PulpitisNCT03694743
Post-operative Pain in 2Shape Versus Protaper Next Rotary Systems
A study testing 2Shape rotary system in people with Pulpitis, run by Cairo University.
Trial summary
Pain after endodontic treatment is considered the most disturbing problem facing both the patient and the dentist especially in cases of symptomatic pulpitis as the patient is expecting to relief the pain that already exists.Therefore, this study aims to find a solution for the post-operative pain felt by the patient… Read more about this study
- Who is it for?
- Ages 22 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis
- What is being tested?
- 2Shape rotary system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Oct 2020
- 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 22 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Medically free patients.
- Patients with symptomatic pulpitis in one of their mandibular molars.
- Patient's age ranges between 22 to 45 years with no sex predilection.
- Patients who can understand Numerical Analogue Scales (NRS).
- Patients able to sign informed consent.
Who cannot join
- - Patients having a systemic disorder.
- Presence of periapical lesion.
- Pregnant females.
- Patients who had taken analgesics during the last 12 hours preoperatively.
- Patients having active pain in more than one tooth.
- Non- educated patients.
About this study
Official title: Assessment of Postoperative Pain After Using 2Shape and Protaper Next Rotary Systems in Patients With Symptomatic Pulpitis in Mandibular Molars:A Randomized Clinical Trial
Pain after endodontic treatment is considered the most disturbing problem facing both the patient and the dentist especially in cases of symptomatic pulpitis as the patient is expecting to relief the pain that already exists.Therefore, this study aims to find a solution for the post-operative pain felt by the patient with symptomatic pulpitis in mandibular molars through comparing post-operative pain following use of 2Shape and Protaper Next rotary systems.
Read the detailed description
Root canal preparation is the most important step in endodontic treatment. For successful treatment, pulp tissue, dentin debris and microorganisms should be completely eradicated from the root canal system.However, it has been reported that all the instrumentation techniques (manual or mechanical) cause debris extrusion into the periradicular tissue resulting in periapical inflammation that causes post-operative pain and flare up.
Instrumentation technique and instrument design were found to be related to the amount of debris extruded which is the main cause of post-operative pain. It has been reported that rotary NiTi systems cause less debris extrusion than manual instrumentation.
Within NiTi systems, instrument design, taper and tip size were found to affect debris extrusion. Therefore, new innovations in the instrument designs are introduced in order to reduce post-operative pain and flare up incidence.
Therefore, this study is established to compare the effect of 2 different rotary systems on postoperative pain in patients with symptomatic pulpitis.
The aim of the present study is to assess the effect of rotary instrumentation using Protaper Next rotary system versus 2Shape rotary system on postoperative pain and the number of analgesics taken by the patient following single visit root canal treatment in mandibular molars with symptomatic pulpitis.
Primary objective:
Comparing the intensity of post-operative pain using Numerical Rating Scale (NRS) immediately after root canal treatment and post-appointment at 6, 12, 24, 48 and 72hours.
Secondary objectives:
- The need for / and number of analgesic tablets taken within 3 days after end of endodontic treatment.
- Instrument separation during instrumentation.
- Conditions
- Pulpitis
- Being tested
- 2Shape rotary system
- Keywords
- mandibular molars
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2Shape rotary systemDevice
root canal preparation
| Study group | Role | What they receive |
|---|---|---|
| 2Shape rotary system | Experimental | root canal preparation using 2Shape rotary system in mandibular molars with symptomatic pulpitis Receives: Device: 2Shape rotary system |
| Protaper Next rotary system | Active comparator | root canal preparation using Protaper Next rotary system comparing to 2Shape rotary system in mandibular molars with symptomatic pulpitis Receives: Device: 2Shape rotary system |
What is being measured
The primary outcome is the main question the study is designed to answer.
intensity of postoperative pain assessed by numerical rating scale Immediately after the end of treatment, and at 6, 12, 24, 48, and 72 hours. post-operative pain
using numerical rating scale ranges between (0-10) where 0 indicates no pain while 10 indicates maximum pain degree
Measured: 3 days
Secondary outcomes (1)
Need for / and number of analgesic tablets taken.
incidence and number of analgesic tablets will be recorded
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study startDec 2018 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ibrahim Mohamady, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694743
- Sponsor's protocol ID
- dentistry cairo
- Status last verified
- Sep 2018
- First submitted
- 29 Sep 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Pain After Using 2Shape and Protaper Next Rotary Systems in Patients With Symptomatic Pulpitis in Mandibular Molars:A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03694743
- Acronym / sponsor ID
- dentistry cairo
- Conditions
- Pulpitis
- Keywords
- mandibular molars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 3 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.
Pain after endodontic treatment is considered the most disturbing problem facing both the patient and the dentist especially in cases of symptomatic pulpitis as the patient is expecting to relief the pain that already exists.Therefore, this study aims to find a solution for the post-operative pain felt by the patient with symptomatic pulpitis in mandibular molars through comparing post-operative pain following use of 2Shape and Protaper Next rotary systems.
Detailed description
Root canal preparation is the most important step in endodontic treatment. For successful treatment, pulp tissue, dentin debris and microorganisms should be completely eradicated from the root canal system.However, it has been reported that all the instrumentation techniques (manual or mechanical) cause debris extrusion into the periradicular tissue resulting in periapical inflammation that causes post-operative pain and flare up.
Instrumentation technique and instrument design were found to be related to the amount of debris extruded which is the main cause of post-operative pain. It has been reported that rotary NiTi systems cause less debris extrusion than manual instrumentation.
Within NiTi systems, instrument design, taper and tip size were found to affect debris extrusion. Therefore, new innovations in the instrument designs are introduced in order to reduce post-operative pain and flare up incidence.
Therefore, this study is established to compare the effect of 2 different rotary systems on postoperative pain in patients with symptomatic pulpitis.
The aim of the present study is to assess the effect of rotary instrumentation using Protaper Next rotary system versus 2Shape rotary system on postoperative pain and the number of analgesics taken by the patient following single visit root canal treatment in mandibular molars with symptomatic pulpitis.
Primary objective:
Comparing the intensity of post-operative pain using Numerical Rating Scale (NRS) immediately after root canal treatment and post-appointment at 6, 12, 24, 48 and 72hours.
Secondary objectives:
- The need for / and number of analgesic tablets taken within 3 days after end of endodontic treatment.
- Instrument separation during instrumentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2Shape rotary system | Experimental | Device: 2Shape rotary systemroot canal preparation using 2Shape rotary system in mandibular molars with symptomatic pulpitis |
| Protaper Next rotary system | Active comparator | Device: 2Shape rotary systemroot canal preparation using Protaper Next rotary system comparing to 2Shape rotary system in mandibular molars with symptomatic pulpitis |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- - Medically free patients.
- Patients with symptomatic pulpitis in one of their mandibular molars.
- Patient's age ranges between 22 to 45 years with no sex predilection.
- Patients who can understand Numerical Analogue Scales (NRS).
- Patients able to sign informed consent.
Key exclusion criteria (6 listed)
- - Patients having a systemic disorder.
- Presence of periapical lesion.
- Pregnant females.
- Patients who had taken analgesics during the last 12 hours preoperatively.
- Patients having active pain in more than one tooth.
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 |
|---|---|---|
| 2Shape rotary systemroot canal preparation | Device | 2Shape rotary system, Protaper Next rotary system |
Primary outcome
intensity of postoperative pain assessed by numerical rating scale Immediately after the end of treatment, and at 6, 12, 24, 48, and 72 hours. post-operative pain
Time frame: 3 days
using numerical rating scale ranges between (0-10) where 0 indicates no pain while 10 indicates maximum pain degree
1 secondary outcome
Need for / and number of analgesic tablets taken.
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 2Shape rotary system in people with Pulpitis, run by Cairo University.
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 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: status not confirmed, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
intensity of postoperative pain assessed by numerical rating scale Immediately after the end of treatment, and at 6, 12, 24, 48, and 72 hours. post-operative pain (time frame: 3 days). 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 3 Oct 2018.