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

NCT04559438 | Completed

• 1 other identifier: ENDO 3-3-5
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (5)

• 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.

  6 hours post treatment.

• 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.

  12 hours post-treatment.

• 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.

  24 hours post-treatment.

• 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.

  48 hours post-treatment.

• 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.

  72 hours post treatment.

Secondary Outcomes (1)

• Number of analgesic tablets taken by the patient

  Up to 72 hours post treatment.

Study Arms (2)

Rotary Neoniti GPS

EXPERIMENTAL

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

Other: Rotary Neoniti GPS file

Stainless steel K-files

ACTIVE COMPARATOR

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

Other: Manual stainless steel K-files

Interventions

Rotary Neoniti GPS file OTHER

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.

Rotary Neoniti GPS

Manual stainless steel K-files OTHER

Glide path preparation will be done by hand instrumentation using K-files #10 and 15.

Stainless steel K-files

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11331, Egypt

Location

Related Publications (3)

• 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.

  PMID: 22152616 BACKGROUND

• 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.

  PMID: 30536837 BACKGROUND

• West JD. The endodontic Glidepath: "Secret to rotary safety". Dent Today. 2010 Sep;29(9):86, 88, 90-3.

  PMID: 20973422 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Heba ElFar, Professor

  Cairo University (Endodontics Department)

  STUDY CHAIR

• Dina Morsy, Lecturer

  Cairo University (Endodontics Department)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Resident at faculty of dentistry, Cairo University.

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 22, 2020
• Study Start: January 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: April 1, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Locations

EG (1)