Post-instrumentation Pain After Use of the Fanta and M3 Pro Gold Systems
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2022
CompletedFirst Submitted
Initial submission to the registry
April 16, 2024
CompletedFirst Posted
Study publicly available on registry
April 24, 2024
CompletedApril 24, 2024
April 1, 2024
8 months
April 16, 2024
April 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
20 participants treated with Fanta (Pepsi gold) (FPG)
EXPERIMENTALaged 20 to 50 years
20 participants treated with M3-pro+ Gold (assorted) (MPG) rotary files
EXPERIMENTALaged 20 to 50 years
Interventions
endodontic treatment of posterior teeth with Fanta (Pepsi gold) (FPG)
endodontic treatment of posterior teeth with M3-pro+ Gold (assorted) (MPG) rotary files.
Eligibility Criteria
You may qualify if:
- years old
- No systemic diseases
- Mandibular first molar
- Asymptomatic tooth
- Normal periapical film
- Restorable teeth
- Periodontal scoring index \<2
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Oral and Dental medicine, Ahram Canadian University
Giza, 12573, Egypt
Study Officials
- STUDY DIRECTOR
Faten Ghonimy
Ahram Canadian University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstany Professor
Study Record Dates
First Submitted
April 16, 2024
First Posted
April 24, 2024
Study Start
November 1, 2021
Primary Completion
June 30, 2022
Study Completion
July 30, 2022
Last Updated
April 24, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share