Post Operative PainEndoactivatorNCT05840783
Evaluation of Post Operative Pain After Sonic Activation and Different Irrigation Needles During Root Canal Treatment
A study testing Open ended needle irrigation, side vented needle irrigation and Sonic activation in people with Post Operative Pain, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Open ended needle irrigation, side vented needle irrigation and Sonic activation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 4 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed Forces Institute of dentistry
Rawalpindi, Punjab Province, 64000
About this study
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
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.
Read the 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).
- Conditions
- Post Operative Pain
- Being tested
- Open ended needle irrigation, side vented needle irrigation, Sonic activation
- Keywords
- sonic activation, post operative pain, endoactivator, side vented needle, root canal therapy, irrigation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open ended needle irrigationDevice
irrigation during root canal shaping and cleaning using an open-ended needle
side vented needle irrigationDevice
irrigation during root canal shaping and cleaning using a 30-guage side-vented needle
Sonic activationDevice
Agitation of root canal irrigation solution with a sonic activation device (Endoactivator).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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) Receives: Device: Sonic activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Apr 2023
- Primary completion4 Feb 2024
- Study completion4 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdullah, Armed Forces Institute of Dentistry, Pakistan
- Investigators
- Athar Ali, BDS, Study director, Classified Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840783
- Sponsor's protocol ID
- Sonic activation
- Acronym
- Endoactivator
- Status last verified
- Feb 2024
- First submitted
- 5 Apr 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05840783
- Acronym / sponsor ID
- Endoactivator / Sonic activation
- Conditions
- Post Operative Pain
- Keywords
- sonic activation, post operative pain, endoactivator, side vented needle, root canal therapy, irrigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 4 Feb 2024 (actual)
- Study completion
- 4 Feb 2024 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - Open-ended needle | Experimental | Device: Open ended needle irrigationOpen ended needle group. Irrigation in this group shall be done using a conventional open-ended needle during root canal therapy |
| Group B- side-vented needle | Experimental | Device: side vented needle irrigationSide vented needle group. Irrigation in this group shall be done using a 30G side-vented needle during root canal therapy |
| Group C- Endoactivator | Experimental | Device: Sonic activationSonic activation group. In this group, final irrigation during endodontic therapy shall be done using a sonic activation device (Endoactivator) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open ended needle irrigationirrigation during root canal shaping and cleaning using an open-ended needle | Device | Group A - Open-ended needle |
| side vented needle irrigationirrigation during root canal shaping and cleaning using a 30-guage side-vented needle | Device | Group B- side-vented needle |
| Sonic activationAgitation of root canal irrigation solution with a sonic activation device (Endoactivator). | Device | Group C- Endoactivator |
Primary outcome
Post Operative pain assessed by VAS after endodontic therapy
Time frame: 1 week
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athar Ali, BDS study director
Classified Specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open ended needle irrigation, side vented needle irrigation and Sonic activation in people with Post Operative Pain, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative pain assessed by VAS after endodontic therapy (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.