NCT03547505

Incidence of Postoperative Pain After Glide Path Preparation Using Three Different Instruments

Completed NA Last updated 6 June 2018

What this trial tests

NA trial testing R-Pilot® in Postoperative Pain in 240 participants. Completed in 10 May 2018.

Timeline

1 July 2017

Primary endpoint
30 April 2018

10 May 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	240
Start date	1 July 2017
Primary completion	30 April 2018
Estimated completion	10 May 2018
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• R-Pilot®
• ProGlider®
• Manual preparation

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

Endodontic postoperative pain is described as a sensation of discomfort following the completion of root canal treatment and is experienced by the 25-40% of the patients regardless of pulp and periradicular diseases (1, 2). Prevalence of pain has been reported to decrease from 40% in the first 48 hours to 11% after 7 days (2). Mechanisms of endodontic postoperative pain is multifactorial and procedural processes such as glide path preparation, establishment of apical patency or root canal instrumentation technique were claimed to influence the posttreatment pain incidence (3-5).

Glide path preparation has been reported to guide the successor instruments and prevent complications of root canal preparation such as taper lock, instrument separation, transportation, and ledge formation (6-8). Several instruments and techniques have been suggested for the preparation of glide path, including hand preparation with stainless steel K-files, the combination of reciprocating handpiece and stainless steel K-files or the use of a less tapered motor-driven nickel-titanium (NiTi) rotary instrument (9-11). The use of NiTi rotary instruments has been associated with a less time-consuming and safe glide path preparation, which respects to the original canal anatomy (9, 10).

The ProGlider (Dentsply Sirona; Ballaigues, Switzerland) is a rotary glide path instrument manufactured from memory NiTi wire, which provides increased fatigue resistance, compared to the conventional NiTi glide path instruments (12). The concept of reciprocation motion was introduced with the expectation of a safer instrumentation with a single file (13). Reciprocation motion has been reported to increase the fatigue resistance of the instrument by exerting to lower stress values compared to the continuous rotation (14). The R-Pilot (VDW; Munich, Germany) instrument introduces the reciprocating motion to the glide path preparation (15). Reciprocating motion has been reported to produce greater amount of apically extruded debris, which was associated with irritation of periradicular tissues and postoperative endodontic pain, compared to continuous motion (16). However, a few clinical trials compared the reciprocation and rotation kinematics regarding their effect on postoperative pain and reported conflicting results, which could be attributed to the use of different instrumentation systems with different mechanical properties and designs (17-19). However, the effect of reciprocating motion during glide path preparation on the postoperative endodontic pain has not been investigated, yet. The purpose of the present study was to evaluate the incidence of postoperative pain after glide path preparation performed with stainless steel K-files, ProGlider or R-Pilot glide path instruments. The null hypothesis tested was that there is no difference in the incidence and severity of postoperative pain following the glide path preparation with any of the 3 instruments.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.