The Effect of Two Different Root Canal Sealers on Postobturation Pain and Clinical and Radiographical Outcome After Two-year Follow-up
Condition: Asymptomatic Vital Mandibular Molar Teeth
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      Post-obturation pain evaluation(Part 1):

      One hundred asymptomatic mandibular molar teeth with vital pulp were randomly assigned into
      two groups according to the sealer used MTA Fillapex (Angelus Odontologica Industries SA,
      Londrina, PR, Brazil) or AH Plus (Dentsply Sirona, Ballaigues, Switzerland) sealer. WaveOne
      Gold instruments were used for root canal preparations in both groups. Root canals were
      obturated with the manufacturer advised own gutta-percha points of preparation technique and
      MTA Fillapex was used in the first group and AH Plus was used in the second group as a root
      canal sealer. Postoperative pain at 6, 12, 24, 48, 72 hours, 4, 5, 6, 7, and 30 days after
      root canal treatment was measured with the Numerical Rating Scale (NRS), and patients were
      informed to record the number of analgesics they used during these time periods.

      Clinical and radiological outcome evaluation(Part 2):

      Patients were recalled for clinical and radiographic examinations at 12 and 24 months
      postoperatively. The clinical outcome was determined as success or failure according to
      objective evaluation of symptoms of inflammation or infection. In clinical examination at
      follow-up appointments, swelling, pain, sinus tract, tenderness to percussion, and/or
      palpation test, periodontal probing depths were determined and recorded. The radiographic
      outcome was evaluated and classified according to the Strindberg criteria. Teeth with a
      normal contour, width, and structure of the periodontal ligament were considered
      as"successful" and teeth with a widened periodontal contours or a new periapical radiolucency
      were considered as "failed". Additionally, the other parameters (age, gender, tooth number,
      apical gutta level) on treatment success were examined.
    

Detailed description: 
      This randomized clinical trial aimed to evaluate and compare the effect of MTA-based
      bioceramic and resin-based sealers on the incidence and intensity of post-obturation pain and
      clinical and radiological outcome after two-year follow-up in asymptomatic vital molar teeth
      in single-visit root canal treatment. One hundred asymptomatic mandibular molar teeth with
      vital pulp were randomly assigned into two groups according to the sealer used MTA Fillapex
      (Angelus Odontologica Industries SA, Londrina, PR, Brazil) or AH Plus (Dentsply Sirona,
      Ballaigues, Switzerland) sealer. WaveOne Gold instruments were used for root canal
      preparations in both groups. Root canals were obturated with the manufacturer advised own
      gutta-percha points of preparation technique and MTA Fillapex was used in the first group and
      AH Plus was used in the second group as a root canal sealer.

      Post-obturation pain evaluation(Part 1):

      Postoperative pain at 6, 12, 24, 48, 72 hours, 4, 5, 6, 7, and 30 days after root canal
      treatment was measured with the Numerical Rating Scale, and patients were informed to record
      the number of analgesics they used during these time periods. The Mann-Whitney U test was
      used to compare the postoperative pain and the analgesic use between the two groups according
      to NRS scores. The relationship between the number of analgesics used and the total NRS
      values were analyzed by Spearman Correlation Analysis. Evaluation of NRS scores at all time
      points for each group was done by Friedman Two-Way Analysis of Variance Test.

      Clinical and radiological outcome evaluation(Part 2):

      Patients were recalled for clinical and radiographic examinations at 12 and 24 months
      postoperatively. The clinical outcome was determined as success or failure according to
      objective evaluation of symptoms of inflammation or infection. In clinical examination at
      follow-up appointments, swelling, pain, sinus tract, tenderness to percussion, and/or
      palpation test, periodontal probing depths were determined and recorded. The radiographic
      outcome was evaluated and classified according to the Strindberg criteria. Teeth with a
      normal contour, width, and structure of the periodontal ligament were considered as
      "successful" and teeth with a widened periodontal contours or a new periapical radiolucency
      were considered as"failed". Additionally, the other parameters (age, gender, tooth number,
      apical gutta level) on treatment success were examined. All of the pairwise comparisons
      between the groups at 1st and 2nd year were done by chi-square test (Fisher exact test).
      Pearson's chi-square test was used to evaluate the age, gender of the patients and tooth
      types between the groups
    

Intervention name(s): MTA Fillapex root canal sealer; AH Plus root canal sealer
Intervention type(s): Other; Other
Intervention description(s): Root canal treatments were performed with MTA Fillapex; Root canal treatments were performed with AH plus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: asymptomatic irreversible pulpitis; bioceramic sealer; post-obturation pain; resin-based sealer; treatment outcome