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Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers

U

University of Bologna

Status

Completed

Conditions

Endodontically Treated Teeth

Treatments

Other: root canal filling with Ceraseal sealer

Study type

Interventional

Funder types

Other

Identifiers

NCT05376033
OUTENDOPROSP

Details and patient eligibility

About

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.

Full 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.

Enrollment

109 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

109 participants in 3 patient groups

Premixed Sealer + Single cone
Experimental group
Description:
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.
Treatment:
Other: root canal filling with Ceraseal sealer
Premixed Sealer + Thermafil
Experimental group
Description:
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.
Treatment:
Other: root canal filling with Ceraseal sealer
Sealer + Thermafil
Other group
Description:
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.
Treatment:
Other: root canal filling with Ceraseal sealer

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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