Clinical trial NCT04559438: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative pain assessed using the Visual Analogue Scale
timeFrame: 6 hours post treatment.
measure: Postoperative pain assessed using the Visual Analogue Scale
timeFrame: 12 hours post-treatment.
measure: Postoperative pain assessed using the Visual Analogue Scale
timeFrame: 24 hours post-treatment.
measure: Postoperative pain assessed using the Visual Analogue Scale
timeFrame: 48 hours post-treatment.
measure: Postoperative pain assessed using the Visual Analogue Scale
timeFrame: 72 hours post treatment.
Secondary outcomes:
measure: Number of analgesic tablets taken by the patient
timeFrame: Up to 72 hours post treatment.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University (Endodontics Department)
name: Heba ElFar, Professor
role: STUDY_CHAIR
affiliation: Cairo University (Endodontics Department)
name: Dina Morsy, Lecturer
role: STUDY_DIRECTOR
References:
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.
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.
citation: West JD. The endodontic Glidepath: "Secret to rotary safety". Dent Today. 2010 Sep;29(9):86, 88, 90-3.