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Completed

NCT Number: NCT04559438

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

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 11331, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Manual stainless steel K-files

Other

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

Primary outcomes

  1. Postoperative pain assessed using the Visual Analogue Scale

    Time frame: 6 hours post treatment.

    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.

  2. Postoperative pain assessed using the Visual Analogue Scale

    Time frame: 12 hours post-treatment.

    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.

  3. Postoperative pain assessed using the Visual Analogue Scale

    Time frame: 24 hours post-treatment.

    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.

  4. Postoperative pain assessed using the Visual Analogue Scale

    Time frame: 48 hours post-treatment.

    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.

  5. Postoperative pain assessed using the Visual Analogue Scale

    Time frame: 72 hours post treatment.

    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 outcomes

  1. Number of analgesic tablets taken by the patient

    Time frame: Up to 72 hours post treatment.

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 22, 2020
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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