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

NCT03547505 | Completed

• 1 other identifier: KAEK-357
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

Glide path; postoperative pain; R-Pilot; ProGlider

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Scores using Visual Analogue Scale (VAS)

  VAS is a measure of pain intensity. In the present study, the VAS included a 10 cm straight horizontal line numbered at each centimetre from 0 to 10 showing two extreme symptoms of pain. "0" means no pain and "10" means the worst pain the subject has ever experienced. Each centimeter represents the pain intensity that the subject will mark orientated from 0 to 10. The intensity is increased from 0 to 10, therefore a higher score means a higher pain intensity. There are no subscales.

  72 hours

Study Arms (3)

R-Pilot®

EXPERIMENTAL

R-Pilot® was operated by an endomotor (VDW Silver, Munich, Germany) at "Reciproc All" setting.

Procedure: R-Pilot®

ProGlider®

EXPERIMENTAL

ProGlider® was operated by an endodontic motor (X-Smart, Dentsply Sirona, Ballaigues, Switzerland) with 16:1 contra angle at the suggested settings (300 rpm on display, 5 Ncm).

Procedure: ProGlider®

Manual preparation

EXPERIMENTAL

In the manual glide path group, glide path creation was performed with stainless steel #08, 10, 15 K-files used with "push and pull" motion. Instruments were used with a motion in which the instrument proceeds apically quarterly to the point of resistance, then is pulled out for debris removal. The procedure was repeated with each file until the working length was achieved and confirmed with an electronic apex locator (Root ZX Mini, Morita Corp., Kyoto, Japan).

Procedure: Manual preparation

Interventions

R-Pilot® PROCEDURE

Glide path preparation using R-Pilot® in reciprocating manner.

Also known as: Glide path preparation, Reciprocating glide path instrument, R-Pilot, VDW, Munich, Germany

R-Pilot®

ProGlider® PROCEDURE

Glide path preparation using ProGlider® in a rotating manner.

Also known as: Rotating glide path instrument, ProGlider, Dentsply Sirona, Ballaigues, Switzerland

ProGlider®

Manual preparation PROCEDURE

Glide path preparation using manual K-files numbered from 08 to 15.

Also known as: Glide path creation with stainless steel hand files, K-files, Dentsply Sirona, Switzerland

Manual preparation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with no systemic disease or condition
• Patients having a maxillary or mandibular teeth diagnosed with one of the plural and periodontal diseases (asymptomatic irreversible pulpitis, symptomatic irreversible pulpitis, symptomatic apical periodontitis or asymptomatic apical periodontitis)

You may not qualify if:

• Patients, who were diagnosed with acute or chronic apical abscesses
• Patients showing signs of systemic infection
• Patients with allergies to local anesthetic agents,
• Patients who are taking medication (analgesic, antibiotic or anti-inflammatory drugs) during the 7 days before the procedure
• Patients presenting with multiple teeth requiring treatment or having a progressive periodontal disease

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, 55400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: June 6, 2018
• Study Start: July 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: May 10, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)