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NCT Number: NCT07133217

Comparative Evaluation of Postoperative Pain and Clinical Success

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.

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Key information

Conditions

Symptomatic Irreversible Pulpitis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gözde Kandemir Demirci

Izmir, 35100, Turkey (Türkiye)

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Root canal preparation with Hand Files (Dentsply Sirona)

Device

Root canal treatments were performed with hand files

Root canal preparation with the WaveOne Gold file system (Dentsply Sirona, Ballaigues, Switzerland)

Device

Root canal treatments were performed with WaveOne Gold Files

Root canal preparation with the ProTaper Ultimate file system (Dentsply Sirona)

Device

Root canal treatments were performed with ProTaper Ultimate Files

Primary outcomes

  1. The incidence and intensity of post-obturation pain

    Time frame: up to 30-day

    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.

Secondary outcomes

  1. Clinical and radiographical success

    Time frame: Up to 1 year follow up

    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).

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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