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Postoperative Pain After Using Different Single-File Glide Path Systems

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Control
ProGlider
WaveOne Gold Glider
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring chronic apical periodontitis, glide path preparation, Postoperative pain, ProGlider, WaveOne Gold Glider

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Asymptomatic maxillary and mandibular first and second molars diagnosed with chronic apical periodontitis in healthy patients Patients between 18-65 years old Patients who had not taken antidepressants, sedative drugs, analgesics and/or anti-inflammatory drugs Patients who could understand the use of numeric rating scale (NRS) for pain. Exclusion Criteria: Patients who were allergic to anesthetics and non-steroidal drugs Patients who use immunosuppressants Patients who are pregnant or breastfeeding Patients with systemic infections. Teeth with advanced periodontal disease Teeth with acute pain Teeth with calcified or resorbed canals Teeth with complex root canal anatomy Teeth with vital pulp Unrestorable teeth Presence of cracks and/or fractures Teeth associated with acute and chronic apical abscesses

Sites / Locations

  • Eskisehir Osmangazi University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control

ProGlider

WaveOne Gold Glider

Arm Description

Glide path preparation with hand files.

Glide path preparation using rotational NiTi file.

Glide path was preparation using reciprocating NiTi file.

Outcomes

Primary Outcome Measures

Postoperative pain intensity following the use of different glide path preparations
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Postoperative pain intensity following the use of different glide path preparations
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Postoperative pain intensity following the use of different glide path preparations
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Postoperative pain intensity following the use of different glide path preparations
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Postoperative pain intensity following the use of different glide path preparations
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Postoperative pain intensity following the use of different glide path preparations
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.

Secondary Outcome Measures

Full Information

First Posted
July 11, 2023
Last Updated
July 19, 2023
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05955742
Brief Title
Postoperative Pain After Using Different Single-File Glide Path Systems
Official Title
Evaluation of Postoperative Pain After Using Different Single-File Glide Path Systems: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aimed to evaluate postoperative pain intensity after glide-path preparation with the ProGlider (PG) and WaveOne Gold Glider (WOGG) systems in asymptomatic teeth with necrotic pulp and periapical lesions.Maxillary and mandibular molars with chronic apical periodontitis of 78 patients (age, 18-65 years) were included. The patients were randomly divided into three groups: control (n = 26), PG (n = 26), and WOGG (n = 26). All systems were used according to the manufacturer's instructions, and all root canal treatments were completed by a single operator within two sessions. Postoperative pain was assessed using a numerical rating scale (NRS) at 6, 12, 18, 24, 48, and 72 h. The intake of prescribed analgesics and abscess formation were also recorded.
Detailed Description
Pain after root canal treatment is an important complication encountered in endodontic practice, with a reported prevalence of 3%-58%. Severe pain may start even 24 to 48 h after treatment. Postoperative pain has a complex etiology, including treatment factors under the control of the clinician, microbial factors related to the contents of infected root canals, patient demographic factors (patient sex and age, among others), immunological factors, local tissue changes, and psychological factors. Debris extrusion to the periapical tissues during root canal instrumentation can significantly influence the incidence and intensity of postoperative pain. The root canal instrumentation technique may play an important role in the occurrence of postoperative pain as it can induce an acute inflammatory response following periapical extrusion of necrotic tissues, infected debris, and bacteria. Previous clinical trials have evaluated the effect of reciprocation and continuous rotation kinematics on debris extrusion and postoperative pain; however, their results are conflicting. The glide path is defined as a straight tunnel extending from the canal orifice to the physiological apical foramen. Glide-path preparation may prevent complications of root canal instrumentation; reduce risk of instrument failure, debris extrusion, and postoperative pain; and preserve root canal anatomy, thereby reducing the risk of transportation, perforation, and step and zip formation. Many NiTi glide-path file systems of different sizes and metallurgical properties have been introduced to date. Recently, a new single glide-path file system was introduced with the aim of reducing the number of files used and simplifying glide-path instrumentation. The effect of glide-path file systems on postoperative pain has been studied previously. However, to the best of investigators' knowledge, there are no data comparing PG and WOGG glide-path files in terms of postoperative pain in asymptomatic teeth with necrotic pulp and periapical lesions. Therefore, the purpose of this in vivo study was to evaluate the incidence and intensity of postoperative pain in asymptomatic maxillary and mandibular molars with necrotic pulp and periapical lesions after glide-path preparation with a stainless-steel K-file and PG and WOGG glide-path file systems. The null hypothesis was that there is no difference in the incidence and intensity of postoperative pain between glide-path preparation techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
chronic apical periodontitis, glide path preparation, Postoperative pain, ProGlider, WaveOne Gold Glider

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: control Group 2: ProGlider Group 3: WaveOne Gold Glider
Masking
ParticipantOutcomes Assessor
Masking Description
The patient and statistician were blind to the groups but the operator who performed all treatment procedures could not be blinded to the study group owing to the study design.
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
Glide path preparation with hand files.
Arm Title
ProGlider
Arm Type
Experimental
Arm Description
Glide path preparation using rotational NiTi file.
Arm Title
WaveOne Gold Glider
Arm Type
Experimental
Arm Description
Glide path was preparation using reciprocating NiTi file.
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
The operator prepared the glide path using a #15K-type stainless-steel hand file.
Intervention Type
Device
Intervention Name(s)
ProGlider
Intervention Description
The operator prepared the glide path using the ProGlider file.
Intervention Type
Device
Intervention Name(s)
WaveOne Gold Glider
Intervention Description
The operator prepared the glide path using the WaveOne Gold Glider file.
Primary Outcome Measure Information:
Title
Postoperative pain intensity following the use of different glide path preparations
Description
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Time Frame
6th hour
Title
Postoperative pain intensity following the use of different glide path preparations
Description
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Time Frame
12th hour
Title
Postoperative pain intensity following the use of different glide path preparations
Description
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Time Frame
18th hour
Title
Postoperative pain intensity following the use of different glide path preparations
Description
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Time Frame
24th hour
Title
Postoperative pain intensity following the use of different glide path preparations
Description
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Time Frame
48th hour
Title
Postoperative pain intensity following the use of different glide path preparations
Description
Postoperative pain was assessed using a numerical rating scale (NRS), The severity of pain varies between 0 to 10, in which 0 means no pain, while 10 means unbearable pain.
Time Frame
72nd hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Asymptomatic maxillary and mandibular first and second molars diagnosed with chronic apical periodontitis in healthy patients Patients between 18-65 years old Patients who had not taken antidepressants, sedative drugs, analgesics and/or anti-inflammatory drugs Patients who could understand the use of numeric rating scale (NRS) for pain. Exclusion Criteria: Patients who were allergic to anesthetics and non-steroidal drugs Patients who use immunosuppressants Patients who are pregnant or breastfeeding Patients with systemic infections. Teeth with advanced periodontal disease Teeth with acute pain Teeth with calcified or resorbed canals Teeth with complex root canal anatomy Teeth with vital pulp Unrestorable teeth Presence of cracks and/or fractures Teeth associated with acute and chronic apical abscesses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kubra Yesildal Yeter, Assoc. Prof.
Organizational Affiliation
Eskisehir Osmangazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskisehir Osmangazi University
City
Eskişehir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Postoperative Pain After Using Different Single-File Glide Path Systems

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