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Comparison of WaveOne and ProTaper Systems on Postoperative Pain in Irreversible Pulpitis Patients

NCT07510490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2026-04-03

No results posted yet for this study

Summary

This study aims to compare two commonly used root canal instrumentation systems, WaveOne (reciprocating system) and ProTaper (rotary system), in patients diagnosed with symptomatic irreversible pulpitis. Root canal treatment is performed to remove inflamed pulp tissue, disinfect the canal, and relieve pain. However, some patients experience pain after the procedure, particularly within the first few days.

In this randomized controlled trial, 146 patients will be assigned to receive root canal treatment using either WaveOne or ProTaper instruments. All procedures will be performed under standardized clinical conditions by a single operator. Patients will be asked to record their pain levels using a Numerical Rating Scale (NRS) at specific time intervals after treatment, including 6, 12, 24, 48, and 72 hours, and at one week.

The purpose of this study is to determine whether one instrumentation system results in less postoperative pain compared to the other. The findings may help improve patient comfort and guide dentists in selecting the most appropriate root canal instrumentation technique.

Conditions

  • Symptomatic Irreversible Pulpitis

Interventions

DEVICE

WaveOne Reciprocating System

Root canal instrumentation performed using a single-file reciprocating nickel-titanium system following the manufacturer's recommended protocol. File selection is based on canal negotiation with hand K-files. The system uses a reciprocating motion to prepare the canal, aiming to reduce instrumentation time and debris extrusion. All procedures are carried out under standardized clinical conditions.

DEVICE

ProTaper Rotary System

Root canal instrumentation performed using a multi-file continuous rotary nickel-titanium system according to the manufacturer's protocol. The sequence includes shaping and finishing files (S1, SX, S2, F1, with F2/F3 as required) to achieve canal preparation. The system operates in continuous rotation and is used under standardized clinical conditions.

Sponsors & Collaborators

  • Armed Forces Institute of Dentistry, Pakistan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2026-01-18
Completion
2026-01-29

Countries

  • Pakistan

Study Locations

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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 NCT07510490 on ClinicalTrials.gov