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

N/ANot Yet RecruitingNCT07526844

European University of Lefke144 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

144

Conditions

Irriversible Pulpitis

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Asymptomatic teeth showing a delayed positive response to thermal testing (EndoIce; Coltene/Whaledent Inc.) and electric pulp testing (Parkell) * Teeth with extensive pulp exposure during caries removal * Inflamed pulp tissue with bleeding that cannot be controlled within 5 minutes * Periodontally healthy, mature mandibular first or second premolar teeth Exclusion Criteria: Patients with the following conditions will be excluded from the study: * Patients with diabetes mellitus, immunocompromised conditions, or pregnancy * Patients who have used antibiotics within the last month or require antibiotic prophylaxis * Patients who have taken analgesics within 7 days prior to treatment * Patients with known allergies to any materials used in root canal treatment * Teeth with bleeding that can be controlled within 5 minutes and are suitable for vital pulp therapy * Teeth that are non-vital or symptomatic * Teeth with radiographically detectable periapical lesions * Teeth requiring post-core restoration or prosthetic support * Teeth with calcified root canals, root resorption, or immature apex

Outcomes

Primary Outcomes

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.

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