search
Back to results

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

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Passive Ultrasonic Activation
Manual Dynamic Agitation
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

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 6 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 Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

Passive Ultrasonic Activation Group: In this group, final activation during endodontic therapy shall be done using an ultrasonic activation device (Ultra X)

Manual Dynamic Agitation Group: Irrigation in this group shall be done using a master gutta percha cone 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
May 2, 2023
Last Updated
September 16, 2023
Sponsor
Armed Forces Institute of Dentistry, Pakistan
search

1. Study Identification

Unique Protocol Identification Number
NCT05852444
Brief Title
Evaluation of Post Operative Pain After Ultrasonic Activation and Manual Dynamic Agitation As Final Irrigation Protocols During Root Canal Treatment
Acronym
Ultra X
Official Title
Comparison of Postoperative Pain After Using Passive Ultra Sonic Activation (PUA) and Manual Dynamic Agitation (MDA) During Root Canal Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 30, 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
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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
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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants to be divided into 2 different groups randomly, and intervention protocol to be performed as per group designation
Masking
ParticipantOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Passive Ultrasonic Activation Group: In this group, final activation during endodontic therapy shall be done using an ultrasonic activation device (Ultra X)
Arm Title
Group B
Arm Type
Experimental
Arm Description
Manual Dynamic Agitation Group: Irrigation in this group shall be done using a master gutta percha cone during root canal therapy
Intervention Type
Device
Intervention Name(s)
Passive Ultrasonic Activation
Intervention Description
Agitation of root canal irrigation solution with an ultrasonic activation device (Ultra X).
Intervention Type
Device
Intervention Name(s)
Manual Dynamic Agitation
Intervention Description
Agitation of root canal irrigation solution with master gutta percha cone
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 6 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
First Name & Middle Initial & Last Name or Official Title & Degree
Athar Ali, C Specialist
Phone
00923365747574
Email
ahmedcmh6@gmail.com
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

Learn more about this trial

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

We'll reach out to this number within 24 hrs