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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05904184
• Other study ID #: 452/HD-DHYD
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2023
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Pulpitis
• Pulpitis - Irreversible

Intervention

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.
• 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.

Locations

Country	Name	City	State
Vietnam	University of Medicine and Pharmacy at Ho Chi Minh City	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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