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NCT07133217
Comparative Evaluation of Postoperative Pain and Clinical Success
NA trial testing Root canal preparation with Hand Files (Dentsply Sirona) in Symptomatic Irreversible Pulpitis in 63 participants. Completed in 11 July 2025.
11 July 2025
Quick facts
| Lead sponsor | Ege University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 63 |
| Start date | 11 June 2024 |
| Primary completion | 11 July 2025 |
| Estimated completion | 11 July 2025 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Root canal preparation with Hand Files (Dentsply Sirona)
- Root canal preparation with the WaveOne Gold file system (Dentsply Sirona, Ballaigues, Switzerland)
- Root canal preparation with the ProTaper Ultimate file system (Dentsply Sirona)
Conditions studied
- Symptomatic Irreversible Pulpitis — all drugs for Symptomatic Irreversible Pulpitis →
Sponsor
Ege University
Who can join
Adults 18 to 65, any sex, with Symptomatic Irreversible Pulpitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07133217
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
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Other Ege University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07133217 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ege University
- Last refreshed: 20 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07133217.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing