Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and SymptomsNCT02768311
Comparative Evaluation of Post Endodontic Pain Following Root Canal Treatment With Two Rotary System: Neolix & Waveone
A study testing neolix rotary system (continuous rotation system), waveone rotary system (reciprocating system) and hand files k-files in people with Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms, run by Zahedan University of Medical Sciences.
Trial summary
Today, dentists tend to use rotary systems. Despite the increasing diversity of these systems as well as a few studies on the prevalence of pain after root canal treatment by rotary systems, And in particular, comparing the amount of pain after treatment, between systems RECIPROCAL AND FULL ROTATION single-file, the… 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 Pain Pathologic Processes Postoperative Complications Signs and Symptoms
- What is being tested?
- neolix rotary system (continuous rotation system), waveone rotary system (reciprocating system) and hand files k-files
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 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 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,
Show all 13Show fewer
- open apex teeth,
- periodontal disease,
- inflammation and abscesses,
- sinus tract,
- presence of radiographic lesions,
- tooth sensitivity to percussion,
- absence of occlusal contact.
About this study
Today, dentists tend to use rotary systems. Despite the increasing diversity of these systems as well as a few studies on the prevalence of pain after root canal treatment by rotary systems, And in particular, comparing the amount of pain after treatment, between systems RECIPROCAL AND FULL ROTATION single-file, the aim of this study was to evaluate the effect of applying canal preparation by the system, Neolix and WaveOne, on the prevalence of pain after endodontic treatments.
Read the detailed description
Many studies of pain after root canal treatment experience were taken into consideration.
Pain after endodontic treatment is still one of the major problems of patients. The prevalence that widely studied as 6/10% to 9.82% have been reported.
One of the important strategies in endodontic treatment, prevention and control of pain after treatment. This multi-factorial disorder resulting in a complex process occurs, which affects the patient's intrinsic factors, the tooth and the dentist's skill.
Mechanical factors include channel instrumentation techniques, over instrumentation or filling material extrusion channels associated with the presence of pain after treatment were considered.
Apical extrusion of infected debris during instrumentation channel can create or exacerbate inflammatory process. Channel shaping the apical debris extrusion process can increase even if the preparation is limited to the channel. Leaving debris in both methods of preparation, either manually with stainless steel files and rotary technique with nickel titanium files happen.
The use of rotary technique among dentists has increased. developing of NITI files and rotary instrumentation system, reduce apical extrusion of debris, so can be expected to reduce the incidence of inflammation and pain after treatment, achieved by these means.
Recent studies have shown that reciprocal shaping techniques, compared with full-rotation techniques, significantly increased the amount of debris extruded from the apical region of the root are causing increasing pain after treatment.
Two rotary system available on the market are:
- Neolix (france Neolix SAS) recently introduced the file NITI, single file, with full rotation movements, with square and rectangular cross-section, with a non-uniform shape along the blade, tip sizes, 25 and Tipper 0 / 08, and a system, Wave one, (DENTSPLY Maillefer), which is a file NITI, Single file and Single use, and the reciprocation movements, and cross-Convex triangular Modified and in three sizes: small, primary (tip size 25 and Tipper 0/08), large is contained, which according to the size of the canal, one of them is selected.
In a study by Ana Arias et al., Patients in the experimental group by the Rotary Files roots were treated and patients in control group were treated by the step-back technique, the results showed that more patients in the control group, experienced pain after root canal therapy. While the duration of the pain in the control group comparison to the experimental group, less has been reported.
In a study by Aqrabawi, teeth with vital pulp were divided into two groups. Root canal therapy in the first group, was done by manual file, and the second group, by Protaper rotary files were performed.
And no significant difference in pain after root canal treatment has not been detected.
Gambarini was shown in the study, patients treated by waveone system they have done, significantly more pain after treatment compared to TF and TF adaptive experienced.
Today, dentists tend to use rotary systems. Despite the increasing diversity of these systems as well as a few studies on the prevalence of pain after root canal treatment by rotary systems, And in particular, comparing the amount of pain after treatment, between systems RECIPROCAL AND FULL ROTATION single-file, the aim of this study was to evaluate the effect of applying canal preparation by the system, Neolix and WaveOne, on the prevalence of pain after endodontic treatments.
- Conditions
- Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms
- Being tested
- neolix rotary system (continuous rotation system), waveone rotary system (reciprocating system), hand files k-files
- Keywords
- Instrumentation Post-operative pain Root canal preparation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neolix rotary system (continuous rotation system)Procedure or surgery
Procedure: neolix rotary system
waveone rotary system (reciprocating system)Procedure or surgery
Procedure: waveone rotary system
hand files k-filesProcedure or surgery
Procedure: hand files k-files
| Study group | Role | What they receive |
|---|---|---|
| neolix rotary system (continuous rotation system) | Experimental | Procedure: neolix rotary system post-treatment pain after using neolix rotary system Receives: Procedure: neolix rotary system (continuous rotation system) |
| waveone rotary system (reciprocating system) | Experimental | Procedure: waveone rotary system post-treatment pain after using waveone rotary system Receives: Procedure: waveone rotary system (reciprocating system) |
| hand files k-files | Experimental | Procedure: hand files post-treatment pain after using hand files Receives: Procedure: hand files k-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: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and SymptomsStudies 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
- Double blind
- Who is masked
- Participant, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768311
- Sponsor's protocol ID
- 7354
- Status last verified
- Apr 2016
- First submitted
- 9 May 2016
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Post Endodontic Pain Following Root Canal Treatment With Two Rotary System: Neolix & Waveone
- ClinicalTrials.gov ID
- NCT02768311
- Acronym / sponsor ID
- 7354
- Conditions
- Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms
- 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
- May 2016
- Primary completion
- May 2017 (estimated)
- First posted
- 11 May 2016 (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.
Today, dentists tend to use rotary systems. Despite the increasing diversity of these systems as well as a few studies on the prevalence of pain after root canal treatment by rotary systems, And in particular, comparing the amount of pain after treatment, between systems RECIPROCAL AND FULL ROTATION single-file, the aim of this study was to evaluate the effect of applying canal preparation by the system, Neolix and WaveOne, on the prevalence of pain after endodontic treatments.
Detailed description
Many studies of pain after root canal treatment experience were taken into consideration.
Pain after endodontic treatment is still one of the major problems of patients. The prevalence that widely studied as 6/10% to 9.82% have been reported.
One of the important strategies in endodontic treatment, prevention and control of pain after treatment. This multi-factorial disorder resulting in a complex process occurs, which affects the patient's intrinsic factors, the tooth and the dentist's skill.
Mechanical factors include channel instrumentation techniques, over instrumentation or filling material extrusion channels associated with the presence of pain after treatment were considered.
Apical extrusion of infected debris during instrumentation channel can create or exacerbate inflammatory process. Channel shaping the apical debris extrusion process can increase even if the preparation is limited to the channel. Leaving debris in both methods of preparation, either manually with stainless steel files and rotary technique with nickel titanium files happen.
The use of rotary technique among dentists has increased. developing of NITI files and rotary instrumentation system, reduce apical extrusion of debris, so can be expected to reduce the incidence of inflammation and pain after treatment, achieved by these means.
Recent studies have shown that reciprocal shaping techniques, compared with full-rotation techniques, significantly increased the amount of debris extruded from the apical region of the root are causing increasing pain after treatment.
Two rotary system available on the market are:
- Neolix (france Neolix SAS) recently introduced the file NITI, single file, with full rotation movements, with square and rectangular cross-section, with a non-uniform shape along the blade, tip sizes, 25 and Tipper 0 / 08, and a system, Wave one, (DENTSPLY Maillefer), which is a file NITI, Single file and Single use, and the reciprocation movements, and cross-Convex triangular Modified and in three sizes: small, primary (tip size 25 and Tipper 0/08), large is contained, which according to the size of the canal, one of them is selected.
In a study by Ana Arias et al., Patients in the experimental group by the Rotary Files roots were treated and patients in control group were treated by the step-back technique, the results showed that more patients in the control group, experienced pain after root canal therapy. While the duration of the pain in the control group comparison to the experimental group, less has been reported.
In a study by Aqrabawi, teeth with vital pulp were divided into two groups. Root canal therapy in the first group, was done by manual file, and the second group, by Protaper rotary files were performed.
And no significant difference in pain after root canal treatment has not been detected.
Gambarini was shown in the study, patients treated by waveone system they have done, significantly more pain after treatment compared to TF and TF adaptive experienced.
Today, dentists tend to use rotary systems. Despite the increasing diversity of these systems as well as a few studies on the prevalence of pain after root canal treatment by rotary systems, And in particular, comparing the amount of pain after treatment, between systems RECIPROCAL AND FULL ROTATION single-file, the aim of this study was to evaluate the effect of applying canal preparation by the system, Neolix and WaveOne, on the prevalence of pain after endodontic treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| neolix rotary system (continuous rotation system) | Experimental | Procedure: neolix rotary system (continuous rotation system)Procedure: neolix rotary system post-treatment pain after using neolix rotary system |
| waveone rotary system (reciprocating system) | Experimental | Procedure: waveone rotary system (reciprocating system)Procedure: waveone rotary system post-treatment pain after using waveone rotary system |
| hand files k-files | Experimental | Procedure: hand files k-filesProcedure: hand files post-treatment pain after using hand 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 |
|---|---|---|
| neolix rotary system (continuous rotation system)Procedure: neolix rotary system | Procedure or surgery | neolix rotary system (continuous rotation system) |
| waveone rotary system (reciprocating system)Procedure: waveone rotary system | Procedure or surgery | waveone rotary system (reciprocating system) |
| hand files k-filesProcedure: hand files k-files | Procedure or surgery | hand files k-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: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Individual participant dataSharing planned: Yes
Related trials for Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Recruiting
Conditioned Open Label Placebo for Postoperative Pain Management
Pain, Postoperative
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 neolix rotary system (continuous rotation system), waveone rotary system (reciprocating system) and hand files k-files in people with Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms, run by Zahedan 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 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 11 May 2016. 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?
Results are not available in the source record.
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?
Information regarding post-operation pain is gathered via a patient using questionnaire and is measured via the visual analogue scale (time frame: 12 month). 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 11 May 2016.