- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03055975
Prevalence of Bacteria Following Endodontic Treatment
February 16, 2017 updated by: Dr Federico Foschi, King's College London
Prevalence and Phenotype of Oral Enterococcus Faecalis
Sampling of accessed root canals with endodontic paper points during treatment and immediately pre-obturation of endodontic root canals was carried out.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Following ethical approval (REC ref: 05/Q0705/051), informed consent was obtained from patients undergoing root canal treatment.The teeth included in the study had been referred to a specialist centre for the treatment of endodontic infection.
They all responded negatively to vitality tests and presented pre-operative apical radiolucencies.
The source population were referred by their general dental practitioner into specialist endodontic clinics of Guy's Hospital, King's College London Dental Institute.Treatments on the teeth were carried out by a total of 19 postgraduate endodontic students.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Federico Foschi, Dr
- Phone Number: +44 (0)020 7188 7188
- Email: federico.foschi@kcl.ac.uk
Study Contact Backup
- Name: Dylan Herzog, Mr
- Phone Number: +44 (0)207 188 1789
- Email: dylan.b.herzog@kcl.ac.uk
Study Locations
-
-
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London, United Kingdom, SE1 9RT
- Recruiting
- King's College London, Dental Institute, Floor 22, Endodontics
-
Contact:
- Francesco Mannocci, Prof
- Phone Number: +44 (0)20 7188 7188
- Email: francesco.mannocci@kcl.ac.uk
-
-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The source population are adults aged 18-65, referred by their general dental practitioner into specialist endodontic clinics of Guy's Hospital, King's College London Dental Institute.
Both single- and multi-rooted non-vital teeth are included in the study
Description
Inclusion Criteria:
- Patients with single or multi-rooted teeth undergoing root canal treatment.
Exclusion Criteria:
- For certain aspects of the study secondary treatments and vital teeth are excluded.
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
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Primary treatments
Patients undergoing primary root canal treatments.
Only teeth which have not previously been accessed are included in this cohort.The source population are adults aged 18-65, referred by their general dental practitioner into specialist endodontic clinics of Guy's Hospital
|
Detection of residual vital bacteria in the root canal space.
No intervention, as it is an observational study.
Vital bacteria are looked for in the samples taken from the root canal space.
Other Names:
|
Re-treatments
Patients undergoing re-treatments.
Only teeth which had a previous root canal treatment which failed are included in this cohort.The source population are adults aged 18-65, referred by their general dental practitioner into specialist endodontic clinics of Guy's Hospital
|
Detection of residual vital bacteria in the root canal space.
No intervention, as it is an observational study.
Vital bacteria are looked for in the samples taken from the root canal space.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection of residual bacteria during and post root canal treatment
Time Frame: June 2016
|
Using a vital fluorescent stain bacteria sampled from the root canal space were detected during and post root canal treatment.
|
June 2016
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Federico Foschi, Dr, King's College London
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 30, 2013
Primary Completion (Anticipated)
May 30, 2017
Study Completion (Anticipated)
October 30, 2018
Study Registration Dates
First Submitted
February 14, 2017
First Submitted That Met QC Criteria
February 14, 2017
First Posted (Actual)
February 16, 2017
Study Record Updates
Last Update Posted (Actual)
February 17, 2017
Last Update Submitted That Met QC Criteria
February 16, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 05/Q0705/051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
IPD is not planned to be made available to other researchers as of yet
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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