NCT07526844

Brief 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. 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2027

Last Updated

April 21, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

April 7, 2026

Last Update Submit

April 15, 2026

Conditions

Irriversible Pulpitis

Keywords

Post Operative PainIrreversible PulpitisNiTi FileCanal Sealer

Outcome Measures

Primary Outcomes (1)

  • 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.

    6, 12, 24, 48, 72 hours and 7 days post-treatment

Study Arms (4)

TruNatomy + AH Plus

EXPERIMENTAL

Name: TruNatomy + AH Plus Type: Experimental Intervention: Device: TruNatomy file system Other: AH Plus sealer

Device: TruNatomyOther: AH Plus

TruNatomy + TotalFill BC

EXPERIMENTAL

Name: TruNatomy + TotalFill BC Type: Experimental Intervention: Device: TruNatomy Other: TotalFill BC

Device: TruNatomyOther: TotalFill BC

ProTaper Gold + AH Plus

EXPERIMENTAL

Name: ProTaper Gold + AH Plus Type: Experimental Intervention: Device: ProTaper Gold Other: AH Plus

Device: ProTaper GoldOther: AH Plus

ProTaper Gold + TotalFill BC

EXPERIMENTAL

Name: ProTaper Gold + TotalFill BC Type: Experimental Intervention: Device: ProTaper Gold Other: TotalFill BC

Device: ProTaper GoldOther: TotalFill BC

Interventions

TruNatomyDEVICE

Rotary nickel-titanium (NiTi) endodontic file system used for root canal shaping with minimally invasive design. Instrumentation performed according to manufacturer instructions.

TruNatomy + AH PlusTruNatomy + TotalFill BC
ProTaper GoldDEVICE

Heat-treated rotary nickel-titanium (NiTi) endodontic file system used for root canal shaping following manufacturer-recommended protocol.

ProTaper Gold + AH PlusProTaper Gold + TotalFill BC
AH PlusOTHER

Epoxy resin-based root canal sealer used for obturation with gutta-percha using a single-cone technique.

ProTaper Gold + AH PlusTruNatomy + AH Plus
TotalFill BCOTHER

Calcium silicate-based bioceramic root canal sealer used for obturation with gutta-percha using a single-cone technique.

ProTaper Gold + TotalFill BCTruNatomy + TotalFill BC

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

epoxy resin-based root canal sealer

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr. Mohamad Abduljalil

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 13, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

October 30, 2027

Last Updated

April 21, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share