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

• Conditions: Periapical Periodontitis

• Registration Number: NCT03660163
• Lead Sponsor: King's College London

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.

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 Timeline

• Study Start: 2016-11-01
• Status Verified: 2018-08
• Primary Completion: 2018-08-01
• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-06
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-07
• Study Completion: 2019-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Periapical periodontium health	One year	Assess the health of periapical periodontium of a tooth by examining the CBCT image