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

Phase 3
Completed
Conditions
Pain, Postoperative
Pulpitis - Irreversible
Interventions
Drug: Epoxy resin-based sealers (ERS)
Registration Number
NCT05904184
Lead Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
42
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
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Epoxy resin-based sealers (ERS)Calcium silicate-based sealers (CSS)After root canal preparation, canal obturation was performed with Epoxy resin-based sealers (ERS)
calcium silicate-based sealers (CSS)Epoxy resin-based sealers (ERS)After root canal preparation, canal obturation was performed with Calcium silicate-based sealers (CSS)
Primary Outcome Measures
NameTimeMethod
Change in treatment outcome evaluation over time1 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

Change in pain intensity over timeafter 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.

Change in pain relief over timeafter 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Medicine and Pharmacy at Ho Chi Minh City

🇻🇳

Ho Chi Minh City, Vietnam

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