PainNCT02621034
Comparative Evaluation of Post-endodontic Pain Using Two Rotary Instrumentation Systems
A study testing Reciproc and One shape in people with Pain, run by Zahedan University of Medical Sciences at 1 site in Iran.
Trial summary
In this study the investigators aim to compare the post-operative pain using two single-file endodontic rotary systems : Reciproc and One shape. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Reciproc and One shape
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIran
- Study dates
- Dec 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systematically healthy patients
- First or second molars with irreversible pulpitis without periapical pathosis.
- Single visit endodontic treatment
Who cannot join
- Root canal retreatment
- Pregnancy
- The presence of a difficult root canal anatomy
- Internal or external resorption
- Teeth with open apices
- Any accident of complication occurred during treatment
- Presence of periapical lesion, abscess or sinus tract
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Post-endodontic Pain Using Reciproc and Oneshape Rotary Instrumentation Systems: A Randomized Clinical Trial
In this study the investigators aim to compare the post-operative pain using two single-file endodontic rotary systems : Reciproc and One shape.
Read the detailed description
Comparison of the post operative pain with two rotary systems including Reciproc and One shape.
Confounding factors were neutralized and the rotary systems were compared.
- Conditions
- Pain
- Being tested
- Control, Reciproc, One shape
- Keywords
- Root canal treatment, pain, endodontic instruments
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlProcedure or surgery
K-file hand instrumentation
ReciprocProcedure or surgery
reciprocating rotary instrument
One shapeProcedure or surgery
full rotation protocol
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | K-file hand instrumentation Receives: Procedure: Control |
| Reciproc | Experimental | rotary reciprocating protocol Receives: Procedure: Reciproc |
| One shape | Experimental | one shape continuous rotation protocol Receives: Procedure: One shape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval
The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).
Measured: 6 hours
Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals
Measured: 72 hours
Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahedan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eshagh Ali Saberi, DDS,MS, Study director, Head of the department of Endodontics, Zahedan university of medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621034
- Sponsor's protocol ID
- SRH-1
- Status last verified
- Mar 2016
- First submitted
- 29 Nov 2015
- Last updated
- 6 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-endodontic Pain Using Reciproc and Oneshape Rotary Instrumentation Systems: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02621034
- Acronym / sponsor ID
- SRH-1
- Conditions
- Pain
- Keywords
- Root canal treatment, pain, endodontic instruments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zahedan University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Posted 6 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators aim to compare the post-operative pain using two single-file endodontic rotary systems : Reciproc and One shape.
Detailed description
Comparison of the post operative pain with two rotary systems including Reciproc and One shape.
Confounding factors were neutralized and the rotary systems were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Procedure: ControlK-file hand instrumentation |
| Reciproc | Experimental | Procedure: Reciprocrotary reciprocating protocol |
| One shape | Experimental | Procedure: One shapeone shape continuous rotation protocol |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Systematically healthy patients
- First or second molars with irreversible pulpitis without periapical pathosis.
- Single visit endodontic treatment
Key exclusion criteria (7 listed)
- Root canal retreatment
- Pregnancy
- The presence of a difficult root canal anatomy
- Internal or external resorption
- Teeth with open apices
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 |
|---|---|---|
| ControlK-file hand instrumentation | Procedure or surgery | Control |
| Reciprocreciprocating rotary instrument | Procedure or surgery | Reciproc |
| One shapefull rotation protocol | Procedure or surgery | One shape |
Primary outcome
Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval
Time frame: 6 hours
The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).
Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals
Time frame: 72 hours
Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval
Time frame: 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Eshagh Ali Saberi, DDS,MS study director
Head of the department of Endodontics, Zahedan university of medical sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reciproc and One shape in people with Pain, run by Zahedan University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 7 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 6 Jun 2016. 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 Iran. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval (time frame: 6 hours). The study lists 3 primary outcomes in all. 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 6 Jun 2016.