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

• Sponsor: Cairo University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04559438
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.9
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Other: Rotary Neoniti GPS file; Other: Manual stainless steel K-files	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rotary Neoniti GPS Glide path preparation using Rotary Neniti GPS file (Neolix, châtres-la-Forêt, France).	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.
Active Comparator: Stainless steel K-files Glide path preparation using manual stainless steel K-files #10, #15 (Dentsply Maillefer, Ballaigues, Switzerland).	Other: Manual stainless steel K-files; Glide path preparation will be done by hand instrumentation using K-files #10 and 15.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Postoperative pain assessed using the Visual Analogue Scale [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 [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 [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 [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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt	11331

Sponsors and Collaborators

• Cairo University

Investigators

• Study Chair: Heba ElFar, Professor, Cairo University (Endodontics Department)
• Study Director: Dina Morsy, Lecturer, Cairo University (Endodontics Department)

Study Documents (Full-Text)

None provided.

More Information

Publications

• Keskin C, Sivas Yilmaz Ö, Inan U, Özdemir Ö. 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.
• 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.
• West JD. The endodontic Glidepath: "Secret to rotary safety". Dent Today. 2010 Sep;29(9):86, 88, 90-3.

• Responsible Party: Engy Abdel Nour Atallah, Principal investigator, Resident at faculty of dentistry, Cairo University., Cairo University
• ClinicalTrials.gov Identifier: NCT04559438
• Other Study ID Numbers: ENDO 3-3-5
• First Posted: Sep 22, 2020
• Last Update Posted: Dec 29, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Dec 29, 2021