Pain, PostoperativeNCT02644031
Evaluation of Post-endodontic Pain After Root Canal Treatment With Two Rotary Systems : Mtwo & Safe-sider
A study testing mtwo rotary system, safe-sider rotary system and hand files in people with Pain, Postoperative, run by Zahedan University of Medical Sciences at 1 site in Iran.
Trial summary
Post-endodontic pain (PP) still is major problem for endodontic patients, analgesics are routinely prescribed. Incidence of PP is reported extensively, and reviewed. PP is a complicated multi factorial process and is affected by factors related to patients, to the tooth and to the skills and experience of the dentist… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- mtwo rotary system, safe-sider rotary system and hand files
- 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?
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range 20-50 years
- the systemically healthy
- first or second molar teeth require root canal therapy
- irreversible Pulpitis signed without the apical
- root canal curvature of less than 25 degrees, according to Schneider techniques
Who cannot join
- Root canal treatment,
- history of medication (antibiotics, NSAID, opiates) of the patient 12 hours before treatment ,
- pregnancy,
- complex anatomy,
- channels blocked in the x-ray plate,
- internal and external resorption,
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- open apex teeth,
- periodontal disease,
- inflammation and abscesses,
- sinus tract,
- presence of radiographic lesions,
- tooth sensitivity to percussion,
- absence of occlusal contact .
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Zahedan University of Medical Science
Zahedan, Sistan and Baloochestan, 98176699693
arezoo hooshmandi, postgraduate, 00989177089315, hooshmandi_arezoo@yahoo.com
rohollah havaei
About this study
Post-endodontic pain (PP) still is major problem for endodontic patients, analgesics are routinely prescribed. Incidence of PP is reported extensively, and reviewed. PP is a complicated multi factorial process and is affected by factors related to patients, to the tooth and to the skills and experience of the dentist and because of that, if the interrelation of these factors is not considered in a PP, study data might be confusing. Any study trying to evaluate the effect of a specific technique or new device in the incidence or characteristics of PP should control all the confounding factors that have been described to be involved in the tested outcome.
reports mention a variable prevalence of PP, ranging from 82.9 to 10.6%. These variations are because of the differences in study methods, and treatment procedures after root canal treatment, selection of patients or experience and skills of the dentists, vary when different studies are compared.
Read more
Many studies had confirmed that chemomechanical debridement of the root canal results in extrusion of dentinal chips, pulp tissue fragments, necrotic tissues, microorganisms, and root canal irrigants through the apical foramen. All preparation techniques and instruments, regardless of maintaining shorter working length of the apical terminus have reported to be related with extrusion of infected debris, and some of them extruded less material and others extruded more.
Periapical inflammation and postoperative flare-ups may result from apical extrusion of debris that is also referred to as the "worm" of necrotic debris A common outcome of the studies examining the amount of apically extruded debris was that the techniques involving a push-pull filing motion usually produce a greater mass of apical debris than those have rotational action Files which has reciprocating and in-and-out filing motion, may act as a piston, extruding more debris and irrigants. While the file with continuous rotation motion like a screw conveyor improving transportation of dentinal chips and debris coronally.
In this study, investigators compare post-endodontic pain between these two systems. Mtwo ( continuous rotation system) with safe-sider (reciprocating system). Therefore, the aim of this study is Evaluation of post-endodontic pain after root canal treatment with two rotary systems: Mtwo \& safe-sider
- Conditions
- Pain, Postoperative
- Being tested
- mtwo rotary system, safe-sider rotary system, hand files
- Keywords
- Instrumentation, Post-operative pain, Root canal preparation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mtwo rotary systemProcedure or surgery
post-treatment pain after using mtwo rotary system
safe-sider rotary systemProcedure or surgery
post-treatment pain after using safe-sider rotary system
hand filesProcedure or surgery
post-treatment pain after using hand files
| Study group | Role | What they receive |
|---|---|---|
| Mtwo rotary system | Experimental | ( continuous rotation system) Receives: Procedure: mtwo rotary system |
| safe-sider rotary system | Experimental | (reciprocating system) Receives: Procedure: safe-sider rotary system |
| hand files | Experimental | k-files Receives: Procedure: hand files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Information regarding post-operation pain is gathered via a patient using questionnaire and is measured via the visual analogue scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionFeb 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zahedan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- eshaghali saberi, professor, Study chair, professor of endodontics department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644031
- Sponsor's protocol ID
- 7203
- Status last verified
- Dec 2015
- First submitted
- 13 Dec 2015
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-endodontic Pain After Root Canal Treatment With Two Rotary Systems : Mtwo & Safe-sider
- ClinicalTrials.gov ID
- NCT02644031
- Acronym / sponsor ID
- 7203
- Conditions
- Pain, Postoperative
- Keywords
- Instrumentation, Post-operative pain, Root canal preparation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Zahedan University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 31 Dec 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.
Post-endodontic pain (PP) still is major problem for endodontic patients, analgesics are routinely prescribed. Incidence of PP is reported extensively, and reviewed. PP is a complicated multi factorial process and is affected by factors related to patients, to the tooth and to the skills and experience of the dentist and because of that, if the interrelation of these factors is not considered in a PP, study data might be confusing. Any study trying to evaluate the effect of a specific technique or new device in the incidence or characteristics of PP should control all the confounding factors that have been described to be involved in the tested outcome.
reports mention a variable prevalence of PP, ranging from 82.9 to 10.6%. These variations are because of the differences in study methods, and treatment procedures after root canal treatment, selection of patients or experience and skills of the dentists, vary when different studies are compared.
Many studies had confirmed that chemomechanical debridement of the root canal results in extrusion of dentinal chips, pulp tissue fragments, necrotic tissues, microorganisms, and root canal irrigants through the apical foramen. All preparation techniques and instruments, regardless of maintaining shorter working length of the apical terminus have reported to be related with extrusion of infected debris, and some of them extruded less material and others extruded more.
Periapical inflammation and postoperative flare-ups may result from apical extrusion of debris that is also referred to as the "worm" of necrotic debris A common outcome of the studies examining the amount of apically extruded debris was that the techniques involving a push-pull filing motion usually produce a greater mass of apical debris than those have rotational action Files which has reciprocating and in-and-out filing motion, may act as a piston, extruding more debris and irrigants. While the file with continuous rotation motion like a screw conveyor improving transportation of dentinal chips and debris coronally.
In this study, investigators compare post-endodontic pain between these two systems. Mtwo ( continuous rotation system) with safe-sider (reciprocating system). Therefore, the aim of this study is Evaluation of post-endodontic pain after root canal treatment with two rotary systems: Mtwo \& safe-sider
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mtwo rotary system | Experimental | Procedure: mtwo rotary system( continuous rotation system) |
| safe-sider rotary system | Experimental | Procedure: safe-sider rotary system(reciprocating system) |
| hand files | Experimental | Procedure: hand filesk-files |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range 20-50 years
- the systemically healthy
- first or second molar teeth require root canal therapy
- irreversible Pulpitis signed without the apical
- root canal curvature of less than 25 degrees, according to Schneider techniques
Key exclusion criteria (13 listed)
- Root canal treatment,
- history of medication (antibiotics, NSAID, opiates) of the patient 12 hours before treatment ,
- pregnancy,
- complex anatomy,
- channels blocked in the x-ray plate,
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 |
|---|---|---|
| mtwo rotary systempost-treatment pain after using mtwo rotary system | Procedure or surgery | Mtwo rotary system |
| safe-sider rotary systempost-treatment pain after using safe-sider rotary system | Procedure or surgery | safe-sider rotary system |
| hand filespost-treatment pain after using hand files | Procedure or surgery | hand files |
Primary outcome
Information regarding post-operation pain is gathered via a patient using questionnaire and is measured via the visual analogue scale.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
- Individual participant dataSharing planned: Undecided
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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.
eshaghali saberi, professor study chair
professor of endodontics department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mtwo rotary system, safe-sider rotary system and hand files in people with Pain, Postoperative, 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 5 inclusion and 13 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 31 Dec 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact arezoo hooshmandi, postgraduate (00989177089315, hooshmandi_arezoo@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Information regarding post-operation pain is gathered via a patient using questionnaire and is measured via the visual analogue scale. (time frame: 6 months). 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 31 Dec 2015.