Effect Of Simultaneous Working Length Control Postoperative Pain
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
simultaneous working length control using E-CONNECT S
separate length determination and root canal preparation using Root ZX apex locator.
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Age between (20-50) years old with symptomatic irreversible pulpitis in permanent mandibular premolar teeth.
- Systemically- healthy patients (ASA I or II).
- Patients who agree to attend for recall appointments and provide written consent.
Exclusion Criteria:
- Pregnant women and patients with pacemakers.
- Patients with bruxism or clenching or have taken analgesics during past 24 hours.
- Moderate or severe marginal periodontitis (i.e. pocket probing >3 mm).
- Necrotic pulp, pulp polyp, tooth tender to percussion, preoperative palpation pain, clinical progression into periapical abscess, fistula.
- Teeth with internal or external resorption, curvatures, open apices, root canal obliteration, perforation, incomplete root formation, teeth previously undergone root canal treatment, absence of opposing tooth to the related tooth or radiographically invisible canals.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
simultaneous working length control
Root ZX apex locator.
Arm Description
• Using simultaneous working length control during root canal preparation using E-CONNECT S endomotor with integrated apex locator.
Using manual control of the working length by using stoppers during instrumentation (separate length determination and root canal preparation) using Root ZX apex locator.
Outcomes
Primary Outcome Measures
Postoperative pain after endodontic treatment
Intensity of postoperative pain will be measured using Visual Analogue scale (VAS) for pain assessment 7 days after the end of endodontic treatment. It uses numerical data:
None 0, Mild <20, Moderate 20-50 and Sever >50.
Secondary Outcome Measures
Number of analgesic tablets taken by the patient after endodontic treatment.
Number of analgesic tablets taken by the patient after endodontic treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03899129
Brief Title
Effect Of Simultaneous Working Length Control Postoperative Pain
Official Title
Effect Of Simultaneous Working Length Control During Root Canal Preparation Versus Electronic Apex Locator On Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis (a Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study was to evaluate the effect of simultaneous length control during root canal preparation on postoperative pain compared with separate working length determination and root canal preparation using electronic apex locator. During preparation of root canals, loss of working length (WL) can lead to instrumentation beyond the predefined apical limit of the preparation. This effect is mainly attributed to straightening of the root canal during instrumentation. Some studies showed, that this kind of over instrumentation as well as under instrumentation can adversely affect the outcome of the endodontic treatment, while it remains uncertain what exactly is the most favorable extent of the apical limit of root canal preparation. Furthermore, all endodontic instruments produce apical extrusion of debris, even when the preparation is kept within the confines of the root canal. Consequently, preparations ending in the periapical tissue will produce a greater amount of debris extrusion that could elicit a neurogenic inflammatory response resulting from an irritation of the periodontal ligament with subsequent postoperative symptomatic apical periodontitis. Therefore, it seems favorable to control the determined WL during root canal preparation to avoid preparations ending in the periapical tissue.
Detailed Description
During preparation of root canals, loss of working length (WL) can lead to instrumentation beyond the predefined apical limit of the preparation. This effect is mainly attributed to straightening of the root canal during instrumentation. Some studies showed, that this kind of over instrumentation as well as under instrumentation can adversely affect the outcome of the endodontic treatment. Furthermore, all endodontic instruments produce apical extrusion of debris, even when the preparation is kept within the confines of the root canal. Consequently, preparations ending in the periapical tissue will produce a greater amount of debris extrusion that could result from an irritation of the periodontal ligament with subsequent postoperative symptomatic apical periodontitis. Therefore, it seems favorable to control the determined WL during root canal preparation to avoid preparations ending in the periapical tissue.
Endodontic motors with integrated apex locators offer a solution to the described problem as they have been developed with the intention of making root canal treatment easier and faster. Besides torque and speed control, these devices also aim to continuously monitor and control the apical limit all the way through the mechanical preparation of the root canals and have an auto apical reverse (AAR) function that stops and reverse the rotation when the file tip reaches the predetermined apical limit of the preparation.
E-CONNECT S (Eighteeth medical technology Co., Ltd, china) is an endomotor with integrated apex locator newly introduced in the market with continuous WL measuring function. It contains an optional module for rotary instrumentation, allowing the device to function as a low-speed hand piece, apex locator, or a combination of both. This motor has an attention-grabbing property that when an instrument reaches the predetermined working length, the motor automatically stops the instrumentation. Thus, it can be concluded that automatically stopping instrumentation when the instrument reaches the working length would decrease postoperative pain compared with manually controlling the working length by using stoppers during instrumentation (separate length determination and root canal preparation).
The Root ZX (J Morita, Tokyo, Japan) is a third generation EAL where no calibration is necessitated, and a microprocessor analyzes the impedance quotient. It uses multiple frequencies to calculate the distance from the end of the canal. To measure location within the canal, third generation units (including Root ZX EAL) still use impedance measurements but have stronger microprocessors and can process the mathematical quotient and algorithm calculations required to obtain accurate readings. The change in electrical capacitance at the apical constriction is the basis for the operation of the Root ZX and its reported accuracy, even in presence of different electrolytes in the canal and under different clinical conditions; that's why it is considered the most commonly used apex locator.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
Masking
ParticipantOutcomes Assessor
Masking Description
The study will be participant-blind where the participants will not know the intervention done. The applications could not be blinded; however, the statistician will be blinded.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
simultaneous working length control
Arm Type
Experimental
Arm Description
• Using simultaneous working length control during root canal preparation using E-CONNECT S endomotor with integrated apex locator.
Arm Title
Root ZX apex locator.
Arm Type
Active Comparator
Arm Description
Using manual control of the working length by using stoppers during instrumentation (separate length determination and root canal preparation) using Root ZX apex locator.
Intervention Type
Procedure
Intervention Name(s)
simultaneous working length control using E-CONNECT S
Intervention Description
E-CONNECT S (Eighteeth medical technology Co., Ltd, china) is an endomotor with integrated apex locator newly introduced in the market with continuous WL measuring function. It contains an optional module for rotary instrumentation, allowing the device to function as a low-speed handpiece, apex locator, or a combination of both. This motor has an attention-grabbing property that when an instrument reaches the predetermined working length, the motor automatically stops the instrumentation. Thus, it can be concluded that automatically stopping instrumentation when the instrument reaches the working length would decrease postoperative pain compared with manually controlling the working length by using stoppers during instrumentation (separate length determination and root canal preparation).
Intervention Type
Procedure
Intervention Name(s)
separate length determination and root canal preparation using Root ZX apex locator.
Intervention Description
Using manual control of the working length by using stoppers during instrumentation (separate length determination and root canal preparation) using Root ZX apex locator.
Primary Outcome Measure Information:
Title
Postoperative pain after endodontic treatment
Description
Intensity of postoperative pain will be measured using Visual Analogue scale (VAS) for pain assessment 7 days after the end of endodontic treatment. It uses numerical data:
None 0, Mild <20, Moderate 20-50 and Sever >50.
Time Frame
7 days after root canal treatment.
Secondary Outcome Measure Information:
Title
Number of analgesic tablets taken by the patient after endodontic treatment.
Description
Number of analgesic tablets taken by the patient after endodontic treatment.
Time Frame
Until 7 days after endodontic treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between (20-50) years old with symptomatic irreversible pulpitis in permanent mandibular premolar teeth.
Systemically- healthy patients (ASA I or II).
Patients who agree to attend for recall appointments and provide written consent.
Exclusion Criteria:
Pregnant women and patients with pacemakers.
Patients with bruxism or clenching or have taken analgesics during past 24 hours.
Moderate or severe marginal periodontitis (i.e. pocket probing >3 mm).
Necrotic pulp, pulp polyp, tooth tender to percussion, preoperative palpation pain, clinical progression into periapical abscess, fistula.
Teeth with internal or external resorption, curvatures, open apices, root canal obliteration, perforation, incomplete root formation, teeth previously undergone root canal treatment, absence of opposing tooth to the related tooth or radiographically invisible canals.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aml M moteleb
Phone
20-01092359661
Email
aml.abdelmoteleb@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Heba elasfouri
Phone
20-01005276232
Email
Heba.elasfouri@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aml M moteleb
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available
IPD Sharing Time Frame
data will be available within 6 months from study completion
IPD Sharing Access Criteria
Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.
Learn more about this trial
Effect Of Simultaneous Working Length Control Postoperative Pain
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