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

Study Overview
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Brief Summary
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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 Title
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Comparison of the Clinical Effectiveness of Calcium Silicate-based Sealer and Epoxy Resin-based Sealer in Single-visit Root Canal Treatment

Conditions
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Pulpitis - Irreversible, Pain, Postoperative

Intervention / Treatment
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* Drug: Epoxy resin-based sealers (ERS)
* Drug: Calcium silicate-based sealers (CSS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epoxy resin-based sealers (ERS)<br>After root canal preparation, canal obturation was performed with Epoxy resin-based sealers (ERS) | Drug: Calcium silicate-based sealers (CSS)<br>* 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.<br>* Other names: Calcium silicate-based cement;|
| Active Comparator: calcium silicate-based sealers (CSS)<br>After root canal preparation, canal obturation was performed with Calcium silicate-based sealers (CSS) | Drug: Epoxy resin-based sealers (ERS)<br>* 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.<br>* Other names: Epoxy resin-based cement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity over time | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcium silicate-based sealer, Epoxy resin-based sealer