Clinical trial NCT02940782: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pulpitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 54
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.
8. The rotary files will be introduced inside the canal using EDTA gel.
9. 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.
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 phone called for follow up after 6, 12, 24, 48 and 72 hours.
13. The patient will be instructed to return to complete the treatment procedures until placing a full-coverage restoration.
14. The patient will be instructed to take one tablet 600 mg Ibuprofen if he/she experiences severe pain.

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.

Primary outcomes:
measure: Assessment of the change in postoperative pain measured by the Numerical Rating Scale (0-10)
timeFrame: Immediately after treatment, then 6 hours, 12 hours, 24 hours and 72 hours after treatment.
Secondary outcomes:
measure: Number of analgesics taken by the patient
timeFrame: 72 hours from the end of the endodontic treatment
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Oral and Dental Medicine, Cairo University
name: Ahmed A Soliman, B.D.S
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Oral and Dental Medicine, Cairo University
name: Angie G Ghoneim
role: STUDY_DIRECTOR
affiliation: Faculty of Oral and Dental Medicine, Cairo University
name: Shaimaa I Gawdat
role: STUDY_CHAIR
References:
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.
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.