NCT03660163

Brief Summary

The aim of the study is to assess the correlation between pre-obturation bacterial detection using fluorescence amplification and outcome of endodontic treatments. Thus, enabling a suitable detection threshold to predict the likelihood of treatment failure. This has the potential to be used a bench side tool in general dental practice to act as a surrogate endpoint for clinicians performing root canal treatment.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

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

November 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 7, 2018

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

September 4, 2018

Last Update Submit

September 6, 2018

Conditions

Periapical Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Periapical periodontium health

    Assess the health of periapical periodontium of a tooth by examining the CBCT image

    One year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to the endodontic postgraduate unit at Guy's Hospital.

You may qualify if:

  • Patients with at least one tooth diagnosed with the endodontic disease.
  • teeth that were tender to percussion and palpation.
  • teeth that had a sinus tract and/ swelling.
  • Both primary treatment teeth and teeth which had already been root treated were considered.

You may not qualify if:

  • Patients were excluded if they were pregnant.
  • Immunosuppressed patients.
  • Non-restorable teeth.
  • Teeth with a periodontal probing depth greater than 3mm.
  • Teeth with apical radiolucencies with the longest dimension above 1.2cm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Knight A, Blewitt I, Al-Nuaimi N, Watson T, Herzog D, Festy F, Patel S, Foschi F, Koller G, Mannocci F. Rapid Chairside Microbial Detection Predicts Endodontic Treatment Outcome. J Clin Med. 2020 Jul 3;9(7):2086. doi: 10.3390/jcm9072086.

    PMID: 32635158DERIVED

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Officials

  • Shanon Patel, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 6, 2018

Study Start

November 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2019

Last Updated

September 7, 2018

Record last verified: 2018-08