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

Primary Purpose

Pulpitis - Irreversible, Pain, Postoperative

Status
Completed
Phase
Phase 3
Locations
Vietnam
Study Type
Interventional
Intervention
Epoxy resin-based sealers (ERS)
Calcium silicate-based sealers (CSS)
Sponsored by
University of Medicine and Pharmacy at Ho Chi Minh City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible focused on measuring Calcium silicate-based sealer, Epoxy resin-based sealer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Medicine and Pharmacy at Ho Chi Minh City

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Epoxy resin-based sealers (ERS)

calcium silicate-based sealers (CSS)

Arm Description

After root canal preparation, canal obturation was performed with Epoxy resin-based sealers (ERS)

After root canal preparation, canal obturation was performed with Calcium silicate-based sealers (CSS)

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
February 23, 2023
Last Updated
June 6, 2023
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
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1. Study Identification

Unique Protocol Identification Number
NCT05904184
Brief Title
Comparison of Calcium Silicate-based Sealer and Epoxy Resin-based Sealer
Official Title
Comparison of the Clinical Effectiveness of Calcium Silicate-based Sealer and Epoxy Resin-based Sealer in Single-visit Root Canal Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible, Pain, Postoperative
Keywords
Calcium silicate-based sealer, Epoxy resin-based sealer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epoxy resin-based sealers (ERS)
Arm Type
Active Comparator
Arm Description
After root canal preparation, canal obturation was performed with Epoxy resin-based sealers (ERS)
Arm Title
calcium silicate-based sealers (CSS)
Arm Type
Active Comparator
Arm Description
After root canal preparation, canal obturation was performed with Calcium silicate-based sealers (CSS)
Intervention Type
Drug
Intervention Name(s)
Epoxy resin-based sealers (ERS)
Other Intervention Name(s)
Epoxy resin-based cement
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Calcium silicate-based sealers (CSS)
Other Intervention Name(s)
Calcium silicate-based cement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain intensity over time
Description
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.
Time Frame
after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment
Title
Change in pain relief over time
Description
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.
Time Frame
after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment
Title
Change in treatment outcome evaluation over time
Description
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
Time Frame
1 week, 3 months and 6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of Medicine and Pharmacy at Ho Chi Minh City
City
Ho Chi Minh City
ZIP/Postal Code
72700
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17956561
Citation
Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23.
Results Reference
background
PubMed Identifier
20003932
Citation
El Mubarak AH, Abu-bakr NH, Ibrahim YE. Postoperative pain in multiple-visit and single-visit root canal treatment. J Endod. 2010 Jan;36(1):36-9. doi: 10.1016/j.joen.2009.09.003.
Results Reference
background

Learn more about this trial

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

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