Comparative Evaluation of Post Endodontic Pain Following Root Canal Treatment With Two Rotary System: Neolix & Waveone
Primary Purpose
Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
neolix rotary system (continuous rotation system)
waveone rotary system (reciprocating system)
hand files k-files
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms focused on measuring Instrumentation Post-operative pain Root canal preparation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- open apex teeth,
- periodontal disease,
- inflammation and abscesses,
- sinus tract,
- presence of radiographic lesions,
- tooth sensitivity to percussion,
- absence of occlusal contact.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
neolix rotary system (continuous rotation system)
waveone rotary system (reciprocating system)
hand files k-files
Arm Description
Procedure: neolix rotary system post-treatment pain after using neolix rotary system
Procedure: waveone rotary system post-treatment pain after using waveone rotary system
Procedure: hand files post-treatment pain after using hand files
Outcomes
Primary Outcome Measures
Information regarding post-operation pain is gathered via a patient using questionnaire and is measured via the visual analogue scale
Secondary Outcome Measures
Full Information
NCT ID
NCT02768311
First Posted
May 9, 2016
Last Updated
May 10, 2016
Sponsor
Zahedan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02768311
Brief Title
Comparative Evaluation of Post Endodontic Pain Following Root Canal Treatment With Two Rotary System: Neolix & Waveone
Official Title
Comparative Evaluation of Post Endodontic Pain Following Root Canal Treatment With Two Rotary System: Neolix & Waveone
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zahedan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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:
1) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms
Keywords
Instrumentation Post-operative pain Root canal preparation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
neolix rotary system (continuous rotation system)
Arm Type
Experimental
Arm Description
Procedure: neolix rotary system post-treatment pain after using neolix rotary system
Arm Title
waveone rotary system (reciprocating system)
Arm Type
Experimental
Arm Description
Procedure: waveone rotary system post-treatment pain after using waveone rotary system
Arm Title
hand files k-files
Arm Type
Experimental
Arm Description
Procedure: hand files post-treatment pain after using hand files
Intervention Type
Procedure
Intervention Name(s)
neolix rotary system (continuous rotation system)
Intervention Description
Procedure: neolix rotary system
Intervention Type
Procedure
Intervention Name(s)
waveone rotary system (reciprocating system)
Intervention Description
Procedure: waveone rotary system
Intervention Type
Procedure
Intervention Name(s)
hand files k-files
Intervention Description
Procedure: hand files k-files
Primary Outcome Measure Information:
Title
Information regarding post-operation pain is gathered via a patient using questionnaire and is measured via the visual analogue scale
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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,
open apex teeth,
periodontal disease,
inflammation and abscesses,
sinus tract,
presence of radiographic lesions,
tooth sensitivity to percussion,
absence of occlusal contact.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Comparative Evaluation of Post Endodontic Pain Following Root Canal Treatment With Two Rotary System: Neolix & Waveone
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