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

Periapical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03660163
• Other study ID #: 08/H0804/79 v.3
• Status: Active, not recruiting
• Start date: November 1, 2016
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2018
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periapical Periodontitis
• Periodontitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periapical periodontium health	Assess the health of periapical periodontium of a tooth by examining the CBCT image	One year