The use of FDI criteria in clinical trials on direct dental restorations: A scoping review.

Objectives: A scoping review was conducted to explore the use of FDI criteria 10 years after their introduction. The first aim was to compare the amount of studies using the FDI and/or the modified USPHS criteria. The second aim was to analyse the use of the FDI criteria in clinical trials evaluating direct dental restorations.

Data: Listing of studies using FDI and/or USPHS criteria per year since 2007. Clinical studies related to the assessment of direct restorations using FDI criteria.

Source: Two systematic searches - regarding the use of FDI and modified USPHS criteria - were carried out on Medline/Pubmed in order to identify the studies published between 2007 and 2017. Authors of the included articles were contacted to clarify their choice of FDI criteria in their studies. ClinicalTrials.gov database was also queried for the on-going studies that use FDI and modified USPHS criteria.

Study Selection: In the first review, all the clinical trials (randomized/non-randomized, controlled, prospective/retrospective studies) that used FDI criteria to evaluate direct restorations on primary or permanent teeth were included.

Conclusions: 16.3% of the studies used FDI criteria. The percentage of studies using them increased from 4.5% in 2010 to 50.0% in 2016. In average, 8.5 FDI criteria were used. The most employed criteria were: marginal adaptation (96.7%), staining (90.0%), fracture of material and retention (90.0%), recurrence of caries/erosion/abfraction (90.0%), post-operative sensitivity/tooth vitality (86.7%) and surface luster (60.0%). In addition, among the 27 on-going studies from ClinicalTrials.gov database, 51.9% use FDI criteria (including 87.5% with an open recruitment status).

Clinical Significance: FDI criteria were reported as practical (various and freely selectable), relevant (sensitive as well as appropriate to current restorative materials and clinical studies design), standardized (making comparisons between investigations easier). Investigators should go on using them for a better standardization of their clinical judgment, allowing comparisons with other studies.