MedTrace Logo

Comparative Evaluation of Postoperative Pain and Clinical Success

NCT07133217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-08-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Ege University

    lead OTHER

Principal Investigators

  • Gözde Kandemir Demirci, Associate Professor · Ege University Faculty of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-11
Primary Completion
2025-07-11
Completion
2025-07-11

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07133217 on ClinicalTrials.gov