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NCT03055975 Clinical Trial

Prevalence of Bacteria Following Endodontic Treatment

Root Canal Infection Clinical Trial

Official title:
Prevalence and Phenotype of Oral Enterococcus Faecalis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03055975
Other study ID # 05/Q0705/051
Secondary ID
Status Recruiting
Phase N/A
First received February 14, 2017
Last updated February 16, 2017
Start date January 30, 2013
Est. completion date October 30, 2018

Study information
Verified date February 2017
Source King's College London
Contact Federico Foschi, Dr
Phone +44 (0)020 7188 7188
Email federico.foschi@kcl.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sampling of accessed root canals with endodontic paper points during treatment and immediately pre-obturation of endodontic root canals was carried out.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date October 30, 2018
Est. primary completion date May 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Detection of residual vital bacteria in the root canal space
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.

Locations
Country Name City State
United Kingdom King's College London, Dental Institute, Floor 22, Endodontics London

Sponsors (2)
Lead Sponsor Collaborator
King's College London Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of residual bacteria during and post root canal treatment Using a vital fluorescent stain bacteria sampled from the root canal space were detected during and post root canal treatment. June 2016
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