Symptomatic Irreversible PulpitisNCT04119661
Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles
A study testing Max-i-Probe and NaviTip in people with Symptomatic Irreversible Pulpitis, run by Cairo University.
Trial summary
The aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- Max-i-Probe and NaviTip
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to May 2015
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: 16-65 year old.
- Medically free.
- Mandibular posterior teeth with symptomatic irreversible pulpitis.
- No sex predilection
Who cannot join
- Pregnant females.
- History of allergy to any medication used in the study.
- Preoperative premedication less than 6 hours before procedure.
- Cracked teeth and teeth with badly-decayed crowns.
About this study
Official title: Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles: A Randomized Clinical Trial
The aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth.
Read the detailed description
The aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth. Medical and dental history was obtained from all participants in this trial and clinical examination for teeth was performed. Participants with symptomatic irreversible pulpitis were included. After access cavity preparation, participants were randomly assigned to one of the following groups: experimental group (Max-i-Probe) or control group (NaviTip). One-visit root canal treatment was performed . Each patient received a 48-h diary to record postoperative pain. Post-operative pain was measured at the following time points: 4, 12, 24 and 48 hours after root canal treatment.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Max-i-Probe, NaviTip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Max-i-ProbeDevice
Using Max-i-Probe as endodontic needle during syringe irrigation
NaviTipDevice
Using NaviTip as endodontic needle during syringe irrigation
| Study group | Role | What they receive |
|---|---|---|
| Max-i-Probe | Experimental | Not described Receives: Device: Max-i-Probe |
| NaviTip | Active comparator | Not described Receives: Device: NaviTip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 4h after root canal treatment
Measured: 4 hours
Postoperative pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12h after root canal treatment
Measured: 12 hours
Postoperative pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 h after root canal treatment
Measured: 24 hours
Postoperative pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48h after root canal treatment
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study startJul 2012
- Primary completionMay 2015
- Study completionMay 2015
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzan AW Amin, Cairo University
- Investigators
- Suzan Amin, Professor, Study director, Cairo UniversityMohamed El-Bayoumi, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119661
- Sponsor's protocol ID
- ENDO-CU-2012-7-15
- Status last verified
- Oct 2019
- First submitted
- 6 Oct 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.
PubMed 20647083Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.
PubMed 27248848
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04119661
- Acronym / sponsor ID
- ENDO-CU-2012-7-15
- Conditions
- Symptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 8 Oct 2019 (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 aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth.
Detailed description
The aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth. Medical and dental history was obtained from all participants in this trial and clinical examination for teeth was performed. Participants with symptomatic irreversible pulpitis were included. After access cavity preparation, participants were randomly assigned to one of the following groups: experimental group (Max-i-Probe) or control group (NaviTip). One-visit root canal treatment was performed . Each patient received a 48-h diary to record postoperative pain. Post-operative pain was measured at the following time points: 4, 12, 24 and 48 hours after root canal treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Max-i-Probe | Experimental | Device: Max-i-Probe |
| NaviTip | Active comparator | Device: NaviTip |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 16-65 year old.
- Medically free.
- Mandibular posterior teeth with symptomatic irreversible pulpitis.
- No sex predilection
Key exclusion criteria (4 listed)
- Pregnant females.
- History of allergy to any medication used in the study.
- Preoperative premedication less than 6 hours before procedure.
- Cracked teeth and teeth with badly-decayed crowns.
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 |
|---|---|---|
| Max-i-ProbeUsing Max-i-Probe as endodontic needle during syringe irrigation | Device | Max-i-Probe |
| NaviTipUsing NaviTip as endodontic needle during syringe irrigation | Device | NaviTip |
Primary outcome
Postoperative pain using a pain-measuring scale
Time frame: 4 hours
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 4h after root canal treatment
Postoperative pain using a pain-measuring scale
Time frame: 12 hours
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12h after root canal treatment
Postoperative pain using a pain-measuring scale
Time frame: 24 hours
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 h after root canal treatment
Postoperative pain using a pain-measuring scale
Time frame: 48 hours
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48h after root canal treatment
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 8 Oct 2019.
- Background: PubMed 20647083Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.
- Background: PubMed 27248848Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.
- 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.
Suzan Amin, Professor study director
Cairo University
Mohamed El-Bayoumi, Professor study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Max-i-Probe and NaviTip in people with Symptomatic Irreversible 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 4 inclusion and 4 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 8 Oct 2019. 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?
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?
Postoperative pain using a pain-measuring scale (time frame: 4 hours). The study lists 4 primary outcomes in all. 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 NCT04119661, 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 8 Oct 2019.