NCT03791762

Incidence of Postoperative Pain After Root Canal Preparation Using Three Different Instruments

Completed NA Last updated 14 July 2020

What this trial tests

NA trial testing WaveOne Gold in Postoperative Pain in 150 participants. Completed in 27 December 2018.

Timeline

1 May 2018

Primary endpoint
25 December 2018

27 December 2018

Quick facts

Lead sponsor	Ondokuz Mayıs University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	150
Start date	1 May 2018
Primary completion	25 December 2018
Estimated completion	27 December 2018
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• WaveOne Gold
• Reciproc Blue
• ProTaper Next

Conditions studied

• Postoperative Pain — all drugs for Postoperative Pain →

Sponsor

Ondokuz Mayıs University

Who can join

Adults 18 to 60, any sex, with Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In an ideal endodontic treatment, maintenance of the original root canal morphology of the canal during root canal preparation, an ideal preparation and obturation is essential. Even if all stages are ideal, pain after endodontic treatment is a clinical condition that may occur after a few hours or several days. Post-operative pain after endodontic treatment is an undesirable condition which makes the clinician and the patient a distressing condition. Many clinical studies reported a 25-40% postoperative pain rate after endodontic treatment, which means that postoperative pain is a clinical symptom that should be considered for endodontist.

The ProTaper Next files (Dentsply Tulsa Dental Specialties) operate in continuous rotary motion, and their center of mass or center of rotation is positioned off-center relative to the instrument's central axis of rotation. During rotation, the files of this design produce a mechanical wave of motion, which travels along the length of the working part of the instrument, minimizing the contact between the file and dentin. According to the manufacturer, the offset design of this instrument also improves debris removal and flexibility in the working part of the file.

New heat treatment has been carried out on NiTi alloy, seeking to increase its flexibility and cyclic fatigue resistance. Recently, the Wave One Gold instrument, manufactured with a new thermal treatment called Gold treatment, was introduced on the market presenting some differences in design, size and taper compared to Wave One. Wave One Gold instrument has a parallelogram cross-sectional design, having two cutting edges, and consists of four instruments, 21/.06 (small), 25/07 (primary), 35/06 (medium) and 45/05 (large) while Wave One presents convex triangular cross-sectional design, besides larger size and taper.

Reciproc blue (REB, VDW), a new-generation reciprocating single-file system, is the latest version of REC. Like the REC file, REB also has an S-shaped cross section, 2 cutting edges, and a noncutting tip. However, REB files are manufactured by altering the molecular structure through a new heat treatment in order to increase the cyclic fatigue resistance. This new heat treatment gives the file its blue color. It was reported that REB files have approximately 2 times higher cyclic fatigue resistance than REC files. In addition, REB files can also be relatively prebent to better access curved canals.

However, the effect of Reciproc Blue, Protaper Next, Waveone Gold within preparation on the postoperative endodontic pain has not been investigated, yet. The aim of this prospective clinical trial was to clinically compare the incidence of postoperative pain after use of different nickel titanium file systems. The purpose of the present study was to evaluate the incidence of postoperative pain root canal preparation performed with Reciproc Blue, Protaper Next, Waveone Gold. The null hypothesis tested was that there is no difference in the incidence and severity of postoperative pain following with any of the 3 instruments.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of postoperative pain after the use of different nickel titanium instrumentation systems: a randomized clinical trial.
   Sivas Yilmaz O, Keskin C, Acar DH, Aydemir H. · · 2022 · cited 2× · PMID 36003844 · DOI 10.26650/eor.2022873271