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Effect of Instrumentation Systems and Sealers on Postoperative Pain

NCT07526844 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-04-21

No results posted yet for this study

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

Conditions

  • Irriversible Pulpitis

Interventions

DEVICE

TruNatomy

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

DEVICE

ProTaper Gold

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

OTHER

AH Plus

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

OTHER

TotalFill BC

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

Sponsors & Collaborators

  • European University of Lefke

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-07-01
Completion
2027-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07526844 on ClinicalTrials.gov