Sealing Microcavitated Carious Lesions
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study aimed to test whether sealing microcavitated ICDAS 3 carious lesions in permanent
      molars may be arrested by sealing using two different types of materials; a glass ionomer and
      a resin sealant. A Randomized controlled clinical trial was designed. Children between 6 and
      12 years old were recruited and a total of 150 ICDAS 3 lesions in first permanent molars were
      allocated to one of the two arms of the study. Clinical and radiographic lesion progression
      were the main outcome. Integrity of the material and retention were secondary outcomes. A
      follow up period of 24 months with check-ups at 6 and 12 months was considered.
    

Detailed description: 
      Background and problem statement. Traditionally, caries treatment has been based on
      restorative procedures performed by dentist using dental biomaterials. Besides its high cost,
      this canonical approach for caries therapy has very limited coverage and only a small
      proportion of the population can satisfy the high demand. The latter is especially critical
      in developing countries. Available evidence has shown that some caries lesions, either
      cavitated or non-cavitated, may be treated by the placement of sealants. This minimally
      invasive treatment is more cost-effective than the restorative approach and it allows better
      coverage. Sealants placed on the active lesions hamper lesion progression, most likely by
      inhibiting nutrient uptake of the invading associated microbiota. The most commonly used
      material in clinical practice is resin sealant. Despite its advantages and simplicity of use,
      this material is highly sensitive to contamination by saliva or other ubiquitous oral fluids.
      Furthermore, adhesion to enamel is compromised when this tissue is immature. This pitfall of
      the technique is particularly crucial when it comes to treating lesions in erupting molars in
      children. Hence, glass ionomer cement (GI) sealants emerge as a potential alternative to
      resin sealants. GI sealants are more suitable to be used under non-ideal clinical conditions,
      such as in the presence of humidity or on lesions of immature erupting molars. Although there
      exists vast evidence on the use of sealants as preventive agents, studies dealing with this
      biomaterial as a therapeutic agent for caries lesions are more limited and scarce. In regard
      to the material, only few clinical studies with unclear conclusions are available. This
      proposal, therefore, will seek to compare progression of caries lesions treated with either
      resin or GI sealants, in occlusal cavitated lesions (Code 3, ICDAS) of permanent molars of 6
      to 12 year-old children.

      Methodology. A randomized controlled clinical trial (RCT) is proposed. Once approved by the
      Bioethics Committee and after obtaining a signed informed consent from their parents,
      volunteer children will be invited to participate. Two hundred caries lesions (Code 3, ICDAS)
      will be randomized to one of the two arms of the study, resin or GI sealants. The materials
      chosen to conduct the study would be Concise and Ketac Molar, respectively, both from 3M, St.
      Paul, MN. Sample size was estimated using a 95% significance level. Based on the caries
      prevalence of the population and studies performed by the investigators, the number of
      volunteers was estimated to be about one hundred volunteers to gather the required two
      hundred lesions. Three evaluations will be conducted every six months until completion of
      eighteen month of follow-up. All the exams and controls will be performed at the Dental
      Clinics of the University of Talca by one trained and calibrated examiner. Sealants will be
      placed following manufacturer's instructions. Participants will be randomly allocated to
      either study arm, regardless of the clinical indication, so selection bias will be avoided.
      Material retention and lesion progression will be the primary end-point at each control.
      Likewise, caries incidence in untreated teeth will be a secondary outcome of the study.
    

Intervention name(s): Sealants to arrest microcavitated caries.
Intervention type(s): Drug
Intervention description(s): Carious lesions will be treated by minimally invasive dentistry by the use of sealants instead of eliminating carious tissues and using conventional restorative materials.
Other intervention name(s): Carious lesion arrest
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pit and Fissure Sealants; Caries; Glass ionomer; Resin