NCT06252337

Brief Summary

This randomized clinical study analysed the clinical use of a new bioceramic premixed CaSi-containing sealer in association with a warm carrier-based technique or a traditional epoxy resin based sealer. Methodology: Healthy patients requiring root canal treatments were enrolled. Periapical X-rays were taken preoperatively, after root canal filling and after 1, 6, and 12 and 24 months. Two evaluators assessed the Periapical Index (PAI) and the sealer extrusion. The healing rate and survival rate were also evaluated. Barnard test was used to assess the relationship of each potential prognostic factor with periapical index (PAI) at 12-month follow-up. The significance level was set at 0.05.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress96%
Jan 2023Jun 2026

Study Start

First participant enrolled

January 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

February 1, 2024

Last Update Submit

February 25, 2026

Conditions

Periapical DiseasesBioceramic SealersHealing RateSurvival Rate

Keywords

calcium silicate sealersperiapical lesionendodontic treatment

Outcome Measures

Primary Outcomes (2)

  • Survival rate

    number of teeth still functional at the endline

    12 months, 24 months

  • Healing rate

    number of teeth with no periapical lesion at the endline using periapical index (PAI)

    3 months, 6 months 12 months, 24 months

Secondary Outcomes (1)

  • Post operative pain

    at the moment of root canal filling, at 1 day, 7 days, 28 days

Study Arms (2)

Thermafil AH Plus bioceramic test group

EXPERIMENTAL

Test Group\_ A premixed CaSi-containing bioceramic sealer (Ah Plus Bioceramic, Dentsply, Konstanz, Germany) was used in association with a warm carrier-based technique (Thermafil, Dentsply, Konstanz, Germany). AH Plus Bioceramic is mostly composed of zirconium dioxide (50-70%) as a radiopacifier and tricalcium silicate (10-15%) as a bioactive component. Dimethyl sulfoxide and traces of lithium carbonate and thickening agents are also reported by the manufacturer.The sealer was inserted in the canal and the carrier was warmed in a dedicated oven (thermaprep) and inserted within 60 seconds.

Other: bioceramic sealer group

Thermafil AH Plus control group

OTHER

Control Group\_ an epoxy resin based sealer (Ah Plus, Dentsply, Konstanz, Germany) was used in association with a warm carrier-based technique (Thermafil, Dentsply, Konstanz, Germany). The sealer was inserted in the canal and the carrier was warmed in a dedicated oven (thermaprep) and inserted within 60 seconds.

Other: bioceramic sealer group

Interventions

bioceramic sealer groupOTHER

epoxy resin based + carrier based technique group. The sealer was inserted in the canal and the carrier was warmed in a dedicated oven (thermaprep) and inserted within 60 seconds.

Also known as: control group
Thermafil AH Plus bioceramic test groupThermafil AH Plus control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years
  • Healthy status (ASA 1 or 2)
  • At least one tooth affected by endodontic pathology (pulpitis, pulp necrosis, re-exacerbated lesions with a previous root canal treatment) (b)

You may not qualify if:

  • Teeth with less than 2 walls of crown structural integrity
  • Teeth used as abutments for fixed rehabilitation
  • Presence of active periodontal disease (PPD \> 4 mm, general BoP \> 25% of the sites)
  • Wide apexes (\>40 diameters) or absence of radiographic pulp chamber
  • Any systemic pathology that could compromise bone healing or the immune response (i.e., diabetes)
  • Pregnancy or breastfeeding
  • Heavy smoking (\>15 cigarettes/day)
  • Exposure to radiation therapy focused on the head and neck region and malignant disease directly involving the jaws.
  • Lack of occlusal contacts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endodontic clinical section, DIBINEM, UNiversity of Bologna

Bologna, 40125, Italy

Location

MeSH Terms

Conditions

Periapical Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Jaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 9, 2024

Study Start

January 1, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

IT(1)