Symptomatic Irreversible PulpitisNCT06777381
Comparison of Post-Operative Pain Occurrence After Single Visit Root Canal Treatment
A study testing single visit root canal treatment using ProTaper Universal rotary system and single visit root canal treatment using M-Pro rotary system in people with Symptomatic Irreversible Pulpitis, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the post-operative pain occurrence after single visit root canal treatment using Two NiTi Rotary Files. The main question it aims to answer is: Does an instrument design and instrumentation technique could affect postoperative pain incidence and intensity? Researchers will… Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- single visit root canal treatment using ProTaper Universal rotary system and single visit root canal treatment using M-Pro rotary system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient's diagnosis is symptomatic irreversible pulpitis in mandibular first molar.
- Males and females patients in a good health.
- Aged from 25 to 45 years old.
- Pulp vitality is confirmed with cold pulp test and an electric pulp test.
Who cannot join
- Pregnant females.
- Patients complaining from pain in more than one molar on the same side.
- Patients whose teeth react positively to percussion test.
- Patients who receive analgesics 12 hours before the start of the root canal treatment.
- Teeth having grade 2 or 3 mobility.
- Presence of periapical radiolucency or teeth with extra oral or intraoral sinus tract or fistula.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Dental Clinic at Medical Research Centre of Excellence, National Research Centre
Cairo
About this study
Official title: Comparison of Post-Operative Pain Occurrence After Single Visit Root Canal Treatment with Two NiTi Rotary Files - a Randomized Clinical Trial
The goal of this clinical trial is to compare the post-operative pain occurrence after single visit root canal treatment using Two NiTi Rotary Files. The main question it aims to answer is:
- Does an instrument design and instrumentation technique could affect postoperative pain incidence and intensity? Researchers will use ProTaper Universal rotary system or M-Pro rotary system for root canal preparation and compared postoperative pain intensity.
Read more
Participants will receive single visit endodontic treatment using either ProTaper or MPro systems for root canal preparation.
Participants will record Pain intensity at 24 hours and 7 days post-operative. Analgesics will be prescribed for the patients in need.
Read the detailed description
The main cause of patient fear is expecting pain during root canal treatment. It is considered a major concern for dentists as well. During root canal preparation, periapical extrusion of pulpal tissue remnants, microorganisms or dentin chips may be one of the causes of postoperative pain. Depending on the fact that, instrument design and instrumentation techniques have an impact on the amount of extruded debris apically, many studies proved the ability of some rotary systems to reduce debris extrusion, permitting to achieve less pain sensation.
Therefore, the present clinical study aims to compare the postoperative pain intensity in molars with symptomatic irreversible pulpitis after single endodontic treatment visit using a full-sequence rotary Ni-Ti system either ProTaper or MPro systems Eighty patients with symptomatic irreversible pulpitis in mandibular first molars will be assigned into two groups. In group A (n=40): root canal preparation will be performed in single visit using ProTaper Universal system and in group B (n=40): root canal preparation will be performed in single visit using M-Pro rotary system. Pain intensity will be recorded by the patient using Numerical Rating Scale (NRS) at 24 hours and 7 days postoperative. Analgesics will be prescribed for the patients in case of need.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- single visit root canal treatment using ProTaper Universal rotary system, single visit root canal treatment using M-Pro rotary system
- Keywords
- post-operative pain, ProTaper, M-Pro, single visit
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single visit root canal treatment using ProTaper Universal rotary systemProcedure or surgery
single visit endodontic treatment will be performed using ProTaper Universal rotary system for root canal preparation.
single visit root canal treatment using M-Pro rotary systemProcedure or surgery
single visit endodontic treatment will be performed using MPro rotary systems for root canal preparation.
| Study group | Role | What they receive |
|---|---|---|
| Group A: ProTaper Universal system | Experimental | root canal treatment will be performed in single visit using ProTaper Universal system Receives: Procedure: single visit root canal treatment using ProTaper Universal rotary system |
| Group B: M-Pro rotary system | Experimental | root canal treatment will be performed in single visit using M-Pro rotary system Receives: Procedure: single visit root canal treatment using M-Pro rotary system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Record the intensity of postoperative pain after root canal treatment with ProTaper Universal and M-Pro endodontic rotary files.
Pain intensity will be recorded by the patient 24 hours and 7 days postoperatively. Pain assessment is evaluated using 10-point Numerical Rating Scale, where the endpoints are the extremes of no pain and worst pain. The severity of pain is assigned as follows: (0) equivalent to none/ (1) equivalent to slight pain / (2) equivalent to moderate pain and (3) equivalent to severe pain.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start25 Oct 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Irreversible PulpitisStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira lbrahim Mohamed, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777381
- Sponsor's protocol ID
- 03460224
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Khallaf ME, Aly Y, Mohamed AI. Comparison of post-operative pain prevalence after single visit endodontic treatment with two NiTi rotary files - a randomized clinical trial. Sci Rep. 2025 Dec 18;15(1):44128. doi: 10.1038/s41598-025-29029-8.
PubMed 41413418
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-Operative Pain Occurrence After Single Visit Root Canal Treatment with Two NiTi Rotary Files - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06777381
- Acronym / sponsor ID
- 03460224
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- post-operative pain, ProTaper, M-Pro, single visit
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 15 Jan 2025 (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.
The goal of this clinical trial is to compare the post-operative pain occurrence after single visit root canal treatment using Two NiTi Rotary Files. The main question it aims to answer is:
- Does an instrument design and instrumentation technique could affect postoperative pain incidence and intensity? Researchers will use ProTaper Universal rotary system or M-Pro rotary system for root canal preparation and compared postoperative pain intensity.
Participants will receive single visit endodontic treatment using either ProTaper or MPro systems for root canal preparation.
Participants will record Pain intensity at 24 hours and 7 days post-operative. Analgesics will be prescribed for the patients in need.
Detailed description
The main cause of patient fear is expecting pain during root canal treatment. It is considered a major concern for dentists as well. During root canal preparation, periapical extrusion of pulpal tissue remnants, microorganisms or dentin chips may be one of the causes of postoperative pain. Depending on the fact that, instrument design and instrumentation techniques have an impact on the amount of extruded debris apically, many studies proved the ability of some rotary systems to reduce debris extrusion, permitting to achieve less pain sensation.
Therefore, the present clinical study aims to compare the postoperative pain intensity in molars with symptomatic irreversible pulpitis after single endodontic treatment visit using a full-sequence rotary Ni-Ti system either ProTaper or MPro systems Eighty patients with symptomatic irreversible pulpitis in mandibular first molars will be assigned into two groups. In group A (n=40): root canal preparation will be performed in single visit using ProTaper Universal system and in group B (n=40): root canal preparation will be performed in single visit using M-Pro rotary system. Pain intensity will be recorded by the patient using Numerical Rating Scale (NRS) at 24 hours and 7 days postoperative. Analgesics will be prescribed for the patients in case of need.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: ProTaper Universal system | Experimental | Procedure: single visit root canal treatment using ProTaper Universal rotary systemroot canal treatment will be performed in single visit using ProTaper Universal system |
| Group B: M-Pro rotary system | Experimental | Procedure: single visit root canal treatment using M-Pro rotary systemroot canal treatment will be performed in single visit using M-Pro rotary system |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient's diagnosis is symptomatic irreversible pulpitis in mandibular first molar.
- Males and females patients in a good health.
- Aged from 25 to 45 years old.
- Pulp vitality is confirmed with cold pulp test and an electric pulp test.
Key exclusion criteria (6 listed)
- Pregnant females.
- Patients complaining from pain in more than one molar on the same side.
- Patients whose teeth react positively to percussion test.
- Patients who receive analgesics 12 hours before the start of the root canal treatment.
- Teeth having grade 2 or 3 mobility.
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 |
|---|---|---|
| single visit root canal treatment using ProTaper Universal rotary systemsingle visit endodontic treatment will be performed using ProTaper Universal rotary system for root canal preparation. | Procedure or surgery | Group A: ProTaper Universal system |
| single visit root canal treatment using M-Pro rotary systemsingle visit endodontic treatment will be performed using MPro rotary systems for root canal preparation. | Procedure or surgery | Group B: M-Pro rotary system |
Primary outcome
Record the intensity of postoperative pain after root canal treatment with ProTaper Universal and M-Pro endodontic rotary files.
Time frame: 7 days
Pain intensity will be recorded by the patient 24 hours and 7 days postoperatively. Pain assessment is evaluated using 10-point Numerical Rating Scale, where the endpoints are the extremes of no pain and worst pain. The severity of pain is assigned as follows: (0) equivalent to none/ (1) equivalent to slight pain / (2) equivalent to moderate pain and (3) equivalent to severe pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Derived from this study: PubMed 41413418Khallaf ME, Aly Y, Mohamed AI. Comparison of post-operative pain prevalence after single visit endodontic treatment with two NiTi rotary files - a randomized clinical trial. Sci Rep. 2025 Dec 18;15(1):44128. doi: 10.1038/s41598-025-29029-8.
- 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.
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 single visit root canal treatment using ProTaper Universal rotary system and single visit root canal treatment using M-Pro rotary system in people with Symptomatic Irreversible Pulpitis, run by National Research Centre, Egypt 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 4 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 15 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Record the intensity of postoperative pain after root canal treatment with ProTaper Universal and M-Pro endodontic rotary files. (time frame: 7 days). 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 NCT06777381, which also lists 1 linked publication.
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 15 Jan 2025.