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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Other: Rotary Neoniti GPS file; Other: Manual stainless steel K-files

• Registration Number: NCT04559438
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-22
• Study Start: 2021-01-01
• Primary Completion: 2021-10-01
• Study Completion: 2022-04-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotary Neoniti GPS	Rotary Neoniti GPS file	Glide path preparation using Rotary Neoniti GPS file (Neolix, châtres-la-Forêt, France).
Stainless steel K-files	Manual stainless steel K-files	Glide path preparation using manual stainless steel K-files #10, #15 (Dentsply Maillefer, Ballaigues, Switzerland).

Primary Outcome Measures

Name	Time	Method
Postoperative pain assessed using the Visual Analogue Scale	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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt