Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Status:
Completed
Trial end date:
2023-04-03
Target enrollment:
Participant gender:
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.