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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05904184
Enrollment
42
Registered
2023-06-15
Start date
2020-06-01
Completion date
2021-12-31
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Pulpitis - Irreversible

Keywords

Calcium silicate-based sealer, Epoxy resin-based sealer

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

Interventions

DRUGEpoxy 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.

DRUGCalcium 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.

Sponsors

University of Medicine and Pharmacy at Ho Chi Minh City
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pain intensity over timeafter 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after treatmentThe 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.
Change in pain relief over timeafter 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after treatmentThe 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.
Change in treatment outcome evaluation over time1 week, 3 months and 6 months after treatmentBased 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

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026