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OpenTrials
Completed

NCT Number: NCT05376033

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.

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dental School University of Bologna

Bologna, Emilia-Romagna, 40125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18-75 years
  • no use of antiresorptive or antiangiogenic drug
  • healthy status (ASA 1 or 2).
  • Needing one or more root canal treatment

Exclusion criteria

  • Teeth with less than 2 walls of structural integrity
  • Wide apexes (>40 diameter)
  • ASA > 3,
  • Any pathology that could compromise bone healing or the immune response,
  • pregnancy or breast feeding
  • heavy smoking (>15 cigarettes/day), (Tverdal & Bjartveit 2006)
  • exposure to radiation therapy focussed on the head and neck region and malignant disease directly involving the jaws.
  • Lacks of occlusal contacts

Treatment and study plan

root canal filling with Ceraseal sealer

Other

root canal filling with Ceraseal sealer

Primary outcomes

  1. Healing rate

    Time frame: 24 months

    Periapical index minor than 3 at the endline

Secondary outcomes

  1. Survival rate

    Time frame: 24 months

    presence of root canal treated tooth at the endline

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 17, 2022
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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