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

NCT04607395 | Completed

• 1 other identifier: R2_2020
• Study Type: observational
• Target: 358
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Caries

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

pre-operative radiographs of deep carious lesion

Radiation: pre-operative radiograph

Interventions

pre-operative radiograph 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).

pre-operative radiographs of deep carious lesion

Eligibility Criteria

• Age: 8 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pre-operative radiographs of deep carious lesions treated with DECAT

You may qualify if:

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

You may not qualify if:

• Impossibility to assess carious lesion on radiograph, and amalgam restorations that impairs correct examination of carious lesion
• Radiographs of poor quality and screen captures

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Professeur des Universités- Praticien Hospitalier

Lyon, 69008, France

Location

Related Publications (1)

• 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.

  PMID: 33954908 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: October 29, 2020
• Study Start: February 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: July 1, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-07

Locations

FR (1)