Comparison Between Reciproc and Oneshape Systems
Primary Purpose
Pulpitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reciproc single file system
One Shape single file system
X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland
Sponsored by
About this trial
This is an interventional treatment trial for Pulpitis
Eligibility Criteria
Inclusion Criteria:
Mandibular premolar teeth with:
- Single canal
- Preoperative sharp pain.
- Vital response of pulp tissue.
- Normal periapical radiographic appearance or slight widening in lamina dura.
- Final diagnosis for an eligible patient will take place by radiograph and pulp testing.
Exclusion Criteria:
- Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment.
- Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment.
- Pregnant females.
- Patients having significant systemic disorder.
- If antibiotics have been administrated during the past two weeks preoperatively.
- Patients having bruxism or clenching.
Teeth that have:
- Non-vital pulp tissues.
- Association with swelling or fistulous tract.
- A pocket depth greater than 5 mm.
- Previous endodontic treatment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Reciproc single file system
One Shape single file system
Arm Description
It is a reciprocating NiTi file used for instrumentation of root canals in endodontic treatment
It is a rotary NiTi file used for instrumentation of root canals in endodontic treatment
Outcomes
Primary Outcome Measures
Assessment of the change in postoperative pain measured by the Numerical Rating Scale (0-10)
Pain intensity after root canal treatment will be measured using Numerical Rating Scale (0-10)
Secondary Outcome Measures
Number of analgesics taken by the patient
It will be recorded by the patient with time intervals
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02940782
Brief Title
Comparison Between Reciproc and Oneshape Systems
Official Title
Assessment of Postoperative Pain After Using Reciroc Versus One Shape NiTi Systems in Patients With Symptomatic Irreversible Pulpitis (A Randomized Clinical Trial): Part Two
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized clinical trial to assess postoperative pain in patients with symptomatic irreversible pulpitis after using Reciproc versus One Shape rotary NiTi Systems.
Detailed Description
The study aims at comparing postoperative pain after using two single-file NiTi systems, Reciproc reciprocating system and One Shape rotary system, for root canal instrumentation in patients with symptomatic irreversible pulpitis.
After the patient is found eligible, he/she will be randomly assigned to either the control (One Shape) or experimental group (Reciproc) and will be treated in a single visit.
Sequence of Procedural Steps:
Assessment of preoperative pain by NRS before administration of anesthesia.
Administration of local anesthesia using 2% lidocaine (1:100,000 adrenaline).
An access cavity will be done using a round bur and Endo-Z bur.
Isolation of the affected tooth with rubber dam.
Determination of the working length using an electronic apex locator, and confirmed by a radiograph using K-file. Then, the working length will be established at 0.5 mm up to the radiographic apex.
Canals will be explored with hand K-file ISO sizes 10, 15, 20.
Mechanical preparation for both groups will be as follows:
Experimental group:
Canals will be instrumented using Reciproc reciprocating system set on an electric motor, with adjusted torque and speed according to the manufacturer's instructions.
There is no need for coronal preflaring with a Gates Glidden drill or an orifice opener since the design of the Reciproc instrument allows any obstructions in the coronal third to be removed, as claimed by the manufacturer.
Reciproc file selection: R40 (40/0.06)
Control group:
Coronal preflaring will be performed using Gates Glidden drill.
Canals will be instrumented using One Shape single-file (25/0.06) set on an electric motor with adjusted torque and speed according to the manufacturer's instructions.
For wide canals, One Shape Apical (30/0.06, 37/0.06) will be used.
The rotary files will be introduced inside the canal using EDTA gel.
Canals will be irrigated with 2.6% sodium hypochlorite solution between every subsequent instrument. It is prepared by adding 10 ml of sterile distilled water to 10 ml of 5.25% sodium hypochlorite solution using a 27 gauge needle fit to 5ml disposable plastic syringe placed in the canal space without binding.
Canals will be dried with sterile paper points and obturated using lateral condensation technique. A spreader will be used to allow space for auxiliary cones, with resin-based root canal sealer.
The tooth will be sealed by temporary restoration, and postoperative pain will be assessed immediately after the end of treatment.
The patient will be phone called for follow up after 6, 12, 24, 48 and 72 hours.
The patient will be instructed to return to complete the treatment procedures until placing a full-coverage restoration.
The patient will be instructed to take one tablet 600 mg Ibuprofen if he/she experiences severe pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reciproc single file system
Arm Type
Experimental
Arm Description
It is a reciprocating NiTi file used for instrumentation of root canals in endodontic treatment
Arm Title
One Shape single file system
Arm Type
Active Comparator
Arm Description
It is a rotary NiTi file used for instrumentation of root canals in endodontic treatment
Intervention Type
Procedure
Intervention Name(s)
Reciproc single file system
Intervention Description
A reciprocating Nickel Titanium single file system used for instrumentation of root canals in endodontic treatment.
Intervention Type
Procedure
Intervention Name(s)
One Shape single file system
Intervention Description
A rotary Nickel Titanium single file system used for instrumentation of root canals in endodontic treatment.
Intervention Type
Device
Intervention Name(s)
X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland
Intervention Description
It is a micro-motor designed for performing root canal treatments with the reciprocating, single file technique or traditional continuous rotation file system.
Primary Outcome Measure Information:
Title
Assessment of the change in postoperative pain measured by the Numerical Rating Scale (0-10)
Description
Pain intensity after root canal treatment will be measured using Numerical Rating Scale (0-10)
Time Frame
Immediately after treatment, then 6 hours, 12 hours, 24 hours and 72 hours after treatment.
Secondary Outcome Measure Information:
Title
Number of analgesics taken by the patient
Description
It will be recorded by the patient with time intervals
Time Frame
72 hours from the end of the endodontic treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mandibular premolar teeth with:
Single canal
Preoperative sharp pain.
Vital response of pulp tissue.
Normal periapical radiographic appearance or slight widening in lamina dura.
Final diagnosis for an eligible patient will take place by radiograph and pulp testing.
Exclusion Criteria:
Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment.
Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment.
Pregnant females.
Patients having significant systemic disorder.
If antibiotics have been administrated during the past two weeks preoperatively.
Patients having bruxism or clenching.
Teeth that have:
Non-vital pulp tissues.
Association with swelling or fistulous tract.
A pocket depth greater than 5 mm.
Previous endodontic treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Soliman, B.D.S
Phone
+20-01003564036
Email
aasoliman89@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Soliman, B.D.S
Organizational Affiliation
Faculty of Oral and Dental Medicine, Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angie G Ghoneim
Organizational Affiliation
Faculty of Oral and Dental Medicine, Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shaimaa I Gawdat
Organizational Affiliation
Faculty of Oral and Dental Medicine, Cairo University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25773449
Citation
Neelakantan P, Sharma S. Pain after single-visit root canal treatment with two single-file systems based on different kinematics--a prospective randomized multicenter clinical study. Clin Oral Investig. 2015 Dec;19(9):2211-7. doi: 10.1007/s00784-015-1448-x. Epub 2015 Mar 15.
Results Reference
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PubMed Identifier
26614017
Citation
Kherlakian D, Cunha RS, Ehrhardt IC, Zuolo ML, Kishen A, da Silveira Bueno CE. Comparison of the Incidence of Postoperative Pain after Using 2 Reciprocating Systems and a Continuous Rotary System: A Prospective Randomized Clinical Trial. J Endod. 2016 Feb;42(2):171-6. doi: 10.1016/j.joen.2015.10.011. Epub 2015 Nov 29.
Results Reference
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Comparison Between Reciproc and Oneshape Systems
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