Post-operative Pain Following Glide Path Preparation Usin... | NCT04559438

NCT04559438

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rotary Neoniti GPS	Experimental	Glide path preparation using Rotary Neoniti GPS file (Neolix, châtres-la-Forêt, France).	Other: Rotary Neoniti GPS file
Stainless steel K-files	Active Comparator	Glide path preparation using manual stainless steel K-files #10, #15 (Dentsply Maillefer, Ballaigues, Switzerland).	Other: Manual stainless steel K-files

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.
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.
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.
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.
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 Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Heba ElFar, Professor	Cairo University (Endodontics Department)	Study Chair
Dina Morsy, Lecturer	Cairo University (Endodontics Department)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University		Cairo		11331	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22152616	Background	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.
30536837	Background	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.

IPD Sharing Statement Module

Condition Browse Module

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain