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Clinical Trials/NCT04607395
NCT04607395CompletedNot Applicable

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

Hospices Civils de Lyon1 site in 1 country358 target enrollmentStarted: February 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
358
Locations
1
Primary Endpoint
Measurement of residual dentin thickness and total dentin thickness on standard pre-operative radiographs

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
8 Years to 80 Years (Child, Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Measurement of residual dentin thickness and total dentin thickness on standard pre-operative radiographs

Time Frame: 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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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