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Comparison Between Reciproc and Oneshape Systems

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02940782
Collaborator
(none)
54
Enrollment
2
Arms
11
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Reciproc single file system
  • Procedure: One Shape single file system
  • Device: X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland
 N/A

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:

  1. Assessment of preoperative pain by NRS before administration of anesthesia.

  2. Administration of local anesthesia using 2% lidocaine (1:100,000 adrenaline).

  3. An access cavity will be done using a round bur and Endo-Z bur.

  4. Isolation of the affected tooth with rubber dam.

  5. 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.

  6. Canals will be explored with hand K-file ISO sizes 10, 15, 20.

  7. 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.

  1. The rotary files will be introduced inside the canal using EDTA gel.

  2. 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.

  3. 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.

  4. The tooth will be sealed by temporary restoration, and postoperative pain will be assessed immediately after the end of treatment.

  5. The patient will be phone called for follow up after 6, 12, 24, 48 and 72 hours.

  6. The patient will be instructed to return to complete the treatment procedures until placing a full-coverage restoration.

  7. The patient will be instructed to take one tablet 600 mg Ibuprofen if he/she experiences severe pain.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Oct 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Reciproc single file system

It is a reciprocating NiTi file used for instrumentation of root canals in endodontic treatment

Procedure: Reciproc single file system
A reciprocating Nickel Titanium single file system used for instrumentation of root canals in endodontic treatment.

Device: X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland
It is a micro-motor designed for performing root canal treatments with the reciprocating, single file technique or traditional continuous rotation file system.
Active Comparator: One Shape single file system

It is a rotary NiTi file used for instrumentation of root canals in endodontic treatment

Procedure: One Shape single file system
A rotary Nickel Titanium single file system used for instrumentation of root canals in endodontic treatment.

Device: X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland
It is a micro-motor designed for performing root canal treatments with the reciprocating, single file technique or traditional continuous rotation file system.

Outcome Measures

Primary Outcome Measures

  1. Assessment of the change in postoperative pain measured by the Numerical Rating Scale (0-10) [Immediately after treatment, then 6 hours, 12 hours, 24 hours and 72 hours after treatment.]

    Pain intensity after root canal treatment will be measured using Numerical Rating Scale (0-10)

Secondary Outcome Measures

  1. Number of analgesics taken by the patient [72 hours from the end of the endodontic treatment]

    It will be recorded by the patient with time intervals

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Ahmed A Soliman, B.D.S, Faculty of Oral and Dental Medicine, Cairo University
  • Study Director: Angie G Ghoneim, Faculty of Oral and Dental Medicine, Cairo University
  • Study Chair: Shaimaa I Gawdat, Faculty of Oral and Dental Medicine, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmed Adel Abdullah Ali Soliman, Masters Candidate, Cairo University
ClinicalTrials.gov Identifier:
NCT02940782
Other Study ID Numbers:
  • reciproc_oneshape
First Posted:
Oct 21, 2016
Last Update Posted:
Oct 21, 2016
Last Verified:
Oct 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Pulpitis

Study Results

No Results Posted as of Oct 21, 2016