08 July 2022

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7 years randomized clinical trial on caries infiltration

Co-authors: A. Comba, F. Del Bianco

Lorenzo Breschi

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In compliant patients noninvasive interventions such as fluoridation or flossing may be efficacious to hamper progression of existing proximal caries lesions. However despite all preventive efforts, high caries incidence and progression is reported, in particular for proximal sites.

Microinvasive treatments  such as sealing or caries infiltration could provide a barrier from acids produced by bacteria biofilm thanks to the resin that penetrates into the demineralized substrate.  

A clinical trial performed by S. Paris et al. decided to assess the clinical efficacy of resin infiltration  of proximal caries  lesions after a mean follow-up period of seven years compared to mock treatment.

Material & Methods
The group of research from Berlin included 22 students from dental clinic (age 18-35) with two or more non-cavitated proximal caries lesions with radiolucencies involving the inner half of enamel up to the outer third of dentine. Lesion pairs were randomly allocated by  the German researchers into two treatment groups: infiltration  (Icon, pre-product; DMG) or mock (control) treatment. All subjects received risk-related instructions for diet, flossing and fluoridation. The primary outcome was radiographic (digital subtraction radiography) lesion progression after seven years. Secondly, Kaplan-Meier-analyses were applied to analyze time-to-failure additionally including patients followed up for less than 54 months as well.

Results
After a mean observation period of 48 months, the group of S.Paris et al.  analyzed the outcomes of 17 patients and found out that 2/22 infiltrated lesions (9 %) compared with 10/22 control lesions (45 %) progressed into deeper caries(p = 0.018). The relative risk reduction for test in relation to control was 80 % (CI 95 % = 19–95 %). For the survival analysis within a mean observation time of 73 months failure rates of 1.3 % and 7.8 % were observed for test and controls, respectively. Hazard risk (95 % CI) for caries progression was 6.6 for the control compared with the test lesions (p = 0.002).

Conclusions
The authors concluded that resin infiltration  of proximal caries lesions  extending radiographically around the enamel dentin junction is efficacious to reduce lesion progression after a mean observation time of seven years.

For additional information: Seven-year-efficacy of proximal caries infiltration – Randomized clinical trial.