Clinical Trials Directory

Trials / Completed

CompletedNCT04607395

Pre-operative Radiograph of Deep Carious Lesions as a Predictive Tool for Pulpal Exposure

Pre-operative Radiograph of Deep Carious Lesions as a Predictive Tool for Pulpal Exposure.

Status
Completed
Phase
Study type
Observational
Enrollment
358 (actual)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
8 Years – 80 Years
Healthy volunteers
Not accepted

Summary

Preserving pulpal vitality is a major challenge when excavating deep caries lesions without severe symptomatology. Pulpal exposure alters success of the treatment (dropping from 93% for indirect pulp treatment with selective excavation to 11% for direct pulpotomy) and thus prognosis of dental organ and cost-effectiveness of the treatment. The preoperative x-ray is a complementary examination which allows to estimate the depth of the carious lesion. In clinical practice, it is currently difficult to accurately measure this depth on preoperative radiographs. This lack of precision leads to a decrease in the effective capacity of the operator to predict the risk of pulpal exposure. Their interpretation is considered imprecise and is not used as a diagnostic element. The aim of this study was to determine if the use of pre-operative retroalveolar radiographs can help to predict pulpal exposure risk.

Conditions

Interventions

TypeNameDescription
RADIATIONpre-operative radiographThree hundred and sixty pre-operative radiographs of deep carious lesions and a "contrasted" version of the same set have been screened and annotated by 4 evaluators. Annotations were placed at the dentino-enamel junction, at the floor of the carious lesions, and on pulp chamber wall. From these annotations, the ratios residual dentin thickness/ total dentin thickness were derived. First, inter-evaluator agreement and concordance were assessed. A logistic regression that accounted for measurement error was applied to precisely estimate the capacity of the ratio to predict exposure (reported as odds-ratio).

Timeline

Start date
2015-02-01
Primary completion
2017-08-01
Completion
2020-07-01
First posted
2020-10-29
Last updated
2020-10-29

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04607395. Inclusion in this directory is not an endorsement.