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Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Early Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Endosequence Bio ceramic Sealer
Sealapex Calcium hydroxide Based Sealer
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients who need root canal treatment of minimum one tooth. Patients between 18 years to 60 years of age. Single rooted tooth with a single (type I canal configuration according to vertucci) canal including mandibular and maxillary incisors, canine and premolars except maxillary first premolar. Tooth is diagnosed with symptomatic Irreversible Pulpitis. The periapical index score is from 2 to 3 according to Orstavik et al. Exclusion Criteria: • Medically compromised patients. Patient rejecting to participate in study. Inability to achieve the full length of canal. Teeth with periodontal disease (probing depth >4mm). Complication during treatment (separation of file, ledge formation, etc.). Pulpal necrosis, chronic apical periodontitis, acute and chronic periodontal abcess. Any swelling or draining sinus.

Sites / Locations

  • Dow International Dental College (Defence campus)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endosequence Bio ceramic based Sealer

Sealapex calcium hydroxide based sealer

Arm Description

Sealer was introduced into the canal by coating the master gutta-percha point (Endosequence, Brasseler USA, Gutta Percha ) with sealer, followed by cold lateral compaction using a finger spreader # 30 and # 35 (Saybron Endo) with decreasing working length by 1-2 mm. A heated plugger was used to sear off GuttaPercha coronal to canal orifice.Recordings of postoperative pain was obtained at 24 hours, 48 hours, 72 hours and 7 days after obturation with aid of the Visual Analogue Scale.

Sealer was introduced into the canal by coating the master gutta-percha point (Dentsply Sirona, GuttaPercha Conform fit) with sealer, followed by cold lateral compaction using a finger spreader # 30 and # 35 (Saybron Endo) with decreasing working length by 1-2 mm. A heated plugger was used to sear off GuttaPercha coronal to canal orifice.Recordings of postoperative pain was obtained at 24 hours, 48 hours, 72 hours and 7 days after obturation with aid of the Visual Analogue Scale.

Outcomes

Primary Outcome Measures

Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at Day 0 before the application of experimental agents. Visual Analog Scale which will be scored as 0 (No Pain), 1-3 (Mild Pain), 4-6 (Moderate pain) and 7-10 ( Severe pain)
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 24 hour after the application of experimental agents.
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 48 hour after the application of experimental agents.
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 72 hour after the application of experimental agents.
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 7 Days after the application of experimental agents.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2023
Last Updated
April 4, 2023
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05816772
Brief Title
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Official Title
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment: A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
April 3, 2023 (Actual)
Study Completion Date
April 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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: To compare pre and postoperative pain within each group(calcium hydroxide sealer and Bioceramic sealer). Compare postoperative pain between calcium hydroxide sealer and Bioceramic sealer groups. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endosequence Bio ceramic based Sealer
Arm Type
Experimental
Arm Description
Sealer was introduced into the canal by coating the master gutta-percha point (Endosequence, Brasseler USA, Gutta Percha ) with sealer, followed by cold lateral compaction using a finger spreader # 30 and # 35 (Saybron Endo) with decreasing working length by 1-2 mm. A heated plugger was used to sear off GuttaPercha coronal to canal orifice.Recordings of postoperative pain was obtained at 24 hours, 48 hours, 72 hours and 7 days after obturation with aid of the Visual Analogue Scale.
Arm Title
Sealapex calcium hydroxide based sealer
Arm Type
Active Comparator
Arm Description
Sealer was introduced into the canal by coating the master gutta-percha point (Dentsply Sirona, GuttaPercha Conform fit) with sealer, followed by cold lateral compaction using a finger spreader # 30 and # 35 (Saybron Endo) with decreasing working length by 1-2 mm. A heated plugger was used to sear off GuttaPercha coronal to canal orifice.Recordings of postoperative pain was obtained at 24 hours, 48 hours, 72 hours and 7 days after obturation with aid of the Visual Analogue Scale.
Intervention Type
Drug
Intervention Name(s)
Endosequence Bio ceramic Sealer
Intervention Description
Brasseler,USA, a nano-particulate injectable premixed bioceramic sealer that contains Calcium Silicates, Calcium Phosphate, Calcium Hydroxide and Zirconium Oxide
Intervention Type
Drug
Intervention Name(s)
Sealapex Calcium hydroxide Based Sealer
Intervention Description
KERR Dental, an original eugenol-free root canal sealant based on calcium hydroxide.
Primary Outcome Measure Information:
Title
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Description
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at Day 0 before the application of experimental agents. Visual Analog Scale which will be scored as 0 (No Pain), 1-3 (Mild Pain), 4-6 (Moderate pain) and 7-10 ( Severe pain)
Time Frame
Before application of experimental agents (Day 0)
Title
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Description
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 24 hour after the application of experimental agents.
Time Frame
24 hour after application of experimental agents
Title
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Description
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 48 hour after the application of experimental agents.
Time Frame
48 hour after application of experimental agents
Title
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Description
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 72 hour after the application of experimental agents.
Time Frame
72 hour after application of experimental agents
Title
Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.
Description
Comparison of postoperative pain assessed with the help of Visual Analog Scale(VAS). Recording was obtained at 7 Days after the application of experimental agents.
Time Frame
7 Days after application of experimental agents

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who need root canal treatment of minimum one tooth. Patients between 18 years to 60 years of age. Single rooted tooth with a single (type I canal configuration according to vertucci) canal including mandibular and maxillary incisors, canine and premolars except maxillary first premolar. Tooth is diagnosed with symptomatic Irreversible Pulpitis. The periapical index score is from 2 to 3 according to Orstavik et al. Exclusion Criteria: • Medically compromised patients. Patient rejecting to participate in study. Inability to achieve the full length of canal. Teeth with periodontal disease (probing depth >4mm). Complication during treatment (separation of file, ledge formation, etc.). Pulpal necrosis, chronic apical periodontitis, acute and chronic periodontal abcess. Any swelling or draining sinus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Hasan Shaharyar, BDS
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dow International Dental College (Defence campus)
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Post-Operative Pain After Use of Calcium Hydroxide and Bio Ceramic Sealer for Root Canal Treatment.

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