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Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems

Primary Purpose

Pulpitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Reciproc
One Shape
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis focused on measuring Reciproc, One Shape, reciprocation, continuous rotation, irreversible pulpitis, postoperative pain

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Single-rooted mandibular premolar teeth with:

  • Preoperative sharp pain.
  • Vital response of pulp tissue.
  • Normal periapical radiographic appearance or slight widening in lamina dura.

Exclusion Criteria:

i. Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment.

ii. Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment.

iii. Pregnant females. iv. Patients having significant systemic disorder. v. If antibiotics have been administrated during the past two weeks preoperatively.

vi. Patients having bruxism or clenching. vii. Teeth that have:

  • Non vital pulp tissues.
  • Association with swelling or fistulous tract.
  • Pocket depth greater than 5 mm.
  • Previous endodontic treatment.

Sites / Locations

  • Endodontic Department - Faculty of Oral and Dental Medicine - Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reciproc

One Shape

Arm Description

Reciproc (VDW, Munich, Germany) is a single file reciprocating system for mechanical instrumentation of root canals. Size: R40 (40/0.06)

One Shape (MicroMega, Besançon Cedex, France) is a single file system that works by continuous rotation for mechanical instrumentation of root canals. Size: 25/0.06

Outcomes

Primary Outcome Measures

postoperative pain
Intensity of pain after endodontic treatment by Numerical Rating Scale (0-10)

Secondary Outcome Measures

Number of analgesic tablets taken after endodontic treatment
One tablet 400 mg Ibuprofen if patient experiences severe pain after treatment

Full Information

First Posted
October 18, 2016
Last Updated
July 25, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02940704
Brief Title
Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems
Official Title
Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial (Part I)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
January 2018 (Actual)

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
The aim of this study is to assess the postoperative pain and the intake of analgesic medication after using Reciproc single-file reciprocating system or One Shape single-file continuous rotary system in patients with symptomatic irreversible pulpitis. Patients will be diagnosed to determine whether they are eligible for the inclusion criteria of this study or not. Patients who are eligible will then start their root canal treatment on the same visit and to be completed in one visit only. Patients will be phone called in order to record the intensity of pain, amount and frequency of analgesic intake at 6, 12, 24, 48 and 72 hours after treatment.
Detailed Description
- Full medical and dental history using a schematic dental chart will be obtained from all eligible participants. Each tooth will be evaluated for vitality (sensitivity) of pulp tissues. The patients will be randomly divided into 2 groups: Experimental group: Reciproc reciprocating instrumentation system. Control group: One Shape rotary instrumentation system. - Sequence of Procedural steps Preoperative pain will be assessed by Numerical Rating Scale (NRS) before administration of anesthesia. Local anesthesia will be achieved using 2% lidocaine (1:100,000 adrenaline). An access cavity will be performed using round bur and Endo-Z bur. The tooth will be properly isolated with rubber dam. Working length will be determined using an electronic apex locator, and working length will be confirmed by 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) is to be used. Control group: Coronal preflaring will be performed using Gates Glidden drill. Canals will be instrumented using One Shape (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. 8.The rotary files will be introduced inside the canal using EDTA gel. 9.Canals will be irrigated with 2.5% 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 5 ml disposable plastic syringe placed as far as possible in the canal space without binding. 10.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. 11.The tooth will be sealed by temporary restoration, and postoperative pain will be assessed immediately after the end of treatment. 12.The patient will be instructed to return to complete the treatment procedures until placing a full-coverage restoration. 13.The patient will be instructed to take one tablet 400 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
Keywords
Reciproc, One Shape, reciprocation, continuous rotation, irreversible pulpitis, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reciproc
Arm Type
Experimental
Arm Description
Reciproc (VDW, Munich, Germany) is a single file reciprocating system for mechanical instrumentation of root canals. Size: R40 (40/0.06)
Arm Title
One Shape
Arm Type
Active Comparator
Arm Description
One Shape (MicroMega, Besançon Cedex, France) is a single file system that works by continuous rotation for mechanical instrumentation of root canals. Size: 25/0.06
Intervention Type
Procedure
Intervention Name(s)
Reciproc
Intervention Description
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) is to be used.
Intervention Type
Procedure
Intervention Name(s)
One Shape
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative pain
Description
Intensity of pain after endodontic treatment by Numerical Rating Scale (0-10)
Time Frame
Up to 72 hrs after treatment
Secondary Outcome Measure Information:
Title
Number of analgesic tablets taken after endodontic treatment
Description
One tablet 400 mg Ibuprofen if patient experiences severe pain after treatment
Time Frame
up to 72 hours after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Single-rooted mandibular premolar teeth with: Preoperative sharp pain. Vital response of pulp tissue. Normal periapical radiographic appearance or slight widening in lamina dura. Exclusion Criteria: i. Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment. ii. Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment. iii. Pregnant females. iv. Patients having significant systemic disorder. v. If antibiotics have been administrated during the past two weeks preoperatively. vi. Patients having bruxism or clenching. vii. Teeth that have: Non vital pulp tissues. Association with swelling or fistulous tract. Pocket depth greater than 5 mm. Previous endodontic treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel K Elias, Resident
Organizational Affiliation
Faculty of Oral and Dental Medicine - Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hebatallah M El-Far, Professor
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, Lecturer
Organizational Affiliation
Faculty of Oral and Dental Medicine - Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Endodontic Department - Faculty of Oral and Dental Medicine - Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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26843876
Citation
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Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems

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