Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers

NCT ID: NCT05376033

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2022-02-01

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.

Conditions

Endodontically Treated Teeth

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

root canal filling with Ceraseal sealer

Intervention Type: OTHER

root canal filling with Ceraseal sealer

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.

Group Type: EXPERIMENTAL

root canal filling with Ceraseal sealer

Intervention Type: OTHER

root canal filling with Ceraseal sealer

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.

Group Type: OTHER

root canal filling with Ceraseal sealer

Intervention Type: OTHER

root canal filling with Ceraseal sealer

Interventions

root canal filling with Ceraseal sealer

root canal filling with Ceraseal sealer

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Fausto Zamparini

University of Bologna

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dental School University of Bologna

Bologna, Emilia-Romagna, Italy

Countries

Italy

Other Identifiers

OUTENDOPROSP

Identifier Type: -

Identifier Source: org_study_id