Commentary

Marketing light-based diagnostic devices

Background

The health care research underway is producing new diagnostic methods and many other products. Often these are marketed as essentials for contemporary dental practices. Before incorporating them into clinical practice, however, there should be an objective evaluation of their benefits and potential risks.

Assessment Guidelines

The American Dental Association Clinical Practice Guidelines are developed by experts who appraise and interpret the clinical relevance of the available evidence regarding a topic to develop practice recommendations. Systematic reviews represent the highest level of available evidence. The guidelines and recommendations relevant to dental products are published in peer-reviewed professional journals. However, the marketing undertaken for these products is not constrained and may embellish their

Light-Based Adjunctive Devices

The recent marketing for light-based adjunctive devices has claimed that they markedly improve the practitioner’s ability to discover mucosal abnormalities that might be missed during a routine oral examination. The particular concern is for oral premalignant or malignant lesions.

The US Food and Drug Administration (FDA) has had the authority to regulate medical devices since 1976. The devices are classified into regulatory classes based on the level of control needed to ensure the safety and

Discussion

Taking a complete history and performing a thorough conventional oral examination form the strongest foundation for assessing patients for mucosal abnormalities. Any suspicious lesions or questionable findings can prompt a referral or a biopsy. Findings that are innocuous can be re-evaluated in 2 weeks and referred for further evaluation or a biopsy at that point.