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

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City (Other)

Overall Status

Completed

CT.gov ID

NCT05904184

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pulpitis - Irreversible Pain, Postoperative	Drug: Epoxy resin-based sealers (ERS) Drug: Calcium silicate-based sealers (CSS)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2020

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Epoxy resin-based sealers (ERS) After root canal preparation, canal obturation was performed with Epoxy resin-based sealers (ERS)	Drug: 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. Other Names: Calcium silicate-based cement
Active Comparator: calcium silicate-based sealers (CSS) After root canal preparation, canal obturation was performed with Calcium silicate-based sealers (CSS)	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. Other Names: Epoxy resin-based cement

Arm

Intervention/Treatment

Active Comparator: Epoxy resin-based sealers (ERS)

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

Drug: 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.

Other Names:

Calcium silicate-based cement

Active Comparator: calcium silicate-based sealers (CSS)

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

Drug: Epoxy resin-based sealers (ERS)

Other Names:

Epoxy resin-based cement

Outcome Measures

Primary Outcome Measures

Change in pain intensity over time [after 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 time [after 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 treatment outcome evaluation over time [1 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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