Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers

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.

Study Overview

• Status: Completed
• Conditions: Endodontically Treated Teeth
• Intervention / Treatment: Other: root canal filling with Ceraseal sealer

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 Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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; 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; root canal filling with Ceraseal sealer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing rate	Periapical index minor than 3 at the endline	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	presence of root canal treated tooth at the endline	24 months

Collaborators and Investigators

• Sponsor: University of Bologna

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: root canal treatment; healing rate; warm obturation technique; bioceramic sealer
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Tooth, Nonvital
• Other Study ID Numbers: OUTENDOPROSP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No