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Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers

Primary Purpose

Endodontically Treated Teeth

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
root canal filling with Ceraseal sealer
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth focused on measuring root canal treatment, healing rate, warm obturation technique, bioceramic sealer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Teeth with less than 2 walls of structural integrity
  2. Wide apexes (>40 diameter)
  3. ASA > 3,
  4. Any pathology that could compromise bone healing or the immune response,
  5. pregnancy or breast feeding
  6. heavy smoking (>15 cigarettes/day), (Tverdal & Bjartveit 2006)
  7. exposure to radiation therapy focussed on the head and neck region and malignant disease directly involving the jaws.
  8. Lacks of occlusal contacts

Sites / Locations

  • Dental School University of Bologna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Premixed Sealer + Single cone

Premixed Sealer + Thermafil

Sealer + Thermafil

Arm Description

Premixed 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 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.

Epoxy-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.

Outcomes

Primary Outcome Measures

Healing rate
Periapical index minor than 3 at the endline

Secondary Outcome Measures

Survival rate
presence of root canal treated tooth at the endline

Full Information

First Posted
May 3, 2022
Last Updated
May 10, 2022
Sponsor
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT05376033
Brief Title
Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers
Official Title
Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth
Keywords
root canal treatment, healing rate, warm obturation technique, bioceramic sealer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Premixed Sealer + Single cone
Arm Type
Experimental
Arm Description
Premixed 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.
Arm Title
Premixed Sealer + Thermafil
Arm Type
Experimental
Arm Description
Premixed 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.
Arm Title
Sealer + Thermafil
Arm Type
Other
Arm Description
Epoxy-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.
Intervention Type
Other
Intervention Name(s)
root canal filling with Ceraseal sealer
Intervention Description
root canal filling with Ceraseal sealer
Primary Outcome Measure Information:
Title
Healing rate
Description
Periapical index minor than 3 at the endline
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Survival rate
Description
presence of root canal treated tooth at the endline
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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) 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
Facility Information:
Facility Name
Dental School University of Bologna
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40125
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers

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