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Post-operative Pain Following Glide Path Preparation Using Rotary Neoniti GPS File and Manual K-files

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Rotary Neoniti GPS file
Manual stainless steel K-files
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Systemically healthy patients (ASA I or II)
  2. Lower permanent molar teeth with:

Asymptomatic non-vital pulps, No response of pulp tissue to cold pulp tester (ethyl chloride spray), with or without periapical lesions.

Exclusion Criteria:

  1. Medically compromised patients having significant systemic disorders. (ASA III or IV).
  2. History of intolerance to NSAIDS.
  3. Patients with two or more adjacent teeth requiring endodontic treatment.
  4. TMJ problems, bruxism, clenching or traumatic occlusion.
  5. Inability to perceive the given instructions.
  6. Teeth with:

Vital pulp tissues. Association with swelling. Acute periapical abscess. Mobility Grade II or III. Pocket depth more than 5mm. Previous root canal therapy. Non-restorability.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rotary Neoniti GPS

Stainless steel K-files

Arm Description

Glide path preparation using Rotary Neoniti GPS file (Neolix, châtres-la-Forêt, France).

Glide path preparation using manual stainless steel K-files #10, #15 (Dentsply Maillefer, Ballaigues, Switzerland).

Outcomes

Primary Outcome Measures

Postoperative pain assessed using the Visual Analogue Scale
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Postoperative pain assessed using the Visual Analogue Scale
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Postoperative pain assessed using the Visual Analogue Scale
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Postoperative pain assessed using the Visual Analogue Scale
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Postoperative pain assessed using the Visual Analogue Scale
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.

Secondary Outcome Measures

Number of analgesic tablets taken by the patient
Number of analgesic tablets taken by the patient after root canal treatment.

Full Information

First Posted
September 10, 2020
Last Updated
February 2, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04559438
Brief Title
Post-operative Pain Following Glide Path Preparation Using Rotary Neoniti GPS File and Manual K-files
Official Title
Post-operative Pain Following Glide Path Preparation Using Rotary Neoniti GPS File and Manual K-files in Non-vital Lower Molars: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
The aim of this study is to clinically compare the incidence of post-operative pain after using rotary glide path file (Neoniti GPS), on post-operative pain when compared to manual glide path preparation in lower molars with asymptomatic non-vital pulp.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotary Neoniti GPS
Arm Type
Experimental
Arm Description
Glide path preparation using Rotary Neoniti GPS file (Neolix, châtres-la-Forêt, France).
Arm Title
Stainless steel K-files
Arm Type
Active Comparator
Arm Description
Glide path preparation using manual stainless steel K-files #10, #15 (Dentsply Maillefer, Ballaigues, Switzerland).
Intervention Type
Other
Intervention Name(s)
Rotary Neoniti GPS file
Intervention Description
Glide path creation will be achieved using Neoniti GPS file (15/.03). The file will be introduced passively inside the canal, in continuous rotation at a constant speed between 300 and 500 rpm and torque of 1.5 N.
Intervention Type
Other
Intervention Name(s)
Manual stainless steel K-files
Intervention Description
Glide path preparation will be done by hand instrumentation using K-files #10 and 15.
Primary Outcome Measure Information:
Title
Postoperative pain assessed using the Visual Analogue Scale
Description
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Time Frame
6 hours post treatment.
Title
Postoperative pain assessed using the Visual Analogue Scale
Description
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Time Frame
12 hours post-treatment.
Title
Postoperative pain assessed using the Visual Analogue Scale
Description
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Time Frame
24 hours post-treatment.
Title
Postoperative pain assessed using the Visual Analogue Scale
Description
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Time Frame
48 hours post-treatment.
Title
Postoperative pain assessed using the Visual Analogue Scale
Description
Intensity of pain after root canal treatment will be recorded by the patient where; "0" = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Time Frame
72 hours post treatment.
Secondary Outcome Measure Information:
Title
Number of analgesic tablets taken by the patient
Description
Number of analgesic tablets taken by the patient after root canal treatment.
Time Frame
Up to 72 hours post treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Systemically healthy patients (ASA I or II) Lower permanent molar teeth with: Asymptomatic non-vital pulps, No response of pulp tissue to cold pulp tester (ethyl chloride spray), with or without periapical lesions. Exclusion Criteria: Medically compromised patients having significant systemic disorders. (ASA III or IV). History of intolerance to NSAIDS. Patients with two or more adjacent teeth requiring endodontic treatment. TMJ problems, bruxism, clenching or traumatic occlusion. Inability to perceive the given instructions. Teeth with: Vital pulp tissues. Association with swelling. Acute periapical abscess. Mobility Grade II or III. Pocket depth more than 5mm. Previous root canal therapy. Non-restorability.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba ElFar, Professor
Organizational Affiliation
Cairo University (Endodontics Department)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dina Morsy, Lecturer
Organizational Affiliation
Cairo University (Endodontics Department)
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11331
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22152616
Citation
Pasqualini D, Mollo L, Scotti N, Cantatore G, Castellucci A, Migliaretti G, Berutti E. Postoperative pain after manual and mechanical glide path: a randomized clinical trial. J Endod. 2012 Jan;38(1):32-6. doi: 10.1016/j.joen.2011.09.017. Epub 2011 Oct 27. Erratum In: J Endod. 2012 Mar;38(3):356.
Results Reference
background
PubMed Identifier
30536837
Citation
Keskin C, Sivas Yilmaz O, Inan U, Ozdemir O. Postoperative pain after glide path preparation using manual, reciprocating and continuous rotary instruments: a randomized clinical trial. Int Endod J. 2019 May;52(5):579-587. doi: 10.1111/iej.13053. Epub 2018 Dec 31.
Results Reference
background
PubMed Identifier
20973422
Citation
West JD. The endodontic Glidepath: "Secret to rotary safety". Dent Today. 2010 Sep;29(9):86, 88, 90-3.
Results Reference
background

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Post-operative Pain Following Glide Path Preparation Using Rotary Neoniti GPS File and Manual K-files

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