NCT07133217

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Ege University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Symptomatic Irreversible Pulpitis

Interventions

Type	Name	Description
DEVICE	Root canal preparation with Hand Files (Dentsply Sirona)	Root canal treatments were performed with hand files
DEVICE	Root canal preparation with the WaveOne Gold file system (Dentsply Sirona, Ballaigues, Switzerland)	Root canal treatments were performed with WaveOne Gold Files
DEVICE	Root canal preparation with the ProTaper Ultimate file system (Dentsply Sirona)	Root canal treatments were performed with ProTaper Ultimate Files

Timeline

• Start date: 2024-06-11
• Primary completion: 2025-07-11
• Completion: 2025-07-11
• First posted: 2025-08-20
• Last updated: 2025-08-20

Locations

1 site across 1 country: Turkey (Türkiye)