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Clinical Trials in Italy / NCT06252337
Active, not recruiting Not applicable

Survival and Success of Two Different Filling Techniques

NCT06252337 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Bologna
Phase
Not applicable
Started
2023-01-01
Last updated
2026-02-27

Condition(s) studied

Periapical DiseasesBioceramic SealersSurvival RateHealing Rate

Investigational drug(s) / intervention(s)

bioceramic sealer group

bioceramic sealer group: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Age 18-75 years 2. Healthy status (ASA 1 or 2) 3. At least one tooth affected by endodontic pathology (pulpitis, pulp necrosis, re-exacerbated lesions with a previous root canal treatment) (b) Exclusion Criteria: 1. Teeth with less than 2 walls of crown structural integrity 2. Teeth used as abutments for fixed rehabilitation 3. Presence of active periodontal disease (PPD \> 4 mm, general BoP \> 25% of the sites) 4. Wide apexes (\>40 diameters) or absence of radiographic pulp chamber 5. Any systemic pathology that could compromise bone healing or the immune response (i.e., diabetes) 6. Pregnancy or breastfeeding 7. Heavy smoking (\>15 cigarettes/day) 8. Exposure to radiation therapy focused on the head and neck region and malignant disease directly involving the jaws. 9. Lack of occlusal contacts

Primary outcome measure(s)

  • Survival rate — 12 months, 24 months
    number of teeth still functional at the endline
  • Healing rate — 3 months, 6 months 12 months, 24 months
    number of teeth with no periapical lesion at the endline using periapical index (PAI)

Trial sites (1)

FacilityCityRegionStatus
Endodontic clinical section, DIBINEM, UNiversity of Bologna Bologna Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06252337 on ClinicalTrials.gov ↗ ← All trials in Italy