Pain Reduction Using Two Cold Irrigating Protocols in Teeth With Vital Pulps.
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The goal of this clinical research was to relate the incidence of post-endodontic pain after
      one-visit root canal treatment using two cold protocols of irrigation. Methodology: All 240
      patients had upper or lower molar, premolar or anterior teeth selected for conventional root
      canal treatment for prosthetic reasons detected with only vital pulps (symptomatic or
      asymptomatic condition). Of the sample of 240 teeth, were selected to different manner to
      irrigate. Reciproc instruments were used with a micro motor (VDW, Munich Germany). Final
      irrigation with cold (6oC, 2.5 oC and room temperature 17% EDTA and saline solution served as
      a lubricants.
    

Detailed description: 
      RCT was done in one-visit. Topical anesthetic (Anestesia Topica, Astra Mexico) was applied
      before infiltration. Patients received 2 carpules of articaine 2% with epinephrine 1:200,000
      (Septodont, Saint-Maur des-Fosses, France). In circumstances in which additional anesthesia
      was required, intra-ligamental anesthesia (2 mL articaine 2%) was administered. For the upper
      teeth, the solution was injected by slow and gradual local infiltration. For the lower teeth,
      1 of the carpules was used for an inferior alveolar nerve block and the other 1 for a gentle
      labial infiltration near the tooth to be treated.

      Rubber dam was placed and the tooth was clean with 5.25% NaOCl. Preparation of the access
      cavity was achieved using sterile # 331 bur (Dentsply Int, York, PA), with high-speed and
      refrigeration. 5.25% NaOCl was employed to disinfect the coronal access. The canals were
      cautiously probed with #10 K-type file (Flex-R files, Moyco/Union Broach, York PA, USA).

      17% EDTA (Roth International, Chicago, IL) irrigant was administered at the entrance of the
      canals. Working length was established with a #15 k-file and the Root ZX electronic apex
      locator (J Morita, Irvine CA, USA), and confirmed radiographically (Schick Technologies, NY,
      USA). Cervical and middle thirds of the canal was flared with a K3XF 25/10 rotary instrument
      (Kerr Endo, Orange County, CA) at 500 rpm. The root canal was flushed with 3 mL 5.25% sodium
      hypochlorite (NaOCl). A glide path to the WL was then established.

      Preparations of the canals were completed with an electric motor (VDW Silver Motor, VDW,
      Munich Germany). Torque and rotation were predetermined for each reciproc instrument, and
      were used in continuous reciprocating mode.

      Dentinal remains were removed from the instrument with a sterile gauze, immediately to the
      instrument change after two-three pull in-and-pull out (pecking) movements (Reciproc)
      following the manufacturers' recommendations.

      Each root canal was flushed with 2.5mL 2.6% NaOCl. Irrigation was achieved using a 24-gauge
      needle (Max-I-Probe; Tulsa Dental, York, PA) and a 31-G NaviTip needle (Ultradent Products
      Inc, South Jordan, UT) when getting the WL after each instrument insertion. A size #10 K file
      was used to maintain WL after each Reciproc instrument. The established WL was checked
      repeatedly throughout the clinical procedures.

      After instrumentation, the root canals were flushed with 1 mL 2.6% NaOCl, activated
      ultrasonically; It was achieved by means of an Irrisafe ultrasonic 20.00 tip (Satelec,
      Merignac, France) at 50% power of the Mini-Endo ultrasonic device (Kerr Endo) with the tip
      placed three mm from the WL for thirty seconds per root canal.

      Irrigating Protocols Group A. The R25 (size 25/ .08) instrument was used in thin and curved
      canals, and R40 files (40/ .06) were used in broad root canals. Three in/out pecking cycles
      were employed with a fullness of not more than 3 mm until reaching the established WL.
      Patients assigned to this group receive a final irrigation with 5 mL cold (6 oC) 17% EDTA
      followed with 20 mL cold (6 oC) sterile saline solution dispensed to the WL using a cold (6
      oC) metallic micro-cannula included in the Endo Vac System (Kerr Endo) for 5 minutes.

      Group B. Canals were prepared as in group A, Patients assigned to this group receive a final
      irrigation with 5 mL cold (2.5 oC) 17% EDTA followed with 20 mL cold (2.5 oC) sterile saline
      solution dispensed to the WL using a cold (2.5 oC) metallic micro-cannula included in the
      Endo Vac System for five minutes.

      Control Group (CG). The R25 (size 25/ .08) instrument was used in thin and curved root
      canals, and R40 files (40/ .06) were used in wide root canals. Three in-and-out cycles were
      applied with a distance of not more than three mm until getting the established WL. Reciproc
      instruments were employed in one tooth only (single use). Patients assigned to this control
      group were treated identically to the experimental groups, except that receive a final flush
      with 5 mL (room temperature) 17% EDTA followed with twenty mL (room temperature) sterile
      saline solution delivered to the WL using a metallic micro-cannula included in the Endo Vac
      System for five minutes.

      Each experimental and control group were flushed with the irrigant described above. Care was
      taken to confirm that the metallic cannula would aspirate properly by noticing the system's
      translucent evacuation duct. In case there was some obstacle, the metallic device was rapidly
      replaced.

      Recapitulation of working length was performed again by using an apex locator as described
      before using #35 and #40 files.

      The root canals were desiccated with disinfected paper cones and filled at the same visit.
      Gutta-percha points (Dentsply Maillefer) were laterally condensed with #25 nickel-titanium
      spreaders (Dentsply Maillefer) and AH-plus as the sealer (Dentsply Maillefer). The access
      cavities were etched and fixed with Fuji IX (GC Corp, Tokyo, Japan).

      After these irrigation regimens, the patients were warned of the possible occurrence of pain
      for hours following RCT and received an evaluation form (VAS questionnaire) to be completed
      and give it back 72 hours after. In it, they confirmed the presence/absence of pain. The pain
      level was measured using a validated pain scale known as the VAS (Hawker et al. 2011). The
      VAS scale is a continuous measure comprised of a horizontal line, which is 10 cm in length.
      For pain intensity, the VAS is anchored by ''no pain'' (score of 0) and ''pain as bad as it
      could be'' (score of 10). The cut points on the pain VAS are no pain (0-0.5 cm), mild pain
      (0.6-4.0 cm), moderate pain (0.45-7.4 cm), and severe pain (7.5-10 cm) (Jensen et al. 2003).
      The pain VAS was completed by the patients. The patients were asked to put a mark
      perpendicular to the pain VAS line at the point that indicated their pain severity during the
      3 days after the endodontic treatment.

      234 of the two hundred and forty examinations were properly returned. 77 belonged to the
      group A, 78 to group B and 79 to the Control group. The missing 6 questionnaires were
      returned one day later and were incorporated in the examination.

      The outcomes for the groups A, B and CG related to existence (yes/no), kind (mild, moderate,
      severe), and period (days) of pain were evaluated, and related to the following diagnostic
      factors: vital teeth, presence or absence of pre-operative pain, group of teeth, or
      ubication, age and sex, presence of occlusal contacts.
    

Intervention name(s): For the Group A. Applied Cryotherapy at 6 oC; For the Group B. Applied Cryotherapy at 2.5 oC; Control Group (CG). Applied irrigant at room temperature
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Patients assigned to this group receive a final irrigation with 5 mL cold (6 oC) 17% EDTA followed with 20 mL cold (6 oC) sterile saline solution dispensed to the WL using a cold (6 oC) metallic micro-cannula included in the Endo Vac System (Kerr Endo) for 5 minutes.; Patients assigned to this group receive a final irrigation with 5 mL cold (2.5 oC) 17% EDTA followed with 20 mL cold (2.5 oC) sterile saline solution dispensed to the WL using a cold (2.5 oC) metallic micro-cannula included in the Endo Vac System for five minutes.; Patients assigned to this control group were treated identically to the experimental groups, except that receive a final flush with 5 mL (room temperature) 17% EDTA followed with twenty mL (room temperature) sterile saline solution delivered to the WL using a metallic micro-cannula included in the Endo Vac System for five minutes.
Other intervention name(s): Cold irrigant used after root canal treatment; Cold irrigant used after RCT; Use of Saline solution at room temperature
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Random Selection of different temperature of irrigating solution groups. Of the sample of 240 teeth, 80 were randomly assigned to the one of the 3 irrigating protocols. Treatment was performed by 3 experienced endodontists; each prepared and irrigated 80 teeth.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: post-endodontic pain; pain; criotherapy; cold irrigation