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
About this trial
This is an interventional treatment trial for Postoperative Pain
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.
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
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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