Symptomatic Irreversible PulpitisNCT03692039
Comparison Between M-Pro and ProTaper Next
A study testing M-pro files in rotating motion and ProTaper Next files in rotating motion in people with Symptomatic Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
Comparing the postoperative pain resulting after mechanical instrumentation using M-pro files versus that resulting after using ProTaper Next rotary files in lower molar with symptomatic Irreversible pulpitis molars. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- M-pro files in rotating motion and ProTaper Next files in rotating motion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 1 Oct 2019
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1- Males or Females.
- 2- Mandibular molar teeth with:
- Pre-operative sharp pain.
- Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
- Normal periapical radiographic appearance or slight widening in lamina dura using periapical index (PAI) score 1 as normal periapical structures or 2 as small changes in bone structures.
Who cannot join
- Patients having significant systemic disorders.
- Patients who are allergic to non-steroidal anti-inflammatory drugs.
- Patients with two or more adjacent teeth requiring root canal therapy.
- Teeth that have:
- Necrotic pulp tissues.
- Association with swelling or fistulous tract.
Show all 11Show fewer
- Acute or chronic peri-apical abscess.
- Greater than grade I mobility.
- Pocket depth greater than 5mm.
- No possible restorability.
- Previous endodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Pain After Root Canal Instrumentation Using M-Pro and ProTaper Next in Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Comparing the postoperative pain resulting after mechanical instrumentation using M-pro files versus that resulting after using ProTaper Next rotary files in lower molar with symptomatic Irreversible pulpitis molars.
Read the detailed description
Lower molars with symptomatic Irreversible pulpitis molars are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using M-pro Files or ProTaper Next files. Postoperative pain is then assessed using the Numerical Rating scale 6, 12, 24, 48 and 72 hours post-operatively . After completing the treatment, patients will instructed to take placebo if they feel pain and will be asked to provide the quantity of placebo intake until 72 hrs. In case of pain not relieved by placebo, after recording the amount of pain, the patient will be instructed to take an alternative line of pain control (Ibuprofen 400mg tablets every 6 hours). The amount and frequency of Ibuprofen intake will be recorded.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- M-pro files in rotating motion, ProTaper Next files in rotating motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-pro files in rotating motionProcedure or surgery
An endodontic file that has controlled memory properties
ProTaper Next files in rotating motionProcedure or surgery
An endodontic file that has an off center mass of rotation
| Study group | Role | What they receive |
|---|---|---|
| M-pro files | Experimental | Instrumentation using M-pro files in rotating motion Receives: Procedure: M-pro files in rotating motion |
| ProTaper Next files | Active comparator | Instrumentation using ProTaper Next files in rotating motion Receives: Procedure: ProTaper Next files in rotating motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain assessed with numerical rating scale
0 (none) to 10 (severe) Numerical Pain Rating Scale up to 72 hours post-operatively
Measured: Up to 72 hours post-operatively
Secondary outcomes (2)
Incidence of placebo intake assessed by questioning
Amount of placebo intake up to 72 hours post-operatively
Measured: Up to 72 hours post-operatively
Amount of analgesic intake assessed by counting
Number of analgesic tablets up to 72 hours post-operatively
Measured: Up to 72 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Oct 2018
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- Blocks of 4 are generated on a Microsoft Excel sheet where the intervention and control are denoted A \& B and randomly distributed. The table is kept with the assistant supervisor.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Essam Othman Ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692039
- Sponsor's protocol ID
- CEBD-CU-2018-09-33
- Status last verified
- Jul 2020
- First submitted
- 29 Sep 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kocak MM, Cicek E, Kocak S, Saglam BC, Furuncuoglu F. Comparison of ProTaper Next and HyFlex instruments on apical debris extrusion in curved canals. Int Endod J. 2016 Oct;49(10):996-1000. doi: 10.1111/iej.12552. Epub 2015 Oct 12.
PubMed 26383696Ruddle CJ, Machtou P, West JD. The shaping movement: fifth-generation technology. Dent Today. 2013 Apr;32(4):94, 96-9. No abstract available.
PubMed 23659098
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain After Root Canal Instrumentation Using M-Pro and ProTaper Next in Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03692039
- Acronym / sponsor ID
- CEBD-CU-2018-09-33
- Conditions
- Symptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 2 Oct 2018 (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 postoperative pain resulting after mechanical instrumentation using M-pro files versus that resulting after using ProTaper Next rotary files in lower molar with symptomatic Irreversible pulpitis molars.
Detailed description
Lower molars with symptomatic Irreversible pulpitis molars are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using M-pro Files or ProTaper Next files. Postoperative pain is then assessed using the Numerical Rating scale 6, 12, 24, 48 and 72 hours post-operatively . After completing the treatment, patients will instructed to take placebo if they feel pain and will be asked to provide the quantity of placebo intake until 72 hrs. In case of pain not relieved by placebo, after recording the amount of pain, the patient will be instructed to take an alternative line of pain control (Ibuprofen 400mg tablets every 6 hours). The amount and frequency of Ibuprofen intake will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Blocks of 4 are generated on a Microsoft Excel sheet where the intervention and control are denoted A \& B and randomly distributed. The table is kept with the assistant supervisor.
| Arm | Type | Receives |
|---|---|---|
| M-pro files | Experimental | Procedure: M-pro files in rotating motionInstrumentation using M-pro files in rotating motion |
| ProTaper Next files | Active comparator | Procedure: ProTaper Next files in rotating motionInstrumentation using ProTaper Next files in rotating motion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1- Males or Females.
- 2- Mandibular molar teeth with:
Key exclusion criteria (11 listed)
- Patients having significant systemic disorders.
- Patients who are allergic to non-steroidal anti-inflammatory drugs.
- Patients with two or more adjacent teeth requiring root canal therapy.
- Teeth that have:
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 |
|---|---|---|
| M-pro files in rotating motionAn endodontic file that has controlled memory properties | Procedure or surgery | M-pro files |
| ProTaper Next files in rotating motionAn endodontic file that has an off center mass of rotation | Procedure or surgery | ProTaper Next files |
Primary outcome
Post operative pain assessed with numerical rating scale
Time frame: Up to 72 hours post-operatively
0 (none) to 10 (severe) Numerical Pain Rating Scale up to 72 hours post-operatively
2 secondary outcomes
Incidence of placebo intake assessed by questioning
Time frame: Up to 72 hours post-operatively
Amount of analgesic intake assessed by counting
Time frame: Up to 72 hours post-operatively
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 14 Jul 2020.
- Background: PubMed 26383696Kocak MM, Cicek E, Kocak S, Saglam BC, Furuncuoglu F. Comparison of ProTaper Next and HyFlex instruments on apical debris extrusion in curved canals. Int Endod J. 2016 Oct;49(10):996-1000. doi: 10.1111/iej.12552. Epub 2015 Oct 12.
- Background: PubMed 23659098Ruddle CJ, Machtou P, West JD. The shaping movement: fifth-generation technology. Dent Today. 2013 Apr;32(4):94, 96-9. No abstract available.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-pro files in rotating motion and ProTaper Next files in rotating motion in people with Symptomatic Irreversible Pulpitis, run by Cairo 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 5 inclusion and 11 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 14 Jul 2020. 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?
Post operative pain assessed with numerical rating scale (time frame: Up to 72 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03692039, which also lists 2 linked publications.
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 14 Jul 2020.