Post-instrumentation Pain After Use of the Fanta and M3 Pro Gold Systems

Post-instrumentation Pain After Use of the Fanta and M3 Pro Gold Systems: A Randomized Clinical Trial

Comparing the intensity of post-operative pain following endodontic treatment of posterior teeth with Fanta (Pepsi gold) (FPG) and M3-pro+ Gold (assorted) (MPG) rotary files.

Study Overview

• Status: Completed
• Conditions: Endodontic Treatment
• Intervention / Treatment: Procedure: Fanta (Pepsi gold) (FPG); Procedure: M3-pro+ Gold (assorted) (MPG)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12573
    • Faculty of Oral and Dental medicine, Ahram Canadian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 20-50 years old
• No systemic diseases
• Mandibular first molar
• Asymptomatic tooth
• Normal periapical film
• Restorable teeth
• Periodontal scoring index <2

Exclusion Criteria:

• Age <20 and >50
• Systemic disorders
• Articaine Allergy
• Inability to take paracetamol.
• Pregnancy or Nursing
• Symptomatic pulpitis.
• Pulp necrosis
• PDL is widening.
• Periapical radiolucency
• The sinus tract
• Periapical abscesses.
• Existence of resorption
• Tooth malposition.
• Fixed partial dentures.
• Analgesics intake in the last 12 hours.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20 participants treated with Fanta (Pepsi gold) (FPG); aged 20 to 50 years	Procedure: Fanta (Pepsi gold) (FPG); endodontic treatment of posterior teeth with Fanta (Pepsi gold) (FPG)
Experimental: 20 participants treated with M3-pro+ Gold (assorted) (MPG) rotary files; aged 20 to 50 years	Procedure: M3-pro+ Gold (assorted) (MPG); endodontic treatment of posterior teeth with M3-pro+ Gold (assorted) (MPG) rotary files.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparing the intensity of post-instrumentation pain	Participants were asked to assign a Visual Analoge Scale (VAS) score to their reported pain. The existence or absence of pain was classified into four groups: no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10), following endodontic treatment of posterior teeth with Fanta (Pepsi gold) (FPG) and M3-pro+ Gold (assorted) (MPG) rotary files.	The patients were referred for treatment over a period of 7 months from November 2021-May 2022.

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Director: Faten Ghonimy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Approval number 36.3.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No