Effect of Instrumentation Systems and Sealers on Postoperative Pain (POP)

April 15, 2026 updated by: Mohamad Abduljalil, European University of Lefke

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:

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TruNatomy + AH Plus

Name: TruNatomy + AH Plus Type: Experimental

Intervention:

Device: TruNatomy file system Other: AH Plus sealer
Device: TruNatomy
Rotary nickel-titanium (NiTi) endodontic file system used for root canal shaping with minimally invasive design. Instrumentation performed according to manufacturer instructions.
Other: AH Plus
Epoxy resin-based root canal sealer used for obturation with gutta-percha using a single-cone technique.
Experimental: TruNatomy + TotalFill BC

Name: TruNatomy + TotalFill BC Type: Experimental

Intervention:

Device: TruNatomy Other: TotalFill BC
Device: TruNatomy
Rotary nickel-titanium (NiTi) endodontic file system used for root canal shaping with minimally invasive design. Instrumentation performed according to manufacturer instructions.
Other: TotalFill BC
Calcium silicate-based bioceramic root canal sealer used for obturation with gutta-percha using a single-cone technique.
Experimental: ProTaper Gold + AH Plus

Name: ProTaper Gold + AH Plus Type: Experimental

Intervention:

Device: ProTaper Gold Other: AH Plus
Other: AH Plus
Epoxy resin-based root canal sealer used for obturation with gutta-percha using a single-cone technique.
Device: ProTaper Gold
Heat-treated rotary nickel-titanium (NiTi) endodontic file system used for root canal shaping following manufacturer-recommended protocol.
Experimental: ProTaper Gold + TotalFill BC

Name: ProTaper Gold + TotalFill BC Type: Experimental

Intervention:

Device: ProTaper Gold Other: TotalFill BC
Other: TotalFill BC
Calcium silicate-based bioceramic root canal sealer used for obturation with gutta-percha using a single-cone technique.
Device: ProTaper Gold
Heat-treated rotary nickel-titanium (NiTi) endodontic file system used for root canal shaping following manufacturer-recommended protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6, 12, 24, 48, 72 hours and 7 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European University of Lefke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAYEK057.03
  • BAPKO0442620 (Other Grant/Funding Number: European University of Lefke)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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