Infiltrating/sealing proximal caries lesions: a 3-year randomized clinical trial

J Dent Res. 2012 Mar;91(3):288-92. doi: 10.1177/0022034511435328. Epub 2012 Jan 17.


This randomized split-mouth controlled clinical trial aimed at assessing the therapeutic effects of infiltration vs. sealing for controlling caries progression on proximal surfaces. Out of 90 adult students/patients assessed at university clinics and agreeing to participate, 39, each with 3 proximal lesions identified radiographically around the enamel-dentin junction to the outer third of the dentin, were included. Lesions were randomly allocated for treatment to test-A (Infiltration: ICON-pre-product; DMG), test-B (Sealing: Prime-Bond-NT; Dentsply), or control-C (Placebo). Primary outcome after 1, 2, and 3 yrs of radiographically observed lesion progression was assessed by an independent examiner blinded to groups, using pair-wise and digital-subtraction readings. No adverse events occurred. In 37 participants assessed after 3 yrs, 10 lesions (A-4; B-2; C-4) progressed deep into dentin and needed operative treatment. The 3-year therapeutic effect, based on pair-wise radiographic readings between infiltration and placebo, was 37.8% (95% CI: 20.5-55.2%) and that between sealing and placebo was 29.7% (95% CI: 20.2-35.0%). One-year follow-up digital-subtraction readings showed significant differences in lesion progression between infiltration and placebo (P = 0.0012) and between sealing and placebo (P = 0.0269). The study showed that infiltration and sealing are significantly better than placebo treatment for controlling caries progression on proximal lesions. No significant difference was seen between infiltration and sealing ( number NCT01417832).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Cariostatic Agents / therapeutic use*
  • Chi-Square Distribution
  • DMF Index
  • Dental Caries / drug therapy*
  • Female
  • Humans
  • Male
  • Pit and Fissure Sealants / therapeutic use*
  • Radiography, Bitewing
  • Single-Blind Method
  • Statistics, Nonparametric
  • Subtraction Technique
  • Young Adult


  • Cariostatic Agents
  • Pit and Fissure Sealants

Associated data