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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04249206
Other study ID # ETEBCB
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date May 1, 2016
Est. completion date December 2021

Study information

Verified date January 2020
Source Cittadella Universitaria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the study is to evaluate and compare, clinically and radiographically, the outcome of non surgical primary/secondary root canal treatment using a hydraulic sealer or a zinc oxide-eugenol sealer.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 54
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- a permanent, single or multi-rooted mature tooth

- clinical diagnosis of irreversible pulpitis

- diagnosis of apical periodontitis

Exclusion Criteria:

- subjects with immune-compromised status

- subjects with an overall poor prognosis for their treatment

Study Design


Intervention

Procedure:
Root Canal Treatment


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cittadella Universitaria

Outcome

Type Measure Description Time frame Safety issue
Primary Periapical Healing Clinical and radiographic evidence of the absence of apical periodontitis or healing of each tooth (PAI score <2) 4 year
Secondary tooth survival Success was defined if the tooth was asymptomatic and considered to be functional regardless of its PAI score 4 year
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