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

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ClinicalTrials.gov Identifier: NCT03547505
Recruitment Status : Completed
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Cangül Keskin, Ondokuz Mayıs University

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: R-Pilot® Procedure: ProGlider® Procedure: Manual preparation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled clinical trial
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Incidence of Postoperative Pain After Glide Path Preparation Using Manual, Reciprocating and Continuous Rotary Instruments: A Randomized Clinical Trial
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : May 10, 2018

Arm Intervention/treatment
Experimental: R-Pilot®
R-Pilot® was operated by an endomotor (VDW Silver, Munich, Germany) at "Reciproc All" setting.
Procedure: R-Pilot®
Glide path preparation using R-Pilot® in reciprocating manner.
Other Names:
  • Glide path preparation
  • Reciprocating glide path instrument
  • R-Pilot, VDW, Munich, Germany

Experimental: ProGlider®
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®
Glide path preparation using ProGlider® in a rotating manner.
Other Names:
  • Rotating glide path instrument
  • ProGlider, Dentsply Sirona, Ballaigues, Switzerland

Experimental: Manual preparation
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
Glide path preparation using manual K-files numbered from 08 to 15.
Other Names:
  • Glide path creation with stainless steel hand files
  • K-files, Dentsply Sirona, Switzerland




Primary Outcome Measures :
  1. Postoperative Pain Scores using Visual Analogue Scale (VAS) [ Time Frame: 72 hours ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547505


Locations
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Turkey
Ondokuz Mayıs University
Samsun, Turkey, 55400
Sponsors and Collaborators
Ondokuz Mayıs University
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Responsible Party: Cangül Keskin, Principal Investigator, Ondokuz Mayıs University
ClinicalTrials.gov Identifier: NCT03547505    
Other Study ID Numbers: KAEK-357
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cangül Keskin, Ondokuz Mayıs University:
Glide path
postoperative pain
R-Pilot
ProGlider
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Polymethyl Methacrylate
Vasodilator Agents
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs