Bacterial Count Reduction in Oval Canal After Rotary Instrumentation With Different SystemsNCT07019792
Postoperative Pain and Bacterial Reduction in Oval Canals After Instrumentation With Different Noval Rotary Files Systems
A study testing Protaper ultimate, Truanatomy file system and Hyflex EDM in people with Bacterial Count Reduction in Oval Canal After Rotary Instrumentation With Different Systems and Post-operative Pain After Rotary Instrumentation of Oval Canal With Different Systems, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
Postoperative pain after endodontic treatment can affect a patient's quality of life. It is reported that debris extrusion after the instrumentation technique can influence postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Count Reduction in Oval Canal After Rotary Instrumentation With Different Systems, Post-operative Pain After Rotary Instrumentation of Oval Canal With Different Systems
- What is being tested?
- Protaper ultimate, Truanatomy file system and Hyflex EDM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteJordan
- Study dates
- 1 Oct 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Medically fit
- Age ranges from 18-65 year
- Restorable teeth
- Necrotic teeth and symptoms free
- Lower premolars teeth (single canal posterior teeth)
- Necrotic pulps
Who cannot join
- Medically compromised
- Non-restorable teeth
- Open apex canal
- The past 12-hour history of analgesic intake before treatment.
- Patients with a history of antibiotics intake in the last 3 months before treatment.
- Pregnant females.
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- Symptomatic patient.
- Pulpal diagnosis is not necrotic pulp.
- Retreatment cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Rotary Files Systems on Post-operative Pain and Bacterial Reduction in Lower Single Canal Posterior Teeth With Necrotic Pulp: Prospective Double Blinded Clinical Trial
Postoperative pain after endodontic treatment can affect a patient's quality of life. It is reported that debris extrusion after the instrumentation technique can influence postoperative pain. As a result, the aim of this clinical trial is to compare the recent rotary systems (TruNatomy, ProTaper Ultimate, Hyflex EDM and XP- rise rotary files systems) in terms of apical extrusion defined by post-operative pain and their role in reducing the bacterial count inside the canal
Read the detailed description
One hundred and twenty lower premolar teeth will be included in the study(n=120). Teeth will be randomly assigned to one of the 4 groups(n=30). Preoprative pain will be recorded before root canal treatment. Postoperative pain will be recorded using visual analogue scale (VAS) at 6 hours,12 hours, 1day, 2 days, 3 days, 4 dayse and five days after the root canal treatment. Bacterial count before and after instrumentation will be determined using culturing methods to determine the bacterial count reduction.
- Conditions
- Bacterial Count Reduction in Oval Canal After Rotary Instrumentation With Different Systems, Post-operative Pain After Rotary Instrumentation of Oval Canal With Different Systems
- Being tested
- Protaper ultimate, Truanatomy file system, Hyflex EDM, Xp shaper rise
- Keywords
- post operative pain, Protaper Ultimate, Hyflex EDM, XP rsie, TruNatomy, Bacterial, Oval canal
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protaper ultimateOther
Using Protaper Ultimate file system for canal preperation
Truanatomy file systemOther
Using Truanatomy file system for canal preperation
Hyflex EDMOther
Using Hyflex file system for canal preperation
Xp shaper riseOther
Using XPshaper rise system for canal preperation
| Study group | Role | What they receive |
|---|---|---|
| Multifile system: Protaper Ultimate | Experimental | Not described Receives: Other: Protaper ultimate |
| Multiple files systems:TruNatomy | Experimental | Not described Receives: Other: Truanatomy file system |
| Single file system: Hyflex EDM | Experimental | Not described Receives: Other: Hyflex EDM |
| Single file system: Xp shaper rise | Experimental | Not described Receives: Other: Xp shaper rise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain will be recorded using Visual Analogue Scale (VAS) at 6hours,12 hours, 24 hours, 2 days, 3 days, 4 days and five days after the root canal treatment Visual Analogue Scale (VAS) ranges from 0-10, the lower number the better outcome.
0= no pain 1-3= mild pain 4-6= moderate pain 7-10= sever pain
Measured: at 6hours,12 hours, 24 hours, 2 days, 3 days, 4 days and five days after the root canal treatment
Bacterial count reduction
Bacterial count sample will be collected before and after canal prepeartion
Measured: Sample will be collected before and directly after canal prepeartion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Oct 2024
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Count Reduction in Oval Canal After Rotary Instrumentation With Different SystemsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Principal investigator, Ruba Mustafa, King Abdullah University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019792
- Sponsor's protocol ID
- 20230408
- Other IDs
- 20230408
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Rotary Files Systems on Post-operative Pain and Bacterial Reduction in Lower Single Canal Posterior Teeth With Necrotic Pulp: Prospective Double Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT07019792
- Acronym / sponsor ID
- 20230408
- Conditions
- Bacterial Count Reduction in Oval Canal After Rotary Instrumentation With Different Systems, Post-operative Pain After Rotary Instrumentation of Oval Canal With Different Systems
- Keywords
- post operative pain, Protaper Ultimate, Hyflex EDM, XP rsie, TruNatomy, Bacterial, Oval canal
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 13 Jun 2025 (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.
Postoperative pain after endodontic treatment can affect a patient's quality of life. It is reported that debris extrusion after the instrumentation technique can influence postoperative pain. As a result, the aim of this clinical trial is to compare the recent rotary systems (TruNatomy, ProTaper Ultimate, Hyflex EDM and XP- rise rotary files systems) in terms of apical extrusion defined by post-operative pain and their role in reducing the bacterial count inside the canal
Detailed description
One hundred and twenty lower premolar teeth will be included in the study(n=120). Teeth will be randomly assigned to one of the 4 groups(n=30). Preoprative pain will be recorded before root canal treatment. Postoperative pain will be recorded using visual analogue scale (VAS) at 6 hours,12 hours, 1day, 2 days, 3 days, 4 dayse and five days after the root canal treatment. Bacterial count before and after instrumentation will be determined using culturing methods to determine the bacterial count reduction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Multifile system: Protaper Ultimate | Experimental | Other: Protaper ultimate |
| Multiple files systems:TruNatomy | Experimental | Other: Truanatomy file system |
| Single file system: Hyflex EDM | Experimental | Other: Hyflex EDM |
| Single file system: Xp shaper rise | Experimental | Other: Xp shaper rise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Medically fit
- Age ranges from 18-65 year
- Restorable teeth
- Necrotic teeth and symptoms free
- Lower premolars teeth (single canal posterior teeth)
Key exclusion criteria (9 listed)
- Medically compromised
- Non-restorable teeth
- Open apex canal
- The past 12-hour history of analgesic intake before treatment.
- Patients with a history of antibiotics intake in the last 3 months before treatment.
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 |
|---|---|---|
| Protaper ultimateUsing Protaper Ultimate file system for canal preperation | Other | Multifile system: Protaper Ultimate |
| Truanatomy file systemUsing Truanatomy file system for canal preperation | Other | Multiple files systems:TruNatomy |
| Hyflex EDMUsing Hyflex file system for canal preperation | Other | Single file system: Hyflex EDM |
| Xp shaper riseUsing XPshaper rise system for canal preperation | Other | Single file system: Xp shaper rise |
Primary outcome
Postoperative pain
Time frame: at 6hours,12 hours, 24 hours, 2 days, 3 days, 4 days and five days after the root canal treatment
Postoperative pain will be recorded using Visual Analogue Scale (VAS) at 6hours,12 hours, 24 hours, 2 days, 3 days, 4 days and five days after the root canal treatment Visual Analogue Scale (VAS) ranges from 0-10, the lower number the better outcome. 0= no pain 1-3= mild pain 4-6= moderate pain 7-10= sever pain
Bacterial count reduction
Time frame: Sample will be collected before and directly after canal prepeartion
Bacterial count sample will be collected before and after canal prepeartion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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 Protaper ultimate, Truanatomy file system and Hyflex EDM in people with Bacterial Count Reduction in Oval Canal After Rotary Instrumentation With Different Systems and Post-operative Pain After Rotary Instrumentation of Oval Canal With Different Systems, run by King Abdullah University Hospital at 1 site in Jordan.
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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2025. 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 Jordan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Postoperative pain (time frame: at 6hours,12 hours, 24 hours, 2 days, 3 days, 4 days and five days after the root canal treatment). The study lists 2 primary outcomes in all. 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 17 Jun 2025.