- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04249206
Outcome of Endodontic Treatment in Patient Treated With a Hydraulic Sealer
January 29, 2020 updated by: Giulia Bardini, Cittadella Universitaria
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hydraulic Sealer Group
The single-cone obturation technique is based on a master cone of gutta-percha in conjunction with a hydraulic sealer. Hydraulic endodontic cements exhibit excellent hydraulic properties, biocompatibility and bioactivity. |
|
Active Comparator: Zinc oxide-eugenol Sealer Group
The continuous wave of condensation of gutta-percha and a zinc oxide-eugenol (ZOE) sealer is a gold standard in endodontic obturation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Periapical Healing
Time Frame: 4 year
|
Clinical and radiographic evidence of the absence of apical periodontitis or healing of each tooth (PAI score <2)
|
4 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tooth survival
Time Frame: 4 year
|
Success was defined if the tooth was asymptomatic and considered to be functional regardless of its PAI score
|
4 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
January 28, 2020
First Submitted That Met QC Criteria
January 29, 2020
First Posted (Actual)
January 30, 2020
Study Record Updates
Last Update Posted (Actual)
January 30, 2020
Last Update Submitted That Met QC Criteria
January 29, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETEBCB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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