Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers

Not Applicable

Completed

• Conditions: Endodontically Treated Teeth
• Interventions: Other: root canal filling with Ceraseal sealer

• Registration Number: NCT05376033
• Lead Sponsor: University of Bologna

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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-10
• Last Update Submitted: 2022-05-10
• Study First Posted: 2022-05-17
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sealer + Thermafil	root canal filling with Ceraseal sealer	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.
Premixed Sealer + Single cone	root canal filling with Ceraseal sealer	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 Sealer + Thermafil	root canal filling with Ceraseal sealer	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.

Primary Outcome Measures

Name	Time	Method
Healing rate	24 months	Periapical index minor than 3 at the endline

Secondary Outcome Measures

Name	Time	Method
Survival rate	24 months	presence of root canal treated tooth at the endline

Trial Locations

Locations (1)

Dental School University of Bologna; 🇮🇹 Bologna, Emilia-Romagna, Italy