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CompletedNCT05376033Updated May 17, 2022

Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers

An interventional study of root canal filling with Ceraseal sealer in Endodontically Treated Teeth, sponsored by University of Bologna. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-17.

Sponsored by University of Bologna · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Feb 2019, registered May 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
109
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Endodontically Treated Teeth

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Keywords

  • root canal treatment
  • healing rate
  • warm obturation technique
  • bioceramic sealer
03

In context

Tooth, Nonvital

118 studies on the registry are indexed under Tooth, Nonvital; 18 are open to participants now.

This study's enrollment of 109 is above the median of 50 across 108 interventional studies indexed under Tooth, Nonvital.

Browse Tooth, Nonvital studies →

Lead sponsor

University of Bologna is the lead sponsor of 158 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
109 participants (actual)

Study arms

  • Experimental
    Premixed Sealer + Single cone

    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.

    Other: root canal filling with Ceraseal sealer

  • Experimental
    Premixed Sealer + Thermafil

    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.

    Other: root canal filling with Ceraseal sealer

  • Other
    Sealer + Thermafil

    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.

    Other: root canal filling with Ceraseal sealer

Interventions

  • Otherroot canal filling with Ceraseal sealer

    root canal filling with Ceraseal sealer

06

What researchers measure

Primary outcomes

  1. Healing rate

    Periapical index minor than 3 at the endline

    Time frame: 24 months

Secondary outcomes

  1. Survival rate

    presence of root canal treated tooth at the endline

    Time frame: 24 months

07

Study locations

1 site
  • Dental School University of Bologna
    Bologna, Emilia-Romagna 40125, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05376033
Responsible party
Fausto Zamparini (University of Bologna, University of Bologna) — Principal investigator
First posted
May 17, 2022
Start date
Feb 1, 2019
Primary completion
Feb 1, 2022
Completion
Feb 1, 2022
Last update
May 17, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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