Radiographic Progression of Sealed and Infiltrated Caries Lesions in Vivo
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study was to compare with a clinical randomized controlled split-mouth
      design study the changes in the therapeutic effect of infiltrating versus sealing proximal
      caries lesions and placebo treatment after 1, 2 and 3 years. The outcome was lesion
      progression, evaluated by radiographic techniques.
    

Detailed description: 
      Fissure sealing has been shown to inhibit not only the formation of occlusal caries but also
      to impede the progression of existing caries lesions. Lately, the concept of sealing caries
      to arrest lesion progression has been transferred to approximal surfaces. In a clinical study
      sealed approximal lesions showed significantly reduced progression after 18 month compared
      with those that were treated only with preventive measures.

      The pores of enamel caries lesions provide diffusion pathways for acids and dissolved
      minerals. The aim of caries infiltration is to occlude these pores by infiltration with light
      curing resins in order to block the diffusion of acids into the lesion body. In contrast to
      caries sealing, caries infiltration aims to occlude the pores within the lesion rather then
      placing a diffusion barrier on the lesion surface. Several studies showed significantly
      reduced progression of infiltrated enamel lesions in demineralizing environments.

      This split-mouth placebo-controlled randomized clinical trial was conducted on 16-35 year-old
      subjects in Bogotá, Colombia (IRB UB.162-2008).

      The sample size calculated was of minimum 29 patients with 3 approximal lesions around the
      EDJ or in the dentin outer third.

      The study population was students and patients from Unversidad El Bosque. Two visits were
      planned for the patients within same week. In the first visit baseline standardized bitewing
      radiographs were obtained and 3 proximal selected lesions were randomly selected. A clinical
      examination was conducted to assess DMF-T/S, and individual caries risk. Elastic orthodontic
      bands were placed between teeth of selected surfaces for elective temporary separation.

      In the second visit selected lesions were visually classified with ICDAS criteria and
      activity status of lesions was assessed. The 3 lesions were randomly allocated to: A.
      Infiltration, B. Sealing, C. Placebo, and lesions were treated.

      Subjects were clinically examined after one, two, and three years by two examiners (AC, JSL)
      blinded to the selected treatment groups and referral for operative treatment were done if
      needed. Standardized bitewing radiographs were made each year.

      Lesions progression was assessed on radiographs by pair-wise reading by an external examiner
      blinded to groups. Additionally, after one year reading of images was conducted by
      digital-subtraction radiography of scanned images. For reproducibility assessment the
      examiner repeated 20% of radiograph readings by both methods one week after the first
      reading.

      Statistical analysis Intra-examiner reliability for radiographs readings was assessed by
      unweighted kappa scores; caries experience (DMF-T/S), individual caries risk levels, ICDAS
      criteria, radiographic scores, and progression' status of selected lesions were reported
      descriptively.

      The outcome variable of changes in lesion progression after 1, 2 and 3 years was assessed by
      pair-wise radiographic reading and after one year also by digital-subtraction radiography.

      Differences in lesion progression between treatments at each follow-up were tested by the
      Cochran Q test and in case of significant difference between groups, by the McNemar Change
      test, including the therapeutic effect and the 95% confidence intervals [Siegel & Castellan,
      1988].

      In all tests p-values less than 0.05 were considered significant.
    

Intervention name(s): Resin infiltration / adhesive; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Treatment at baseline of one caries lesion with a resin infiltration conducted under rubber-dam isolation with the Icon-DMG pre-product; treatment at baseline of another caries lesion with an adhesive under rubber-dam isolation with the Prime Bont NT - Dentsply.; In this split-mouth design study, one of the three randomly selected approximal lesions will be treated with an infiltrant resin, one will be treated with an adhesive resin.
Other intervention name(s): Infiltrant: Icon pre-product, DMG; Adhesive: Prime Bond NT, Dentsply; Placebo (cleaning of surface)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental caries; Proximal surfaces; Preventive therapy; Dental radiography; Treatment efficacy; Young adults