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

NCT ID: NCT04607395

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

358 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-01

Study Completion Date

2020-07-01

Brief Summary

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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

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Conditions

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Deep Caries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pre-operative radiographs of deep carious lesion

pre-operative radiograph

Intervention Type RADIATION

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).

Interventions

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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).

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Professeur des Universités- Praticien Hospitalier

Lyon, , France

Site Status

Countries

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France

References

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Gasqui MA, Perard M, Decup F, Monsarrat P, Turpin YL, Villat C, Gueyffier F, Maucort-Boulch D, Roche L, Grosgogeat B. Place of a new radiological index in predicting pulp exposure before intervention for deep carious lesions. Oral Radiol. 2022 Jan;38(1):89-98. doi: 10.1007/s11282-021-00530-w. Epub 2021 May 5.

Reference Type DERIVED
PMID: 33954908 (View on PubMed)

Other Identifiers

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R2_2020

Identifier Type: -

Identifier Source: org_study_id