Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Background:

      Root canal therapy is a well documented and established method to eliminate inflamed pulp and
      reduce pain, but the procedure itself is associated with postoperative discomfort, ranging
      from 1.2%-82.9% in different studies. There are several treatment-related factors that are
      found to be linked to postoperative pain, including gauging canal length with apex locator,
      the choice of instrumentation, number of visits and the root canal sealer being used. When
      used in the root canal obturation, an endodontic sealer may affect periodontal tissue through
      apical foramina, lateral canals, or leaching and can hinder the healing process. Thus, the
      local inflammation caused by root canal obturation may result in post-operative pain. The
      extent of inflammatory response depends on multiple factors, which also include the content
      of the sealer.

      The reason of using calcium hydroxide sealers is driven by their potential for tissue healing
      and antibacterial properties. Antimicrobial effects of Calcium Hydroxide is attributed to the
      presences and numbers of hydroxyl groups which cause pH to increase as high as 12.5.

      The elevated pH levels also encourage repair and bone ossification, thus helping in healing.
      Hard tissue formation which is associated with calcium hydroxide's alkaline nature occurs due
      to inhibition of lactic acid secreted by osteoclast, activation of Alkaline phosphatase and
      calcium-dependent ATP.

      Bioceramic sealers are considered to provide better results for root canals treatments by
      promoting osteoblastic differentiation and by releasing bioactive substances. Cytotoxicity of
      bioceramics is lower in comparision of resin-based sealers. Less cytotoxicity also lowers the
      potential of irritation and inflammation of periodontal tissues, thus leading to reduced
      levels of associated post-operative pain. Very limited data is available on the comparison
      between calcium hydroxide and bioceramic sealer.

      Objectives:

        1. To compare pre and postoperative pain within each group(calcium hydroxide sealer and
           Bioceramic sealer).

        2. Compare postoperative pain between calcium hydroxide sealer and Bioceramic sealer
           groups.

        3. To observe the effect of type of tooth and patient demographics on postoperative pain in
           each group.

      Methods:

      After taking consent, A total of 80 patients with symptomatic irreversible pulpitis will be
      randomly assigned to one of two groups in this 6-month In-Vitro Single-Blinded Randomized
      Clinical Study. Group A will receive calcium hydroxide as an endodontic sealer and B will
      receive bioceramic sealer respectively. Recordings of postoperative pain will be obtained at
      24 hours, 48 hours, 72 hours and 7 days after obturation with aid of the Visual Analogue
      Scale by the Researcher.

      SPSSv.24 will be used to analyze the data with the level of significance set at p < 0.05. For
      comparison of VAS scores, Paired Sample t-test//Wilcoxon-signed rank test will be used.
      Independent sample-test/Mann-Whitney U-test will be used to assess the differences in VAS
      pain scores between the groups. The chi-square test will be used to determine the frequency
      of tooth types among the tested materials and the distribution of patients among VAS scores.
    


Intervention name(s): Endosequence Bio ceramic Sealer; Sealapex Calcium hydroxide Based Sealer
Intervention type(s): Drug; Drug
Intervention description(s): Brasseler,USA, a nano-particulate injectable premixed bioceramic sealer that contains Calcium Silicates, Calcium Phosphate, Calcium Hydroxide and Zirconium Oxide; KERR Dental, an original eugenol-free root canal sealant based on calcium hydroxide.
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention