Irriversible PulpitisPOPNCT07526844
Effect of Instrumentation Systems and Sealers on Postoperative Pain
A study testing TruNatomy, ProTaper Gold and AH Plus in people with Irriversible Pulpitis, run by European University of Lefke.
Trial summary
The goal of this randomized clinical trial is to evaluate whether different root canal preparation systems and sealer types affect postoperative pain after root canal treatment in adult patients (18-60 years) with asymptomatic irreversible pulpitis in mandibular premolars. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irriversible Pulpitis
- What is being tested?
- TruNatomy, ProTaper Gold and AH Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 30 Oct 2027
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Asymptomatic teeth with delayed positive response to thermal and electric pulp testing
- Vital teeth with signs of irreversible pulpitis
- Mature mandibular first or second premolars
- Periodontally healthy teeth Exclusion Criteria
- Patients with systemic conditions (e.g., diabetes, immunocompromised status, pregnancy)
- Antibiotic use within the past month
Show all 12Show fewer
- Use of analgesics within 7 days prior to treatment
- Known allergy to materials used
- Teeth with periapical lesions
- Non-vital or symptomatic teeth
- Teeth requiring post-core restorations
- Calcified canals, root resorption, or immature teeth
Who cannot join
None listed.
About this study
Official title: Impact of TruNatomy and ProTaper Gold Ni-Ti Systems Using Resin-based or Bioceramic Sealers on Postoperative Pain After Root Canal Treatment: a Randomized Clinical Trial
The goal of this randomized clinical trial is to evaluate whether different root canal preparation systems and sealer types affect postoperative pain after root canal treatment in adult patients (18-60 years) with asymptomatic irreversible pulpitis in mandibular premolars.
The main questions it aims to answer are:
Read more
Do different instrumentation systems (TruNatomy vs ProTaper Gold) influence postoperative pain levels? Do different sealer types (AH Plus vs TotalFill BC) affect postoperative pain and analgesic consumption? Researchers will compare TruNatomy and ProTaper Gold systems combined with AH Plus or TotalFill BC sealers to determine their effect on postoperative pain.
Participants will:
Undergo single-visit root canal treatment using one of the assigned file system and sealer combinations Record their pain levels using a Numerical Rating Scale (NRS) at specific time intervals (6, 12, 24, 48, 72 hours, and 7 days) Take ibuprofen only if needed and record analgesic intake Attend a follow-up visit on the 7th day
Read the detailed description
Postoperative pain remains a significant concern in endodontic treatment, even in cases of asymptomatic irreversible pulpitis. Although root canal therapy is highly effective, patients may experience discomfort due to mechanical, chemical, or microbial irritation of periapical tissues during treatment. Among these factors, the type of instrumentation system and root canal sealer may influence the degree of postoperative pain through their effects on debris extrusion, canal shaping characteristics, and biological tissue response.
Minimally invasive instrumentation systems have been introduced to preserve dentin structure and maintain the original canal anatomy. TruNatomy (Dentsply Maillefer) is designed with a slim Ni-Ti wire and regressive taper, aiming to reduce canal transportation and minimize apical extrusion of debris. In contrast, ProTaper Gold (Dentsply Maillefer) features a progressive taper and enhanced cutting efficiency, which may improve shaping ability but could potentially increase the extrusion of debris beyond the apex.
In addition to instrumentation, the chemical composition and biological properties of root canal sealers may influence postoperative outcomes. AH Plus, an epoxy resin-based sealer, demonstrates strong adhesion and dimensional stability. TotalFill BC Sealer, a calcium silicate-based bioceramic material, is characterized by high biocompatibility and bioactivity, including calcium ion release, which may promote favorable tissue response.
This study is designed as a prospective, randomized clinical trial with a factorial structure to evaluate both the independent and combined effects of instrumentation systems and sealer types on postoperative pain. The interaction between these variables will also be assessed to determine whether specific combinations are associated with increased or reduced pain levels.
All treatments will be performed under standardized clinical conditions using a single-visit protocol, with consistent irrigation regimens and obturation techniques to minimize confounding variables. Pain intensity will be recorded at multiple postoperative time points using a validated numerical scale, allowing evaluation of both the intensity and temporal pattern of pain.
The findings of this study are expected to provide clinically relevant evidence regarding the selection of instrumentation systems and root canal sealers to optimize patient comfort following endodontic treatment.
- Conditions
- Irriversible Pulpitis
- Being tested
- TruNatomy, ProTaper Gold, AH Plus, TotalFill BC
- Keywords
- Post Operative Pain, Irreversible Pulpitis, NiTi File, Canal Sealer
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruNatomyDevice
Rotary nickel-titanium (NiTi) endodontic file system used for root canal shaping with minimally invasive design. Instrumentation performed according to manufacturer instructions.
ProTaper GoldDevice
Heat-treated rotary nickel-titanium (NiTi) endodontic file system used for root canal shaping following manufacturer-recommended protocol.
AH PlusOther
Epoxy resin-based root canal sealer used for obturation with gutta-percha using a single-cone technique.
TotalFill BCOther
Calcium silicate-based bioceramic root canal sealer used for obturation with gutta-percha using a single-cone technique.
| Study group | Role | What they receive |
|---|---|---|
| TruNatomy + AH Plus | Experimental | Name: TruNatomy + AH Plus Type: Experimental
Intervention:
Device: TruNatomy file system Other: AH Plus sealer Receives: Device: TruNatomy; Other: AH Plus |
| TruNatomy + TotalFill BC | Experimental | Name: TruNatomy + TotalFill BC Type: Experimental
Intervention:
Device: TruNatomy Other: TotalFill BC Receives: Device: TruNatomy; Other: TotalFill BC |
| ProTaper Gold + AH Plus | Experimental | Name: ProTaper Gold + AH Plus Type: Experimental
Intervention:
Device: ProTaper Gold Other: AH Plus Receives: Device: ProTaper Gold; Other: AH Plus |
| ProTaper Gold + TotalFill BC | Experimental | Name: ProTaper Gold + TotalFill BC Type: Experimental
Intervention:
Device: ProTaper Gold Other: TotalFill BC Receives: Device: ProTaper Gold; Other: TotalFill BC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity (Numerical Rating Scale)
Postoperative pain will be assessed using a Numerical Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain. Patients will record pain levels at 6, 12, 24, 48, and 72 hours, and on day 7 following root canal treatment.
Measured: 6, 12, 24, 48, 72 hours and 7 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irriversible PulpitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European University of Lefke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Abduljalil, European University of Lefke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526844
- Sponsor's protocol ID
- BAYEK057.03
- Other IDs
- BAPKO0442620
- Acronym
- POP
- Status last verified
- Sep 2026
- First submitted
- 7 Apr 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of TruNatomy and ProTaper Gold Ni-Ti Systems Using Resin-based or Bioceramic Sealers on Postoperative Pain After Root Canal Treatment: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07526844
- Acronym / sponsor ID
- POP / BAYEK057.03
- Conditions
- Irriversible Pulpitis
- Keywords
- Post Operative Pain, Irreversible Pulpitis, NiTi File, Canal Sealer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- European University of LefkeUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 13 Apr 2026 (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 goal of this randomized clinical trial is to evaluate whether different root canal preparation systems and sealer types affect postoperative pain after root canal treatment in adult patients (18-60 years) with asymptomatic irreversible pulpitis in mandibular premolars.
The main questions it aims to answer are:
Do different instrumentation systems (TruNatomy vs ProTaper Gold) influence postoperative pain levels? Do different sealer types (AH Plus vs TotalFill BC) affect postoperative pain and analgesic consumption? Researchers will compare TruNatomy and ProTaper Gold systems combined with AH Plus or TotalFill BC sealers to determine their effect on postoperative pain.
Participants will:
Undergo single-visit root canal treatment using one of the assigned file system and sealer combinations Record their pain levels using a Numerical Rating Scale (NRS) at specific time intervals (6, 12, 24, 48, 72 hours, and 7 days) Take ibuprofen only if needed and record analgesic intake Attend a follow-up visit on the 7th day
Detailed description
Postoperative pain remains a significant concern in endodontic treatment, even in cases of asymptomatic irreversible pulpitis. Although root canal therapy is highly effective, patients may experience discomfort due to mechanical, chemical, or microbial irritation of periapical tissues during treatment. Among these factors, the type of instrumentation system and root canal sealer may influence the degree of postoperative pain through their effects on debris extrusion, canal shaping characteristics, and biological tissue response.
Minimally invasive instrumentation systems have been introduced to preserve dentin structure and maintain the original canal anatomy. TruNatomy (Dentsply Maillefer) is designed with a slim Ni-Ti wire and regressive taper, aiming to reduce canal transportation and minimize apical extrusion of debris. In contrast, ProTaper Gold (Dentsply Maillefer) features a progressive taper and enhanced cutting efficiency, which may improve shaping ability but could potentially increase the extrusion of debris beyond the apex.
In addition to instrumentation, the chemical composition and biological properties of root canal sealers may influence postoperative outcomes. AH Plus, an epoxy resin-based sealer, demonstrates strong adhesion and dimensional stability. TotalFill BC Sealer, a calcium silicate-based bioceramic material, is characterized by high biocompatibility and bioactivity, including calcium ion release, which may promote favorable tissue response.
This study is designed as a prospective, randomized clinical trial with a factorial structure to evaluate both the independent and combined effects of instrumentation systems and sealer types on postoperative pain. The interaction between these variables will also be assessed to determine whether specific combinations are associated with increased or reduced pain levels.
All treatments will be performed under standardized clinical conditions using a single-visit protocol, with consistent irrigation regimens and obturation techniques to minimize confounding variables. Pain intensity will be recorded at multiple postoperative time points using a validated numerical scale, allowing evaluation of both the intensity and temporal pattern of pain.
The findings of this study are expected to provide clinically relevant evidence regarding the selection of instrumentation systems and root canal sealers to optimize patient comfort following endodontic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TruNatomy + AH Plus | Experimental | Device: TruNatomy, Other: AH PlusName: TruNatomy + AH Plus Type: Experimental Intervention: Device: TruNatomy file system Other: AH Plus sealer |
| TruNatomy + TotalFill BC | Experimental | Device: TruNatomy, Other: TotalFill BCName: TruNatomy + TotalFill BC Type: Experimental Intervention: Device: TruNatomy Other: TotalFill BC |
| ProTaper Gold + AH Plus | Experimental | Device: ProTaper Gold, Other: AH PlusName: ProTaper Gold + AH Plus Type: Experimental Intervention: Device: ProTaper Gold Other: AH Plus |
| ProTaper Gold + TotalFill BC | Experimental | Device: ProTaper Gold, Other: TotalFill BCName: ProTaper Gold + TotalFill BC Type: Experimental Intervention: Device: ProTaper Gold Other: TotalFill BC |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Asymptomatic teeth with delayed positive response to thermal and electric pulp testing
- Vital teeth with signs of irreversible pulpitis
- Mature mandibular first or second premolars
- Periodontally healthy teeth Exclusion Criteria
- Patients with systemic conditions (e.g., diabetes, immunocompromised status, pregnancy)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TruNatomyRotary nickel-titanium (NiTi) endodontic file system used for root canal shaping with minimally invasive design. Instrumentation performed according to manufacturer instructions. | Device | TruNatomy + AH Plus, TruNatomy + TotalFill BC |
| ProTaper GoldHeat-treated rotary nickel-titanium (NiTi) endodontic file system used for root canal shaping following manufacturer-recommended protocol. | Device | ProTaper Gold + AH Plus, ProTaper Gold + TotalFill BC |
| AH PlusEpoxy resin-based root canal sealer used for obturation with gutta-percha using a single-cone technique. | Other | ProTaper Gold + AH Plus, TruNatomy + AH Plus |
| TotalFill BCCalcium silicate-based bioceramic root canal sealer used for obturation with gutta-percha using a single-cone technique. | Other | ProTaper Gold + TotalFill BC, TruNatomy + TotalFill BC |
Primary outcome
Postoperative Pain Intensity (Numerical Rating Scale)
Time frame: 6, 12, 24, 48, 72 hours and 7 days post-treatment
Postoperative pain will be assessed using a Numerical Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain. Patients will record pain levels at 6, 12, 24, 48, and 72 hours, and on day 7 following root canal treatment.
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 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Irriversible Pulpitis
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Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers
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Comparison of Sodium Hypochlorite Gel and Solution With and Without Nanoparticles for Postoperative Pain After Pulpotomy in Permanent Mandibular Molars
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Not yet recruiting
Comparison of Post-operative Pain After Different Root Canal Irrigant Activation Methods
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TruNatomy, ProTaper Gold and AH Plus in people with Irriversible Pulpitis, run by European University of Lefke.
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 12 inclusion and 0 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: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Intensity (Numerical Rating Scale) (time frame: 6, 12, 24, 48, 72 hours and 7 days post-treatment). 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 11 Sep 2026.