Endodontic TreatmentNCT06382545
Post-instrumentation Pain After Use of the Fanta and M3 Pro Gold Systems
A study testing Fanta (Pepsi gold) (FPG) and M3-pro+ Gold (assorted) (MPG) in people with Endodontic Treatment, run by Ahram Canadian University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Treatment
- What is being tested?
- Fanta (Pepsi gold) (FPG) and M3-pro+ Gold (assorted) (MPG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-50 years old
- No systemic diseases
- Mandibular first molar
- Asymptomatic tooth
- Normal periapical film
- Restorable teeth
- Periodontal scoring index <2
Who cannot join
- Age <20 and >50
- Systemic disorders
- Articaine Allergy
- Inability to take paracetamol.
- Pregnancy or Nursing
- Symptomatic pulpitis.
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- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental medicine, Ahram Canadian University
Giza, 12573
About this study
Official title: 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.
- Conditions
- Endodontic Treatment
- Being tested
- Fanta (Pepsi gold) (FPG), M3-pro+ Gold (assorted) (MPG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fanta (Pepsi gold) (FPG)Procedure or surgery
endodontic treatment of posterior teeth with Fanta (Pepsi gold) (FPG)
M3-pro+ Gold (assorted) (MPG)Procedure or surgery
endodontic treatment of posterior teeth with M3-pro+ Gold (assorted) (MPG) rotary files.
| Study group | Role | What they receive |
|---|---|---|
| 20 participants treated with Fanta (Pepsi gold) (FPG) | Experimental | aged 20 to 50 years Receives: Procedure: Fanta (Pepsi gold) (FPG) |
| 20 participants treated with M3-pro+ Gold (assorted) (MPG) rotary files | Experimental | aged 20 to 50 years Receives: Procedure: M3-pro+ Gold (assorted) (MPG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The patients were referred for treatment over a period of 7 months from November 2021-May 2022.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Nov 2021
- Primary completion30 Jun 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faten Mohamed Ahmed Ghonimy, Ahram Canadian University
- Investigators
- Faten Ghonimy, Study director, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382545
- Sponsor's protocol ID
- Approval number 36.3.22
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-instrumentation Pain After Use of the Fanta and M3 Pro Gold Systems: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06382545
- Acronym / sponsor ID
- Approval number 36.3.22
- Conditions
- Endodontic Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 participants treated with Fanta (Pepsi gold) (FPG) | Experimental | Procedure: Fanta (Pepsi gold) (FPG)aged 20 to 50 years |
| 20 participants treated with M3-pro+ Gold (assorted) (MPG) rotary files | Experimental | Procedure: M3-pro+ Gold (assorted) (MPG)aged 20 to 50 years |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 20-50 years old
- No systemic diseases
- Mandibular first molar
- Asymptomatic tooth
- Normal periapical film
Key exclusion criteria (15 listed)
- Age <20 and >50
- Systemic disorders
- Articaine Allergy
- Inability to take paracetamol.
- Pregnancy or Nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fanta (Pepsi gold) (FPG)endodontic treatment of posterior teeth with Fanta (Pepsi gold) (FPG) | Procedure or surgery | 20 participants treated with Fanta (Pepsi gold) (FPG) |
| M3-pro+ Gold (assorted) (MPG)endodontic treatment of posterior teeth with M3-pro+ Gold (assorted) (MPG) rotary files. | Procedure or surgery | 20 participants treated with M3-pro+ Gold (assorted) (MPG) rotary files |
Primary outcome
comparing the intensity of post-instrumentation pain
Time frame: The patients were referred for treatment over a period of 7 months from November 2021-May 2022.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faten Ghonimy study director
Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fanta (Pepsi gold) (FPG) and M3-pro+ Gold (assorted) (MPG) in people with Endodontic Treatment, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing the intensity of post-instrumentation pain (time frame: The patients were referred for treatment over a period of 7 months from November 2021-May 2022.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.