Comparative Evaluation of Postoperative Pain and Clinical Success

NCT07133217 | Completed DMC

• 2 other identifiers: 23-9.1/4TS-GAP-2024-32255
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Symptomatic Irreversible Pulpitis

Keywords

Bioceramic sealer; Clinical success; Emergency treatment; Hand file; Postoperative pain; Reciprocating file; Rotary file; Symptomatic irreversible pulpitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical and radiographical success

  Up to 1 year follow up

Study Arms (3)

Conventional Manuel Instrumentation Technique Group

ACTIVE COMPARATOR

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)

Reciprocating Motion Technique Group

ACTIVE COMPARATOR

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)

Rotation Motion Technique Group

ACTIVE COMPARATOR

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)

Interventions

Root canal preparation with Hand Files (Dentsply Sirona) DEVICE

Root canal treatments were performed with hand files

Conventional Manuel Instrumentation Technique Group

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

Root canal treatments were performed with WaveOne Gold Files

Reciprocating Motion Technique Group

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

Root canal treatments were performed with ProTaper Ultimate Files

Rotation Motion Technique Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Gözde Kandemir Demirci

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Root Canal Preparation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Root Canal Therapy; Endodontics; Dentistry; Tooth Preparation

Study Officials

• Gözde Kandemir Demirci, Associate Professor

  Ege University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 20, 2025
• Study Start: June 11, 2024
• Primary Completion: July 11, 2025
• Study Completion: July 11, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)