NCT07526844

Impact of Two Different Preparation Systems and Two Different Canal Sealers on Postoperative Pain After Root Canal Treatment

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: European University of Lefke · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the effect of root canal shaping using the TruNatomy and ProTaper Gold file systems in combination with AH Plus and TotalFill BC sealers on postoperative pain in patients with asymptomatic irreversible pulpitis. In addition, the potential interaction between the preparation system and the root canal sealer will be evaluated to determine whether specific combinations of file systems and sealers influence postoperative pain. By comparing these commonly used endodontic file systems and sealers, the study seeks to provide evidence-based guidance for optimizing endodontic protocols and improving patient comfort. The null hypotheses of this study are that the rotary file systems and the root canal sealers used do not have a statistically significant effect on postoperative pain. Postoperative pain will be assessed at different time intervals-6, 12, 24, 48, and 72 hours, as well as on the 7th day-using the Numerical Rating Scale (NRS). The NRS is the numerical version of the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (unbearable pain) (9, 10). It will be explained to participants as follows: 0: No pain Mild pain (1-3): Low-level pain that does not require analgesics Moderate pain (4-6): Tolerable pain that can be controlled with analgesics Severe pain (7-10): Unbearable pain that is not adequately controlled by analgesics and often requires rest

Conditions

• Irriversible Pulpitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-07-01
• Completion: 2027-10-30
• First posted: 2026-04-13
• Last updated: 2026-04-13