Comparison of Calcium Silicate-based Sealer and Epoxy Resin-based Sealer

June 6, 2023 updated by: Tran Ngoc Minh Duyen, University of Medicine and Pharmacy at Ho Chi Minh City

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 72700
        • University of Medicine and Pharmacy at Ho Chi Minh City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Epoxy resin-based sealers (ERS)
After root canal preparation, canal obturation was performed with Epoxy resin-based sealers (ERS)
Drug: Calcium silicate-based sealers (CSS)
All teeth received one-visit endodontic treatment according to the treatment protocol of the Vietnamese Ministry of Health with the support of three-dimensional imaging equipment and an endodontic machine. After root canal preparation, obturation was performed using Calcium silicate-based sealers.
Other Names:
  • Calcium silicate-based cement
Active Comparator: calcium silicate-based sealers (CSS)
After root canal preparation, canal obturation was performed with Calcium silicate-based sealers (CSS)
Drug: Epoxy resin-based sealers (ERS)
All teeth received one-visit endodontic treatment according to the treatment protocol of the Vietnamese Ministry of Health with the support of three-dimensional imaging equipment and an endodontic machine. After root canal preparation, obturation was performed using Epoxy resin-based sealers.
Other Names:
  • Epoxy resin-based cement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity over time
Time Frame: after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment
The investigator instructed patients on how to use the 170-mm Heft-Parker self-assessment scale to evaluate their pain intensity. Swelling, fistula, and sensitivity under biting pressure were classified as binary variables.
after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment
Change in pain relief over time
Time Frame: after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment
The investigator instructed patients on how to use the 170-mm Heft-Parker self-assessment scale to evaluate their pain intensity. Swelling, fistula, and sensitivity under biting pressure were classified as binary variables.
after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment
Change in treatment outcome evaluation over time
Time Frame: 1 week, 3 months and 6 months after treatment
Based on Strindberg's criteria of clinical symptoms, the treatment outcome evaluation was then expressed as success, failure, or uncertain depending on the presence of symptoms
1 week, 3 months and 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 452/HD-DHYD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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