Comparative Evaluation of Postoperative Pain and Clinical Success

Comparative Evaluation of Postoperative Pain and Clinical Success Following Root Canal Treatment With Hand Files, ProTaper Ultimate, and WaveOne Gold Systems in Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial

Sixty-three mandibular molars with vital pulp, symptomatic acute pain, and a Numerical Rating Scale (NRS) score of 7 or higher-requiring emergency treatment-were randomly allocated into three groups according to the preparation systems to be used: conventional manual instrumentation technique with hand files, reciprocating motion technique with WaveOne Gold files, and rotary motion technique with ProTaper Ultimate files.

In the first session, patients received emergency treatment with one of the three file systems, and seven days later, root canal treatments were completed using the same system within each patient group. Preoperative pain scores of patients presenting to our clinic with acute pain were recorded using the Numerical Rating Scale (NRS).

During the emergency root canal treatment session, the first group was instrumented with hand files, the second group with WaveOne Gold files, and the third group with ProTaper Ultimate files, and the emergency treatment session was completed. Shaping times were measured during the procedures.

Following the emergency session, patients were instructed to record their postoperative pain at the 6th hour, 12th hour, and on the 1st, 2nd, 3rd, 4th, 5th, 6th, and 7th days using the provided NRS.

One week after the emergency treatment session, root canal obturation was performed using each system's own gutta-percha and Bioceramic root canal sealer. Clinical and radiographic follow-ups were carried out at 6 and 12 months.

Study Overview

• Status: Completed
• Conditions: Symptomatic Irreversible Pulpitis
• Intervention / Treatment: Device: Root canal preparation with Hand Files (Dentsply Sirona); Device: Root canal preparation with the WaveOne Gold file system (Dentsply Sirona, Ballaigues, Switzerland); Device: Root canal preparation with the ProTaper Ultimate file system (Dentsply Sirona)

Detailed Description

• This randomized clinical study was conducted to evaluate and compare the effects of the conventional step-back technique with hand files, the reciprocal technique with WaveOne Gold files, and the rotary technique with ProTaper Ultimate files on the frequency and intensity of pain before and after emergency treatment, as well as on clinical and radiological outcomes in symptomatic and acutely painful vital molars during root canal treatment.

Sixty-three symptomatic mandibular molars with vital pulp were randomly allocated into three groups according to the preparation system used: Hand files, WaveOne Gold, and ProTaper Ultimate. The file systems assigned to each group were used for root canal preparation in all cases.

In the rotary and reciprocating file groups, obturation was performed with their own gutta-percha using the single cone technique with Bioceramic sealer and in the conventional hand file group root canal obturation was performed with cold lateral compaction method.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35100
    • Gözde Kandemir Demirci

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients aged 18-65
• Patients who can come to regular check-ups and have high treatment motivation
• Patients who can establish an appropriate patient-doctor dialogue
• Patients without systemic disease
• Patients with teeth that have not previously undergone endodontic treatment
• Patients who meet the clinical definition of symptomatic irreversible pulpitis (pain, prolonged sensitivity to hot and cold,percussion sensitivity, pulpal bleeding)
• Delayed positive response of teeth to cold testing and electric pulp testing
• Presence of spontaneous pain before treatment
• Mandibular first or second molar with complete root development
• Formation of large pulpal perforation during caries removing
• Presence of bleeding in the exposed pulp that cannot be stopped within 5 minutes after the pulp exposure

Exclusion Criteria:

• Patients who refused to participate in the study
• Patients at medical risk (patients with immune system diseases/systemic diseases, patients using medication),
• Patients with NSAID (non-steroidal anti-inflammatory) allergy
• Patients with allergy to the materials used during root canal treatment
• Patients who used antibiotics or analgesics before applying to the clinic
• Pregnant patients
• Asymptomatic or devital teeth
• Presence of advanced periodontal disease (probing depth> 3 mm)
• Patients with more than one tooth requiring endodontic treatment
• The relevant tooth has previously undergone endodontic treatment
• The tooth needs a post-core or is a prosthetic support tooth
• Presence of calcified root canal
• Teeth with internal or external root resorption
• Teeth with open apex
• Mandibular third molars

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Manuel Instrumentation Technique Group; Root canals were prepared with hand files. Irrigation was performed with 10 mL of NaOCl, followed by 5 mL of 17% ethylenediaminetetraacetic acid (EDTA). Temporary coronal restoration was completed with glass ionomer cement. For this group, 72 hours after the completion of root canal preparation in the emergency intervention session, calcium hydroxide was applied to the root canals for 7 days, and the teeth were obturated using a bioceramic root canal sealer with the system-specific gutta-percha and obturation methods recommended by the manufacturers.	Device: Root canal preparation with Hand Files (Dentsply Sirona); Root canal treatments were performed with hand files
Active Comparator: Reciprocating Motion Technique Group; Root canals were prepared with WaveOne Gold instruments and an X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Irrigation was performed with 10 mL of NaOCl, followed by 5 mL of 17% ethylenediaminetetraacetic acid (EDTA). Temporary coronal restoration was completed with glass ionomer cement. For this group, 72 hours after the completion of root canal preparation in the emergency intervention session, calcium hydroxide was applied to the root canals for 7 days, and the teeth were obturated using a bioceramic root canal sealer with the system-specific gutta-percha and obturation methods recommended by the manufacturers.	Device: Root canal preparation with the WaveOne Gold file system (Dentsply Sirona, Ballaigues, Switzerland); Root canal treatments were performed with WaveOne Gold Files
Active Comparator: Rotation Motion Technique Group; Root canals were prepared with ProTaper Ultimate instruments and an X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Irrigation was performed with 10 mL of NaOCl, followed by 5 mL of 17% ethylenediaminetetraacetic acid (EDTA). Temporary coronal restoration was completed with glass ionomer cement. For this group, 72 hours after the completion of root canal preparation in the emergency intervention session, calcium hydroxide was applied to the root canals for 7 days, and the teeth were obturated using a bioceramic root canal sealer with the system-specific gutta-percha and obturation methods recommended by the manufacturers.	Device: Root canal preparation with the ProTaper Ultimate file system (Dentsply Sirona); Root canal treatments were performed with ProTaper Ultimate Files

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence and intensity of post-obturation pain	Post-obturation pain up to 30 days after root canal treatment was measured with Numerical Rating Scale. The Numerical Rating Scale is a pain measurement scale that encompasses the following grades: 0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain.	up to 30-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and radiographical success	Clinical success was determined by the absence of any clinical or radiographic indicators of inflammation or infection, and outcomes were categorized as either successful or unsuccessful.Unsuccessful ones were scored as "0" and successful ones as "1". During the clinical examination, the presence of swelling, pain, sinus tract formation, or tenderness upon percussion or palpation was documented. Periodontal probing depths were assessed for each case. Radiographic analysis evaluated the integrity of periodontal tissues and the presence or absence of periapical radiolucent areas. The level of root canal fillings was classified as short (≥2 mm from the apex), acceptable (0-2 mm), or overfilled (beyond apex).	Up to 1 year follow up

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Principal Investigator: Gözde Kandemir Demirci, Associate Professor, Ege University Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Actual): July 11, 2025
• Study Completion (Actual): July 11, 2025

Study Registration Dates

• First Submitted: August 12, 2025
• First Submitted That Met QC Criteria: August 19, 2025
• First Posted (Actual): August 20, 2025

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative pain; Emergency treatment; Symptomatic irreversible pulpitis; Bioceramic sealer; Clinical success; Hand file; Reciprocating file; Rotary file
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Dental Pulp Diseases; Tooth Diseases; Pain, Postoperative; Pulpitis; Physiological Effects of Drugs; Protective Agents; Vasodilator Agents; Antimutagenic Agents; Polymethyl Methacrylate
• Other Study ID Numbers: 23-9.1/4; TS-GAP-2024-32255 (Other Grant/Funding Number: Ege University Scientific Research Projects)

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
• product manufactured in and exported from the U.S.: No