Comparison of WaveOne and ProTaper Systems on Postoperative Pain in Irreversible Pulpitis Patients (WOPP-IP)

March 30, 2026 updated by: Ahmed Abdullah, Armed Forces Institute of Dentistry, Pakistan

Comparison Between Root Canal Preparation Using WaveOne Reciprocating and ProTaper Rotary Instruments on Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Root canal treatment is a commonly performed dental procedure aimed at eliminating inflamed or infected pulp tissue and preventing further periapical complications. Despite advancements in endodontic techniques, postoperative pain remains a frequent concern, particularly in patients with symptomatic irreversible pulpitis.

Mechanical preparation of the root canal system plays a critical role in treatment success. Nickel-titanium (NiTi) instruments are widely used for this purpose and are available in different kinematic systems, including reciprocating single-file systems (such as WaveOne) and continuous rotary multi-file systems (such as ProTaper). These systems differ in their motion, number of files used, and potential for apical extrusion of debris, which may influence postoperative pain.

Previous studies comparing reciprocating and rotary systems have reported inconsistent results regarding postoperative pain outcomes. Some evidence suggests that rotary systems may be associated with reduced early postoperative pain, possibly due to more controlled instrumentation and reduced debris extrusion. However, other studies have found no significant difference between the two systems.

This randomized controlled trial is designed to compare postoperative pain following root canal treatment using WaveOne and ProTaper systems in patients with symptomatic irreversible pulpitis. A total of 146 patients will be randomly allocated into two groups. All treatments will be performed in two visits under standardized clinical conditions by a single operator to minimize variability.

Local anesthesia will be administered, and working length will be determined using an ultrasonic apex locator and radiographic verification. Instrumentation will be performed according to manufacturer guidelines for each system. Irrigation protocols and temporary restoration procedures will be standardized across both groups.

Postoperative pain will be assessed using the Numerical Rating Scale (NRS). Patients will record their pain intensity at multiple time intervals after the procedure. Analgesic intake will also be documented. At the second visit, obturation will be completed using standard techniques.

The primary outcome of this study is the intensity of postoperative pain at different time intervals. Secondary outcomes include the duration of pain and the need for analgesic medication. Statistical analysis will be performed to compare outcomes between the two groups.

The results of this study are expected to provide clinically relevant evidence regarding the effect of instrumentation technique on postoperative pain and may assist clinicians in making evidence-based decisions to improve patient outcomes.

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan, 44000
        • Armed Forces Institute of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients aged 18-60 years Patients diagnosed with symptomatic irreversible pulpitis Patients requiring root canal treatment in permanent teeth Teeth with canal curvature ≤25° (assessed using Schneider's method) Patients willing to provide informed consent

Exclusion Criteria:

Patients with systemic illness Pregnant patients Patients with hypersensitivity to nonsteroidal anti-inflammatory drugs Teeth with apical pathology or periapical lesions Teeth with root resorption or internal ankylosis History of dental trauma in the affected tooth Teeth with malposition or severe malocclusion Patients with periodontal disease (periodontal index <3) Patients with trismus or sinus tract Patients with severe anxiety affecting dental procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WaveOne Reciprocating Instrumentation
Participants in this arm will undergo root canal treatment using the WaveOne reciprocating single-file system according to the manufacturer's protocol. Instrumentation will be performed under standardized clinical conditions, and postoperative pain will be assessed using the Numerical Rating Scale (NRS) at predefined time intervals.
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.
Other Names:
  • WaveOne Files
Active Comparator: ProTaper Rotary Instrumentation
Participants in this arm will undergo root canal treatment using the ProTaper rotary multi-file system according to the manufacturer's protocol. Treatment will be performed under standardized clinical conditions, and postoperative pain will be recorded using the Numerical Rating Scale (NRS) at specified time intervals.
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.
Other Names:
  • ProTaper Universal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of Postoperative Pain Following Root Canal Instrumentation
Time Frame: 6, 12, 24, 48, and 72 hours after instrumentation, and at 1 week
Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst possible pain. Patients will record their pain scores at specified time intervals after root canal instrumentation. Median pain scores will be compared between the two groups.
6, 12, 24, 48, and 72 hours after instrumentation, and at 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Forces Institute of Dentistry, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2025

Primary Completion (Actual)

January 18, 2026

Study Completion (Actual)

January 29, 2026

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFID2
  • AFID-2025-RCT-02 (Other Identifier: Institutional Study ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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