Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers

Endodontically Treated Teeth Clinical Trial

Official title:

Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376033
• Other study ID #: OUTENDOPROSP
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 1, 2022

Study information

• Verified date: May 2022
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Endodontically Treated Teeth
• Tooth, Nonvital

Intervention

Other:
• root canal filling with Ceraseal sealer
root canal filling with Ceraseal sealer

Locations

Country	Name	City	State
Italy	Dental School University of Bologna	Bologna	Emilia-Romagna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing rate	Periapical index minor than 3 at the endline	24 months
Secondary	Survival rate	presence of root canal treated tooth at the endline	24 months