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

Completed

• Conditions: Deep Caries
• Interventions: Radiation: pre-operative radiograph

• Registration Number: NCT04607395
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-01
• Primary Completion: 2017-08-01
• Status Verified: 2020-07
• Study Completion: 2020-07-01
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-10-22
• Last Update Submitted: 2020-10-22
• Study First Posted: 2020-10-29
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pre-operative radiographs of deep carious lesion	pre-operative radiograph	-

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Professeur des Universités- Praticien Hospitalier; 🇫🇷 Lyon, France