Acute PulpitisNCT03065777
Postoperative Pain Associated With Three Endodontic Rotary Systems
A study testing ONE ENDO, F6 SKYTaper and ProTaper Universal in people with Acute Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
Assessment of postoperative pain after root canal treatment using different rotary systems. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pulpitis
- What is being tested?
- ONE ENDO, F6 SKYTaper and ProTaper Universal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2016to Dec 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systematically healthy patients,
- maxillary or mandibular premolar teeth with acute irreversible pulpitis and indicated for conventional endodontic treatment.
Who cannot join
- Non-vital teeth,
- teeth with apical periodontitis,
- teeth requiring endodontic retreatment,
- root resorption,
- immature / open apex,
- root canals with radiographic evidence of calcification,
Show all 14Show fewer
- presence of more than one symptomatic tooth in the same quadrant,
- pregnancy,
- medically compromised patients,
- patients receiving medication for chronic pain,
- patients who have taken analgesics in the last 12 hours before treatment.
- teeth that have initial apical size more than 20,
- teeth that could not be treated in a single session,
- if any evidence of extrusion of root filling material noticed radiographically, patient will be excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and Dental Medicine - Cairo University
Cairo
About this study
Official title: Evaluation of Postoperative Pain After Single Visit Root Canal Treatment Associated With The Three Rotary Systems; ONE ENDO, F6 SkyTper and ProTaper Universal. (Randomized Controlled Clinical Trial)
Assessment of postoperative pain after root canal treatment using different rotary systems.
Read the detailed description
Randomized controlled clinical trial comparing three types of endodontic rotary files to assess their effect on postoperative pain after single visit root canal treatment of premolar teeth diagnosed with acute irreversible pulpitis.
- Conditions
- Acute Pulpitis
- Being tested
- ONE ENDO, F6 SKYTaper, ProTaper Universal
- Keywords
- single file., ONE ENDO., F6 SkyTaper., ProTaper Universal., irreversible pulpitis., postoperative pain.
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONE ENDODevice
single file rotary system
F6 SKYTaperDevice
single file rotary system
ProTaper UniversalDevice
multi-file rotary system
| Study group | Role | What they receive |
|---|---|---|
| ONE ENDO | Experimental | Single file rotary system Receives: Device: ONE ENDO |
| F6 SKYTaper | Experimental | Single file rotary system Receives: Device: F6 SKYTaper |
| ProTaper Universal | Active comparator | Muti-file rotary system Receives: Device: ProTaper Universal |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Verbal Rating Scale (VRS) with the following scores:
- No pain.
- Mild pain: any discomfort of any duration that does not require analgesics.
- Moderate pain: pain that requires and is relieved with analgesics.
- Severe pain: any pain that is not relieved with analgesics.
Measured: up to 72 hours after endodontic treatment
Secondary outcomes (1)
Number of analgesics consumed
Measured: up to 72 hours after endodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study startOct 2016
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Adel Hassan Hafez, Cairo University
- Investigators
- Ola A. Hafez, MD Student, Principal investigator, Faculty of Oral and Dental Medicine - Cairo UniversityAlaa El-Din H. Diab, Professor, Study chair, Faculty of Oral and Dental Medicine - Cairo UniversityKareem G. Abd El-Kader, Assistant Professor, Study director, Faculty of Oral and Dental Medicine - Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065777
- Sponsor's protocol ID
- CEBC-CU-2016-11-173
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2017
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Pain After Single Visit Root Canal Treatment Associated With The Three Rotary Systems; ONE ENDO, F6 SkyTper and ProTaper Universal. (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT03065777
- Acronym / sponsor ID
- CEBC-CU-2016-11-173
- Conditions
- Acute Pulpitis
- Keywords
- single file., ONE ENDO., F6 SkyTaper., ProTaper Universal., irreversible pulpitis., postoperative pain.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Feb 2017 (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.
Assessment of postoperative pain after root canal treatment using different rotary systems.
Detailed description
Randomized controlled clinical trial comparing three types of endodontic rotary files to assess their effect on postoperative pain after single visit root canal treatment of premolar teeth diagnosed with acute irreversible pulpitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ONE ENDO | Experimental | Device: ONE ENDOSingle file rotary system |
| F6 SKYTaper | Experimental | Device: F6 SKYTaperSingle file rotary system |
| ProTaper Universal | Active comparator | Device: ProTaper UniversalMuti-file rotary system |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Systematically healthy patients,
- maxillary or mandibular premolar teeth with acute irreversible pulpitis and indicated for conventional endodontic treatment.
Key exclusion criteria (14 listed)
- Non-vital teeth,
- teeth with apical periodontitis,
- teeth requiring endodontic retreatment,
- root resorption,
- immature / open apex,
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 |
|---|---|---|
| ONE ENDOsingle file rotary system | Device | ONE ENDO |
| F6 SKYTapersingle file rotary system | Device | F6 SKYTaper |
| ProTaper Universalmulti-file rotary system | Device | ProTaper Universal |
Primary outcome
postoperative pain
Time frame: up to 72 hours after endodontic treatment
Verbal Rating Scale (VRS) with the following scores: 0. No pain. 1. Mild pain: any discomfort of any duration that does not require analgesics. 2. Moderate pain: pain that requires and is relieved with analgesics. 3. Severe pain: any pain that is not relieved with analgesics.
1 secondary outcome
Number of analgesics consumed
Time frame: up to 72 hours after endodontic treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Acute Pulpitis
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Vital Pulp Therapy Versus Root Canal Treatment for Irreversible Pulpitis With Incipient Apical Periodontitis Diagnosed Using Artificial Intelligence This Keeps: the Main Intervention (Vital Pulp Therapy) the Comparison (Root Canal Treatment) the Condition (Irreversible Pulpitis With Incipient Apic
Symptomatic Irreversible Pulpitis
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To Evaluate Post Operative Pain Using Two Different Kind of Sealers in Obturation of Teeth With Symptomatic Irreversible Pulpitis During Second Visit When the Patient is Painless
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Comparison of Aquaporin -4, -5, -9 and IL-8 Levels in GCF, Dentin Fluid and Pulp Samples
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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.
Ola A. Hafez, MD Student principal investigator
Faculty of Oral and Dental Medicine - Cairo University
Alaa El-Din H. Diab, Professor study chair
Faculty of Oral and Dental Medicine - Cairo University
Kareem G. Abd El-Kader, Assistant Professor study director
Faculty of Oral and Dental Medicine - Cairo 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 ONE ENDO, F6 SKYTaper and ProTaper Universal in people with Acute 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 2 inclusion and 14 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 28 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ola A. Hafez, MD Student (0021111626076, olahafez2010@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: up to 72 hours after endodontic treatment). 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 28 Feb 2017.