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

NCT04607395 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 358

Last updated 2020-10-29

No results posted yet for this study

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

  • Deep Caries

Interventions

RADIATION

pre-operative radiograph

Three 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).

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
8 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-01
Primary Completion
2017-08-01
Completion
2020-07-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04607395 on ClinicalTrials.gov