Clinical trial NCT05904184: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulpitis - Irreversible
Pain, Postoperative
Keywords: Calcium silicate-based sealer
Epoxy resin-based sealer
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change in pain intensity over time
timeFrame: after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment
measure: Change in pain relief over time
timeFrame: after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment
measure: Change in treatment outcome evaluation over time
timeFrame: 1 week, 3 months and 6 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University of Medicine and Pharmacy at Ho Chi Minh City
Study officials:
References:
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.
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.