R2: Pre-operative Radiograph of Deep Carious Lesions as a Predictive Tool for Pulpal Exposure

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT04607395
Collaborator
(none)
358
1
65
5.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: pre-operative radiograph

Study Design

Study Type:
Observational
Actual Enrollment :
358 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pre-operative Radiograph of Deep Carious Lesions as a Predictive Tool for Pulpal Exposure.
Actual Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
pre-operative radiographs of deep carious lesion

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).

Outcome Measures

Primary Outcome Measures

  1. Measurement of residual dentin thickness and total dentin thickness on standard pre-operative radiographs [Outcome measure was assessed trough study completion, an average of 1 year.]

    The radiographic assessment consisted in determining the depth of each carious lesion from the pre-operative radiographs and from their contrasted version. In this work, the depth of one carious lesion was measured by the ratio (expressed in percent): 100*residual dentin thickness (RDT)/ Total dentin thickness (TDT). 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

-pre-operative radiographs of deep carious lesions treated with DECAT protocole, unless they were out of the study.

Exclusion Criteria:
  • Impossibility to assess carious lesion on radiograph, and amalgam restorations that impairs correct examination of carious lesion

  • Radiographs of poor quality and screen captures

Contacts and Locations

Locations

Site City State Country Postal Code
1 Professeur des Universités- Praticien Hospitalier Lyon France 69008

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04607395
Other Study ID Numbers:
  • R2_2020
First Posted:
Oct 29, 2020
Last Update Posted:
Oct 29, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 29, 2020