Post-endodontic Pain After Single-visit Root Canal Treatment
Condition: Relate Post-endodontic Pain
Study type: Interventional

Summary: 
      The goal of this research was to relate the occurrence of post-endodontic pain after
      single-visit RCT using Balanced Force technique and three reciprocating system when AP is
      conserved. Methodology: All 224 patients had upper or lower molar, premolar or anterior teeth
      selected for conventional RCT for prosthetic reasons detected with only vital pulps. Of the
      sample of 224 teeth, 56 were selected to the 4 instrumentation methods. For hand
      instrumentation, Balanced Force were used. All canals were clean and shaped with hand Flex-R
      files (fMoyco/Union Broach, York PA, USA). For mechanical shaping, all instruments were used
      with a micro motor (VDW, Munich Germany). Twisted files adaptive, WaveOne and Reciproc
      instruments. Final irrigation with cold (6oC) 17% EDTA served as a lubricant.
    

Detailed description: 
      This clinical research took place at the University Autonomous of Baja California, School of
      Dentistry, Tijuana, Mexico. The subjects review committee accepted the research, and
      conducted in accordance with ethical principles (including the World Medical Association
      Declaration of Helsinki).

      The principal inclusion parameters were absence of radiographic sign of apical periodontitis
      and a diagnosis of irreversible pulpitis (IP) established by affirmative response to hot and
      cold examinations.

      Thermal pulp examination was achieved by the corresponding author, and radiographic analysis
      was established by 3 certified endodontists. Clinical requirements were established on the
      next conditions: 1) The purposes and necessities of the research were spontaneously accepted.
      2) Clinical Management was pointed to patients in physical and mental well-being. 3) All
      teeth had vital pulps and absence of apical periodontitis. 4) Positive thermal stimulation
      with EndoIce (Hygenic Corp, Akron, OH). 5) Teeth with enough coronal structure for rubber dam
      isolation. 6) No RCT done before the research. 7) No painkillers or antibiotics used 7 days'
      prior the clinical events started.

      Exclusion parameters were the necessity for retreatment, gravidity, impossibility to obtain
      patient's approval, patients who didn't complete inclusion necessities, a history of
      medication for chronic pain or those compromising the immune response, patients younger than
      18 years and the existence of mishaps or difficulties during RCT (calcified canals,
      impracticality of achieving AP in any canal).

      Patient selection Two hundred and twenty four of 245 patients (126 women and 98 men) aged
      18-65 years were incorporated in this research (Fig. 1). Sample size estimate was achieved
      according with a method for this specific purpose (Cochran's method, 1986). Therefore, the 56
      teeth allocated to each group were adequate to confirm an essential sample.

      Random Selection of instrumentation groups. Of the sample of 224 teeth, 56 were selected to
      the 4 instrumentation methods. The study strategy included 3 experts; each expert prepared 56
      teeth, 14 per technique.

      Treatment Protocol The standard method involved the following steps: Access was gotten; REDTA
      (Roth International, Chicago, IL) lubricant was located at the entry of the canals.
      Determination of WL was first determined with a #15 k-file and the Root ZX electronic device
      (J Morita, Irvine CA, USA), following by subtracting 0.5 mm from the measurement, which was
      calculated with the assistance of a metallic ruler. With digital radiographic confirmation
      (Schick Technologies, NY, USA). A glide path to the WL was then established.

      For hand instrumentation, Balanced Force were used. All canals were clean and shaped with
      hand Flex-R files (fMoyco/Union Broach, York PA, USA). Gates-Glidden burs (Dentsply
      Maillefer) sizes #2 and #3 were used at the entry of the canals. For mechanical shaping, all
      instruments were used with a micro motor (VDW Silver Reciproc Motor). Torque and rotation
      were established independently for each instrument method used. Twisted file adaptive,
      WaveOne and Reciproc instruments were used in continuous brushing rotary motion and
      reciprocating mode respectively.

      Group TFA. SM1 (size 20, .04 taper) and SM2 (size 25, .06 taper) files were used serially
      with a single controlled motion according to the manufacturer's instructions.

      Group BF. For the Balanced force group, the root canals were cleaned and shaped using a #40
      instrument for thin or curved canals and a #55 file for widespread canals.

      Group WON. For the WaveOne group, a file (25.08) was used to prepare narrow, straight and
      curved canals, and a file (40.08) was used for large and wide canals.

      Three in-and-out motions were used with lengths not beyond 3 mm in the three thirds of the
      canal until reaching the estimated WL.

      Group REC. R25 (25.08) instrument was used in thin and curved RC, and R40 files (40.06) were
      used in wide canals. Three in-and-out motions were used with lengths not beyond 3 mm in the
      three thirds of the canal until reaching the estimated WL.

      Hand and rotary files were employed in just 1 tooth (single use) and then excluded. AP was
      conserved through all the procedures used by using a #10 K-type file at WL.

      After instrumentation phase, pulp chamber was rinsed with 1 mL 2.6% NaOCl, agitated
      ultrasonically. Ultrasonic activation was performed using an Irrisafe ultrasonic 20.00 tip
      (Satelec, M erignac, France) at 50% power of the MiniEndo ultrasonic unit (Kerr Endo) to
      place the tip 3 mm from the WL for 30 seconds per canal. Then, each experimental group
      received a final irrigation with cold (6oC) 17% EDTA gently delivered to the WL using a cold
      (6oC) sterile metallic micro cannula attached to the Endovac negative pressure irrigation
      system (Kerr Endo) for three minutes to eliminate the smear layer and reduce post-endodontic
      pain. Caution was taken to ensure that the micro cannula would suction correctly by detecting
      the system's transparent evacuation tube. In case there was any obstruction, the micro
      cannula was instantly substituted.

      Repeat of WL was established again by using EAL as describe before using #35, #40 and # 45
      files.

      The root canals were then desiccated with disinfected paper cones and filled at the same
      visit. Gutta-percha cones (Dentsply Maillefer) were laterally compacted with #20
      nickel-titanium spreaders (Dentsply Maillefer) and AH-plus sealer (Dentsply Maillefer).
      Entrance openings of anterior teeth were etched and repaired with Fuji IX (GC Corp, Tokyo,
      Japan). For posterior teeth, a rebuilding was placed with the same method.

      Assessment of Post-endodontic pain and Statistical Analysis Patients were informed of the
      probable incidence of pain for days following RCT and received a survey form to be finished
      and returned three days after. In it, they proof the occurrence or nonappearance of
      post-endodontic pain, its period and level of distress rated as follows: mild pain: any
      discomfort of any duration that does not require treatment; moderate pain: pain that requires
      and is relieved with analgesics; and severe pain: any pain that is not calmed with treatment
      (analgesics).

      Outcomes were examined with the Chi-Square for the occurrence of post-endodontic pain, and
      Mann-Whitney U test.
    

Intervention name(s): Twisted File Adaptive; Balance Force; WaveOne; Reciproc technique
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Twisted file adaptive SM1 (size 20, .04 taper) and SM2 (size 25, .06 taper) were used serially with a single controlled motion according to the manufacturer's instructions.; Flex-R files sizes 15-45 taper .02 were used according to the technique; WaveOne instrument was used to prepare narrow, straight and curved canals, and file (40.08) was used for large canals.
Three in-and-out motions were used with lengths not beyond 3 mm in the three thirds of the canal until reaching the estimated WL.; Reciproc files were used in wide canals. Three in-and-out motions were used with lengths not beyond 3 mm in the three thirds of the canal until reaching the estimated WL.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: teeth selected for conventional RCT for prosthetic reasons detected with only vital pulps. Of the sample of 224 teeth, 56 were selected to the 4 instrumentation methods. For hand instrumentation, Balanced Force were used. All canals were clean and shaped with hand Flex-R files (fMoyco/Union Broach, York PA, USA). For mechanical shaping, all instruments were used with a micro motor (VDW, Munich Germany). Twisted files adaptive, WaveOne and Reciproc instruments. Final irrigation with cold (6oC) 17% EDTA served as a lubricant.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: post -endodontic pain; endodontic pain; pain