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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04559438
• Other study ID #: ENDO 3-3-5
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• Rotary 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.
• Manual stainless steel K-files
Glide path preparation will be done by hand instrumentation using K-files #10 and 15.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. Erratum In: J Endod. 2012 Mar;38(3):356. — View Citation

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

Outcome

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