- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03733938
Microsurgery Using a Bioceramic Root End Filling Material (microsurgery)
November 6, 2018 updated by: Jordan University of Science and Technology
Outcome of Periradicular Microsurgery Using a Bioceramic Root End Filling Material
Endodontic failures are not uncommonly encountered despite improvements in routine root canal therapy.
Endodontic microsurgery is one way to manage such failure.
The placement of a retrograde filling material is considered the most important prognostic factor in endodontic microsurgery.
The aim of this study was to investigate the clinical and radiographic outcome of a fast set bioceramic root end filling material in human teeth.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients who were referred to the endodontic postgraduate clinics in the period between January 2017 till August 2017 were assessed for inclusion in the study according to preset criteria.
Endodontic microsurgery was performed following modern techniques including magnification, root resection with minimal angle, ultrasonic root end preparation and placement of a fast set bioceramic putty as retrograde filling material.
The case was subsequently evaluated clinically and radiographically at 3, 6 and 12 months.
And will be followed subsequently at 2 years and 4 years post treatment.
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
IRbid, Jordan, 21110
- Dental teaching centre
-
-
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
16 years to 70 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All eligible patients attending the postgraduate clinics over a 7 months period and meet the inclusion criteria will be included in the study
Description
Inclusion Criteria:
- medically fit patient
- Tooth has adequate coronal seala nd judged restorable
- previously root filled tooth with persistent periapical lesion
- previously retreated tooth with persistent symptoms 5.previously tretaed tooth with inaccessable canal for retreatment 6. combined nonsurgical and surgical approach for teeth with large periapical lesions
Exclusion Criteria:
- medically compromised patients
- nonrestorable teeth cracked roots
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
teeth with failed root canal treatement
endodontic microsurgery will be performed for teeth with failed root canal treatment
|
teeth with failed root canal treatment will be treated by endodontic microsurgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resolution of signs of failure in the root treated tooth
Time Frame: 6 months -1 year
|
symptoms should disappear and signs of bone healing should be evident on the radio graph
|
6 months -1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 6, 2017
Primary Completion (Actual)
August 7, 2017
Study Completion (Actual)
August 5, 2018
Study Registration Dates
First Submitted
November 5, 2018
First Submitted That Met QC Criteria
November 6, 2018
First Posted (Actual)
November 7, 2018
Study Record Updates
Last Update Posted (Actual)
November 7, 2018
Last Update Submitted That Met QC Criteria
November 6, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 316/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
participant data can be shared after the first publication from the study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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