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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04559438

Enrollment

Registered

2020-09-22

Start date

2021-01-01

Completion date

2022-04-01

Last updated

2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

OTHERRotary Neoniti GPS file

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.

OTHERManual stainless steel K-files

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain assessed using the Visual Analogue Scale	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.

Secondary

Measure	Time frame	Description
Number of analgesic tablets taken by the patient	Up to 72 hours post treatment.	Number of analgesic tablets taken by the patient after root canal treatment.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026