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

NCT05816772 | Completed Early Phase 1 DMC

• 1 other identifier: HShaharyar
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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:

1. 1.To compare pre and postoperative pain within each group(calcium hydroxide sealer and Bioceramic sealer).
2. 2.Compare postoperative pain between calcium hydroxide sealer and Bioceramic sealer groups.
3. 3.To observe the effect of type of tooth and patient demographics on postoperative pain in each group.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (5)

• 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)

  Before application of experimental agents (Day 0)

• 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.

  24 hour after 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.

  48 hour after 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.

  72 hour after 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.

  7 Days after application of experimental agents

Study Arms (2)

Endosequence Bio ceramic based Sealer

EXPERIMENTAL

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.

Drug: Endosequence Bio ceramic Sealer

Sealapex calcium hydroxide based sealer

ACTIVE COMPARATOR

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.

Drug: Sealapex Calcium hydroxide Based Sealer

Interventions

Endosequence Bio ceramic Sealer DRUG

Brasseler,USA, a nano-particulate injectable premixed bioceramic sealer that contains Calcium Silicates, Calcium Phosphate, Calcium Hydroxide and Zirconium Oxide

Endosequence Bio ceramic based Sealer

Sealapex Calcium hydroxide Based Sealer DRUG

KERR Dental, an original eugenol-free root canal sealant based on calcium hydroxide.

Sealapex calcium hydroxide based sealer

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow International Dental College (Defence campus)

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Syed Hasan Shaharyar, BDS

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: October 25, 2022
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)