activation
side vented needle irrigation
open ended needle irrigation
Sponsored by
Armed Forces Institute of Dentistry, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain focused on measuring sonic activation, post operative pain, endoactivator, side vented needle, root canal therapy, irrigation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Armed Forces Institute of dentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 5, 2023
Last Updated
September 16, 2023
Sponsor
Armed Forces Institute of Dentistry, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT05840783
Brief Title
Evaluation of Post Operative Pain After Sonic Activation and Different Irrigation Needles During Root Canal Treatment
Acronym
Endoactivator
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Armed Forces Institute of Dentistry, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
sonic activation, post operative pain, endoactivator, side vented needle, root canal therapy, irrigation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Sonic activation group. In this group, final irrigation during endodontic therapy shall be done using a sonic activation device (Endoactivator)
Arm Title
Group B
Arm Type
Experimental
Arm Description
Side vented needle group. Irrigation in this group shall be done using a 30G side-vented needle during root canal therapy
Arm Title
Group C
Arm Type
Experimental
Arm Description
Open ended needle group. Irrigation in this group shall be done using a conventional open-ended needle during root canal therapy
Intervention Type
Device
Intervention Name(s)
Sonic activation
Intervention Description
Agitation of root canal irrigation solution with a sonic activation device (Endoactivator).
Intervention Type
Device
Intervention Name(s)
side vented needle irrigation
Intervention Description
irrigation during root canal shaping and cleaning using a 30-guage side-vented needle
Intervention Type
Device
Intervention Name(s)
open ended needle irrigation
Intervention Description
irrigation during root canal shaping and cleaning using an open-ended needle
Primary Outcome Measure Information:
Title
Post Operative pain assessed by VAS after endodontic therapy
Description
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
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdullah, BDS
Phone
00923365747574
Email
ahmedcmh6@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athar Ali, BDS
Organizational Affiliation
Classified Specialist
Official's Role
Study Director
Facility Information:
Facility Name
Armed Forces Institute of dentistry
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
64000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdullah, BDS
Phone
00923365747574
Email
ahmedcmh6@gmail.com

12. IPD Sharing Statement

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

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