Assessment of the Outcome of Endodontic Treatment Using Cone Beam Computed Tomography.

Assessment of the Outcome of Endodontic Treatment Using Cone Beam Computed Tomography-A Prospective Study

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.

Study Overview

• Status: Unknown
• Conditions: Periapical Periodontitis

Detailed Description

Pre-obturation root canal samples were taken using paper points from patients undergoing primary root treatments. The samples were analyzed using a fluorescent spectrometer and a molecular fluorescent vital dye (Calcein AM).

Pre-operative and 1-year post-operative periapical radiographs and Cone Beam Computed Tomography (CBCT) scans were assessed by two calibrated expert examiners to evaluate the outcome of the root canal treatments.

The use of a chairside bacterial stain can allow the clinician to predict the outcome of treatment with confidence. Sampling the root canal space with endodontic paper points followed by ex-situ fluorescent staining and analysis provides a patient-friendly, simple to use and rapid way of predicting root canal treatment outcome.

• Study Type: Observational
• Enrollment (Actual): 65

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periapical periodontium health	Assess the health of periapical periodontium of a tooth by examining the CBCT image	One year

Collaborators and Investigators

• Sponsor: King's College London
• Investigators: Principal Investigator: Shanon Patel, PhD, King's College London

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Jaw Diseases; Periapical Diseases; Periodontitis; Periapical Periodontitis
• Other Study ID Numbers: 08/H0804/79 v.3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No