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

Deep Caries Clinical Trial

— R2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607395
• Other study ID #: R2_2020
• Status: Completed
• Start date: February 1, 2015
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: July 1, 2020
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Caries
• Dental Caries

Intervention

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).

Locations

Country	Name	City	State
France	Professeur des Universités- Praticien Hospitalier	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of residual dentin thickness and total dentin thickness on standard pre-operative radiographs	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).	Outcome measure was assessed trough study completion, an average of 1 year.