Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers
1 other identifier
interventional
109
1 country
1
Brief Summary
The clinical use of a flowable premixed calcium-silicate bioceramic sealer used in association with warm carrier-based/single-cone technique will be compared with epoxy resin-based sealer with carrier-based technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 3, 2022
CompletedFirst Posted
Study publicly available on registry
May 17, 2022
CompletedMay 17, 2022
May 1, 2022
3 years
May 3, 2022
May 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Healing rate
Periapical index minor than 3 at the endline
24 months
Secondary Outcomes (1)
Survival rate
24 months
Study Arms (3)
Premixed Sealer + Single cone
EXPERIMENTALPremixed flowable hydraulic calcium silicate sealer was applied with a a K File #15 that was inserted into the canal to reach the WL - 3mm and gently moved around the root canal walls. Then, gutta-percha points were gently inserted at the WL -0.5mm and compacted with lateral condensation/vertical condensation.
Premixed Sealer + Thermafil
EXPERIMENTALPremixed bioceramic sealer was applied and previously described. Pre-heated carrier was inserted in the canal at WL-0.5mm. The carrier excess was removed with a Thermacut bur.
Sealer + Thermafil
OTHEREpoxy-resin-based sealer was mixed and immediately inserted into the root canal using a K File #15. Pre-heated carrier was inserted in the canal at WL -0.5mm. The carriers excess was removed with a bur.
Interventions
root canal filling with Ceraseal sealer
Eligibility Criteria
You may qualify if:
- age 18-75 years
- no use of antiresorptive or antiangiogenic drug
- healthy status (ASA 1 or 2).
- Needing one or more root canal treatment
You may not qualify if:
- Teeth with less than 2 walls of structural integrity
- Wide apexes (\>40 diameter)
- ASA \> 3,
- Any pathology that could compromise bone healing or the immune response,
- pregnancy or breast feeding
- heavy smoking (\>15 cigarettes/day), (Tverdal \& Bjartveit 2006)
- exposure to radiation therapy focussed on the head and neck region and malignant disease directly involving the jaws.
- Lacks of occlusal contacts
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dental School University of Bologna
Bologna, Emilia-Romagna, 40125, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University of Bologna
Study Record Dates
First Submitted
May 3, 2022
First Posted
May 17, 2022
Study Start
February 1, 2019
Primary Completion
February 1, 2022
Study Completion
February 1, 2022
Last Updated
May 17, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share