NCT03055975

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2013

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

4.3 years

First QC Date

February 14, 2017

Last Update Submit

February 16, 2017

Conditions

Keywords

BacteriaRoot canal treatmentEndodontics

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

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

Interventions

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.

Also known as: Detection of root canal infection
Primary treatmentsRe-treatments

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Patients with single or multi-rooted teeth undergoing root canal treatment.

You may not qualify if:

  • For certain aspects of the study secondary treatments and vital teeth are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London, Dental Institute, Floor 22, Endodontics

London, London, SE1 9RT, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

Study Officials

  • Federico Foschi, Dr

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 16, 2017

Study Start

January 30, 2013

Primary Completion

May 30, 2017

Study Completion

October 30, 2018

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations