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Clinical Trials/NCT05376033
NCT05376033
Completed
Not Applicable

Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers

University of Bologna1 site in 1 country109 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endodontically Treated Teeth
Sponsor
University of Bologna
Enrollment
109
Locations
1
Primary Endpoint
Healing rate
Status
Completed
Last Updated
3 years ago

Overview

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.

Detailed Description

Healthy consecutive patients (n= 109) requiring 141 root canal treatments were enrolled in this study and divided in 3 groups (Group 1: Ceraseal + single cone cold technique n=47. Group 2: Ceraseal + Carrier-based technique n=47. Group 3 AH Plus + Carrier based technique n=47). Periapical X-rays were taken preoperatively, after root canal filling and after 6, 12 and 24 months. Two evaluators blindly assessed the Periapical Index (PAI) and sealer extrusion in the 3 groups (k =0.90). Healing rate and survival rate were also analysed. Chi square tests was used to analyse significant differences among the groups. Multilevel analysis was performed to analyse the factors associated to healing status and survival status.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
February 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Bologna
Responsible Party
Principal Investigator
Principal Investigator

Fausto Zamparini

University of Bologna

University of Bologna

Eligibility Criteria

Inclusion Criteria

  • age 18-75 years
  • no use of antiresorptive or antiangiogenic drug
  • healthy status (ASA 1 or 2).
  • Needing one or more root canal treatment

Exclusion Criteria

  • Teeth with less than 2 walls of structural integrity
  • Wide apexes (\>40 diameter)
  • 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

Outcomes

Primary Outcomes

Healing rate

Time Frame: 24 months

Periapical index minor than 3 at the endline

Secondary Outcomes

  • Survival rate(24 months)

Study Sites (1)

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