PainNCT02442388
Postoperative Pain of Root Canal Therapy With Three Techniques
A study testing Instrumentation technique with hand file, Instrumentation technique with ProTaper and Instrumentation technique with WaveOne in people with Pain, run by Shahid Beheshti University of Medical Sciences.
Trial summary
The purpose of this prospective, randomized, double-blind study was to compare the prospective pain in asymptomatic mandibular molar teeth with necrotic pulp and periapical lesion using three different instrumentation files: Hand, Protaper Universal, and Wave-One files. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Instrumentation technique with hand file, Instrumentation technique with ProTaper and Instrumentation technique with WaveOne
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2014
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patient
Who cannot join
- Allergy to anesthetics, pregnancy, breastfeeding, vital teeth, unrestorable teeth, and teeth associated with pain or swelling
About this study
The purpose of this prospective, randomized, double-blind study was to compare the prospective pain in asymptomatic mandibular molar teeth with necrotic pulp and periapical lesion using three different instrumentation files: Hand, Protaper Universal, and Wave-One files.
Read the detailed description
ProTaper Universal system is one of the conventional multi-file rotary systems that prepared root canals with six files: three shaping files and three finishing files. A unique design element is varying tapers along the instruments' long axes. The three shaping files have tapers that increase coronally, and the reverse pattern is seen in the five finishing files. Wave-One is reciprocation-based systems that instrumented root canals with only single file. Some studies demonstrated that it has outperformed conventional continuous rotary nickel-titanium (NiTi) preparation in some aspects. The reciprocating motion of Wave-One relieves the stress on the file by special counterclockwise (cutting action) and clockwise (release of the instrument) movements and, therefore, extends the durability of a NiTi instrument and increases its fatigue resistance in comparison with continuous rotation motion.
- Conditions
- Pain
- Being tested
- Instrumentation technique with hand file, Instrumentation technique with ProTaper, Instrumentation technique with WaveOne
- Keywords
- pain, root canal therapy, endodontics, file
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumentation technique with hand fileProcedure or surgery
type of instrumentation technique for root canal treatment
Instrumentation technique with ProTaperProcedure or surgery
type of instrumentation technique for root canal treatment
Instrumentation technique with WaveOneProcedure or surgery
type of instrumentation technique for root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| Hand file | Experimental | Instrumentation technique Receives: Procedure: Instrumentation technique with hand file |
| ProTaper file | Experimental | Instrumentation technique Receives: Procedure: Instrumentation technique with ProTaper |
| Wave-One file | Experimental | Instrumentation technique Receives: Procedure: Instrumentation technique with WaveOne |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as assessed by Heft-Parker VAS
Pain as assessed by Heft-Parker VAS
Measured: After each technique, up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Shokraneh, DDS, MS, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442388
- Sponsor's protocol ID
- 9308
- Status last verified
- May 2015
- First submitted
- 7 May 2015
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain of Root Canal Therapy With Three Techniques
- ClinicalTrials.gov ID
- NCT02442388
- Acronym / sponsor ID
- 9308
- Conditions
- Pain
- Keywords
- pain, root canal therapy, endodontics, file
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 May 2015 (estimated)
- 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 purpose of this prospective, randomized, double-blind study was to compare the prospective pain in asymptomatic mandibular molar teeth with necrotic pulp and periapical lesion using three different instrumentation files: Hand, Protaper Universal, and Wave-One files.
Detailed description
ProTaper Universal system is one of the conventional multi-file rotary systems that prepared root canals with six files: three shaping files and three finishing files. A unique design element is varying tapers along the instruments' long axes. The three shaping files have tapers that increase coronally, and the reverse pattern is seen in the five finishing files. Wave-One is reciprocation-based systems that instrumented root canals with only single file. Some studies demonstrated that it has outperformed conventional continuous rotary nickel-titanium (NiTi) preparation in some aspects. The reciprocating motion of Wave-One relieves the stress on the file by special counterclockwise (cutting action) and clockwise (release of the instrument) movements and, therefore, extends the durability of a NiTi instrument and increases its fatigue resistance in comparison with continuous rotation motion.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hand file | Experimental | Procedure: Instrumentation technique with hand fileInstrumentation technique |
| ProTaper file | Experimental | Procedure: Instrumentation technique with ProTaperInstrumentation technique |
| Wave-One file | Experimental | Procedure: Instrumentation technique with WaveOneInstrumentation technique |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy patient
Key exclusion criteria (1 listed)
- Allergy to anesthetics, pregnancy, breastfeeding, vital teeth, unrestorable teeth, and teeth associated with pain or swelling
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 |
|---|---|---|
| Instrumentation technique with hand filetype of instrumentation technique for root canal treatment | Procedure or surgery | Hand file |
| Instrumentation technique with ProTapertype of instrumentation technique for root canal treatment | Procedure or surgery | ProTaper file |
| Instrumentation technique with WaveOnetype of instrumentation technique for root canal treatment | Procedure or surgery | Wave-One file |
Primary outcome
Pain as assessed by Heft-Parker VAS
Time frame: After each technique, up to 72 hours
Pain as assessed by Heft-Parker VAS
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 13 May 2015.
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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 Instrumentation technique with hand file, Instrumentation technique with ProTaper and Instrumentation technique with WaveOne in people with Pain, run by Shahid Beheshti University of Medical Sciences.
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 1 inclusion and 1 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 13 May 2015. 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?
Pain as assessed by Heft-Parker VAS (time frame: After each technique, up to 72 hours). 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 13 May 2015.