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

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ClinicalTrials.gov Identifier: NCT05904184
Recruitment Status : Completed
First Posted : June 15, 2023
Last Update Posted : June 15, 2023
Sponsor:
Information provided by (Responsible Party):
Tran Ngoc Minh Duyen, University of Medicine and Pharmacy at Ho Chi Minh City

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
Pulpitis - Irreversible Pain, Postoperative Drug: Epoxy resin-based sealers (ERS) Drug: Calcium silicate-based sealers (CSS) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of the Clinical Effectiveness of Calcium Silicate-based Sealer and Epoxy Resin-based Sealer in Single-visit Root Canal Treatment
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arms and Interventions
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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 Name: 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 Name: Epoxy resin-based cement


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05904184


Locations
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Vietnam
University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Vietnam, 72700
Sponsors and Collaborators
University of Medicine and Pharmacy at Ho Chi Minh City
More Information
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Publications:

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Responsible Party: Tran Ngoc Minh Duyen, University Post Graduated Student, University of Medicine and Pharmacy at Ho Chi Minh City
ClinicalTrials.gov Identifier: NCT05904184    
Other Study ID Numbers: 452/HD-DHYD
First Posted: June 15, 2023    Key Record Dates
Last Update Posted: June 15, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Tran Ngoc Minh Duyen, University of Medicine and Pharmacy at Ho Chi Minh City:
Calcium silicate-based sealer
Epoxy resin-based sealer
Additional relevant MeSH terms:
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Pulpitis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Dental Pulp Diseases
 Tooth Diseases
Stomatognathic Diseases
Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents