Effect of EDDY and Manual Dynamic Activation Techniques on Postoperative Pain in Retreatment
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      The aim of the study was to evaluate the effectiveness of EDDY and manual dynamic activation
      (MDA) techniques on postoperative pain (PP) associated in retreatment. Ninety patients
      scheduled for retreatment were treated at one visit. After the single visit retreatment
      procedure, the patients were divided into two groups (n = 45) on the basis of the need for
      additional irrigation activation procedures (EDDY and MDA). The patients' post-treatment pain
      levels were asked to rate the intensity of their pain on a 10-point numerical rating scale
      (NRS) at 12th, 24th, 48th, and 72th hours and 7 days.
    

Detailed description: 
      The sample size was based on pilot study data that indicated that 38 patients would be
      sufficient for each group (type I alpha error = 5%, effect size = 0.7, power = 80%). To
      compensate for possible dropouts during the treatment and/or follow-up periods, 45 patients
      were assigned to each group.The study protocol was approved by the Ankara Yıldırım Beyazıt
      University Ethical Board of Clinical Trials and Non-interventional Research (2019-549).The
      inclusion criteria were as follows:

        1. Healthy individuals aged 18 to 40 years.

        2. Devital mandibular premolar teeth with asymptomatic periapical lesions.

        3. Teeth with initial root canals filled 2-4 mm short of the apex.

        4. Premolar teeth with periapical radiolucency (PAI 3-4) [12] detected by radiographic
           examination.

        5. Coronal restoration.

        6. Teeth on which root canal treatment had been performed in the researcher's hospital at
           least 4 years prior to the study.

      The exclusion criteria were as follows:

        1. The use of drugs, such as analgesics, anti-inflammatories, and antibiotics, for pain and
           infection control in the previous 12 hours.

        2. A history of susceptibility or adverse reactions to any drugs or materials used in the
           study.

        3. Teeth with open apexes and resorption.

        4. Teeth with post-core restoration.

        5. Vertical root fractures and teeth on which surgery had been performed.

        6. Pregnancy and breastfeeding. A participant voluntary consent form was obtained from each
           patient. Ninety patients were numerically coded in computer environment by someone who
           was not included in the study for randomization (www.random.org)A single clinician
           performed retreatment on each of the 90 teeth during a single visit. A 27-gauge dental
           injector (Set Inject; Set Medical Instruments, Istanbul, Turkey) was used to anesthetize
           the patients with a solution of 40 mg Articain and 0.006 mg/mL epinephrine (Ultracain DS
           Forte; Aventis, Istanbul, Turkey). Old restorations and caries were removed, and on the
           basis of the straight-line principle, round diamond burs were used to create access
           cavities under rubber dam isolation. All subsequent treatment procedures were performed
           under rubber dam isolation, and 3.5× (Zumax Sle Loupe) magnification was used. When
           necessary, the cervical margin was elevated with composite resin to ensure the
           continuity of the isolation.

      The gutta-percha and sealer were removed with hand files and ProTaper retreatment (Dentsply
      Maillefer) files. No solvent was used. The working length was calculated with a ProPex Pixi
      apex locater (Dentsply Maillefer). Periapical radiography allowed for the calculation of the
      working length and confirmation of the removal of the previous canal filling. Root canals
      were enlarged to be ProTaper Universal F3 (30/0.9). A lubricant (Glyde File Prep, Dentsply
      DeTrey, GmbH, Konstanz, Germany) was used between each file to prevent the rotary files from
      getting stuck in the root canal. A total of 20 mL 2.5% sodium hypochlorite (NaOCl) irrigation
      solution (Werax, Izmir, Turkey) was used for each treatment. For all teeth, the final
      irrigation was performed with 5 mL 17% ethylenediaminetetraacetic acid (EDTA) solution
      (Werax, Izmir, Turkey) for 1 minute. After the retreatment procedure, the patients were
      divided into two groups on the basis of the additional irrigation activation procedures with
      6 mL 2.5% NaOCl (n = 45). Information on which irrigation activation methods to use was not
      given to the patient.

      First group (manual dynamic activation): A final rinse with 6 mL 2.5% NaOCl was done
      performed after shaping, using a ProTaper Universal F3 (Dentsply, Maillefer, Ballaigues,
      Switzerland) gutta-percha up and down movements to as 1 mm short from the working length for
      1 minute.

      Second group (EDDY): A 28 mm long polyamide tip with 25.04 taper was adapted to TA-200
      (Micron, Tokyo, Japan) and operated at 6,000 Hz, the maximum speed setting. It was placed in
      the canal 2 mm shorter than the working length. Next, 6 mL 2.5% NaOCl was administered to the
      canal in three 20-second activation-nonactivation cycles (2 ml/20 seconds).

      The root canals were dried with paper points (Dentsply, Sirona). The working length was
      reached with ProTaper Universal F3 gutta-percha (Dentsply, Sirona), and tug-back was taken.
      The gutta-percha was covered with a sealer (AH Plus; Dentsply, Sirona), and root canal
      fillings were performed with a single-cone technique. After the completion of the root canal
      filling procedures, the residual materials were removed with a heat source. A resin composite
      (3M, ESPE) was used for the coronal restorations. Occlusal reduction was performed on all the
      teeth included in the study. No antibiotics or analgesics were prescribed.

      Patient questionnaire The postoperative follow-up and evaluation of the cases were performed
      by a researcher who had no knowledge of the study group. A 10-point numerical rating scale
      (NRS) was introduced to the patients, and they were asked to rate their post-treatment pain
      by telephone after 12, 24, 48, and 72 hours. The antibiotics and analgesics were questioned.
      The patients were called for clinical examination 1 week later. Palpation and percussion
      sensitivity in the treated teeth was determined on the basis of the patients' perceptions of
      pain. All percussion tests were performed by the same operator to ensure standardization. The
      measurement values were based on the 10-point NRS. The pain scores were placed into the
      following four categories: 0 = none, 1-3 = mild, 4-6 = moderate, and 7-10 = severe.
    

Intervention name(s): Evaluation of postoperative pain
Intervention type(s): Other
Intervention description(s): A participant voluntary consent form was obtained from each patient. Ninety patients were numerically coded in computer environment by someone who was not included in the study for randomization (www.random.org).
A single clinician performed retreatment on each of the 90 teeth during a single visit.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients referred to the endodontic clinic for retreatment were asked to complete a
        questionnaire to provide pre-treatment clinical conditions and demographic data.
        participant voluntary consent form was obtained from each patient. Ninety patients were
        numerically coded in computer environment by someone who was not included in the study for
        randomization (www.random.org).