Completed

Comparison of the Clinical Effectiveness of Calcium Silicate-based Sealer and Epoxy Resin-based Sealer in Single-visit Root Canal Treatment

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What is being tested

Epoxy resin-based sealers (ERS)

+ Calcium silicate-based sealers (CSS)

Drug
Who is being recruted

Neurologic Manifestations+4

+ Pain

+ Pain, Postoperative

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2020
See protocol details

Summary

Principal SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2020

Actual date on which the first participant was enrolled.

Background: Sealers have been concerned with obturation. However, studies for assessing the effectiveness of endodontic treatment of sealer based on Calcium Silicate have been not much. Objective: This study aimed to assess the effectiveness of endodontic treatment of sealer based on Calcium Silicate Methods: A prospective, single-blind, clinical trial was conducted from June 2020 to December 2020 with 42 irreversible pulpitis teeth by one clinician. The postoperative pain was assessed after root canal treatment using sealer based on Calcium Silicate and sealer based on Epoxy resin after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days and inconvenient symptoms were assessed after 7 days, 3 months and 6 months. t-test, Mann-Whitney and Wilcoxon analysis were applied. Key words: obturation, sealer based on Calcium Silicate and sealer based on Epoxy resin

Official TitleComparison of the Clinical Effectiveness of Calcium Silicate-based Sealer and Epoxy Resin-based Sealer in Single-visit Root Canal Treatment
NCT05904184
Principal SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

42 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

Inclusion Criteria: * aged 18 years or older * teeth diagnosed with irreversible pulpitis by electrical and thermal tests (+) * had clinical symptoms like continuous or spontaneous pain, teeth exposed to sudden temperature changes, especially cold stimuli, causing sharp pain and persisting after stimulus removal * these teeth must have healthy periodontal tissue and sufficient clinical teeth crown for isolation with a rubber dam Exclusion criteria: Patients with: * Pregnant * Have a systemic disease requiring antibiotics or have an allergic reaction * Have maxillofacial pathology, cellulitis, occlusal trauma, and temporomandibular disorders, have endodontic periodontal lesions, periodontal abscesses * Have taken a previous pain reliever within 24 hours Tooth: * Roots internally or externally resorbed, cracked or broken * Have had failed endodontic treatment, or the root canal cannot be controlled for leakage * No opposing teeth

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
After root canal preparation, canal obturation was performed with Calcium silicate-based sealers (CSS)

Group II

Active Comparator
After root canal preparation, canal obturation was performed with Epoxy resin-based sealers (ERS)

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, VietnamOpen University of Medicine and Pharmacy at Ho Chi Minh City in Google Maps
CompletedOne Study Center