Post Operative PainUltra XNCT05852444
Evaluation of Post Operative Pain After Ultrasonic Activation and Manual Dynamic Agitation As Final Irrigation Protocols During Root Canal Treatment
A study testing Passive Ultrasonic Activation and Manual Dynamic Agitation in people with Post Operative Pain, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial 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. 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?
- Passive Ultrasonic Activation and Manual Dynamic Agitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2023to 25 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 6 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: Comparison of Postoperative Pain After Using Passive Ultra Sonic Activation (PUA) and Manual Dynamic Agitation (MDA) During Root Canal Treatment
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
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. 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).
- Conditions
- Post Operative Pain
- Being tested
- Passive Ultrasonic Activation, Manual Dynamic Agitation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Ultrasonic ActivationDevice
Agitation of root canal irrigation solution with an ultrasonic activation device (Ultra X).
Manual Dynamic AgitationDevice
Agitation of root canal irrigation solution with master gutta percha cone
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Manual Dynamic Agitation Group: Irrigation in this group shall be done using a master gutta percha cone during root canal therapy Receives: Device: Manual Dynamic Agitation |
| Group B | Experimental | Passive Ultrasonic Activation Group: In this group, final activation during endodontic therapy shall be done using an ultrasonic activation device (Ultra X) Receives: Device: Passive Ultrasonic 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 posted10 May 2023
- Study start1 May 2023
- Primary completion15 Feb 2024
- Study completion25 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
- Model description
- Participants to be divided into 2 different groups randomly, and intervention protocol to be performed as per group designation
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852444
- Sponsor's protocol ID
- Ultrasonic Activation
- Acronym
- Ultra X
- Status last verified
- Mar 2024
- First submitted
- 2 May 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain After Using Passive Ultra Sonic Activation (PUA) and Manual Dynamic Agitation (MDA) During Root Canal Treatment
- ClinicalTrials.gov ID
- NCT05852444
- Acronym / sponsor ID
- Ultra X / Ultrasonic Activation
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 10 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 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants to be divided into 2 different groups randomly, and intervention protocol to be performed as per group designation
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Manual Dynamic AgitationManual Dynamic Agitation Group: Irrigation in this group shall be done using a master gutta percha cone during root canal therapy |
| Group B | Experimental | Device: Passive Ultrasonic ActivationPassive Ultrasonic Activation Group: In this group, final activation during endodontic therapy shall be done using an ultrasonic activation device (Ultra X) |
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 6 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 |
|---|---|---|
| Passive Ultrasonic ActivationAgitation of root canal irrigation solution with an ultrasonic activation device (Ultra X). | Device | Group B |
| Manual Dynamic AgitationAgitation of root canal irrigation solution with master gutta percha cone | Device | Group A |
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 5 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Ultrasonic Activation and Manual Dynamic Agitation 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 5 Mar 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 5 Mar 2024.