Root Canal InfectionNCT03055975
Prevalence of Bacteria Following Endodontic Treatment
An observational study of Root Canal Infection, run by King's College London at 1 site in United Kingdom.
Trial summary
Sampling of accessed root canals with endodontic paper points during treatment and immediately pre-obturation of endodontic root canals was carried out. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Root Canal Infection
- What is being tested?
- Detection of residual vital bacteria in the root canal space
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jan 2013to 30 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients with single or multi-rooted teeth undergoing root canal treatment.
Who cannot join
- For certain aspects of the study secondary treatments and vital teeth are excluded.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London, Dental Institute, Floor 22, Endodontics
London, London, SE1 9RT
Francesco Mannocci, Prof, +44 (0)20 7188 7188, francesco.mannocci@kcl.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Root Canal Infection
- Being tested
- Detection of residual vital bacteria in the root canal space
- Keywords
- Bacteria, Root canal treatment, Endodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of residual vital bacteria in the root canal spaceDiagnostic test
Also called Detection of root canal infection
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Detection of residual vital bacteria in the root canal space | |
| 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 Receives: Diagnostic Test: Detection of residual vital bacteria in the root canal space |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: June 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start30 Jan 2013
- Primary completion30 May 2017 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Root Canal InfectionStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Principal investigator, Dr Federico Foschi, King's College London
- Investigators
- Federico Foschi, Dr, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055975
- Sponsor's protocol ID
- 05/Q0705/051
- Status last verified
- Feb 2017
- First submitted
- 14 Feb 2017
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD is not planned to be made available to other researchers as of yet
Publications
Herzog DB, Hosny NA, Niazi SA, Koller G, Cook RJ, Foschi F, Watson TF, Mannocci F, Festy F. Rapid Bacterial Detection during Endodontic Treatment. J Dent Res. 2017 Jun;96(6):626-632. doi: 10.1177/0022034517691723. Epub 2017 Feb 1.
PubMed 28530469
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Phenotype of Oral Enterococcus Faecalis
- ClinicalTrials.gov ID
- NCT03055975
- Acronym / sponsor ID
- 05/Q0705/051
- Conditions
- Root Canal Infection
- Keywords
- Bacteria, Root canal treatment, Endodontics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 30 Jan 2013 (actual)
- Primary completion
- 30 May 2017 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sampling of accessed root canals with endodontic paper points during treatment and immediately pre-obturation of endodontic root canals was carried out.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary treatments | – | Diagnostic Test: Detection of residual vital bacteria in the root canal spacePatients 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 |
| Re-treatments | – | Diagnostic Test: Detection of residual vital bacteria in the root canal spacePatients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients with single or multi-rooted teeth undergoing root canal treatment.
Key exclusion criteria (1 listed)
- For certain aspects of the study secondary treatments and vital teeth are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of residual vital bacteria in the root canal spaceAlso: Detection of root canal infectionDetection 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. | Diagnostic test | Primary treatments, Re-treatments |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Derived from this study: PubMed 28530469Herzog DB, Hosny NA, Niazi SA, Koller G, Cook RJ, Foschi F, Watson TF, Mannocci F, Festy F. Rapid Bacterial Detection during Endodontic Treatment. J Dent Res. 2017 Jun;96(6):626-632. doi: 10.1177/0022034517691723. Epub 2017 Feb 1.
- Individual participant dataSharing planned: Undecided. IPD is not planned to be made available to other researchers as of yet
Related trials for Root Canal Infection
Active, not recruitingObservational study
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Effect of Temperature Elevation on the Antimicrobial Efficacy of Two Root Canal Irrigants in Primary Root Canal Infections: A Randomized Controlled Clinical Trial
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Nanozymes in Endodontics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico Foschi, Dr principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Root Canal Infection, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico Foschi, Dr (+44 (0)020 7188 7188, federico.foschi@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of residual bacteria during and post root canal treatment (time frame: June 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03055975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.