Sealing Manifest Occlusal Caries Lesions in the Permanent Dentition
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The research project "SEAL-DK" is focusing on advantages and disadvantages of two treatment
      strategies: non-invasive fissure sealing and invasive restorative treatment of manifest
      occlusal caries lesions in permanent teeth in children and adolescents. The purpose of the
      project is to promote the understanding of the possibilities of non-invasive treatment of
      occlusal caries lesions in the permanent dentition, and to increase the present knowledge
      about the optimal threshold for sealing or restoration, respectively, when treating such
      lesions.

      The project is carried out as a randomized study of the two treatment strategies:
      non-invasive versus invasive treatment of occlusal caries. When organizing the study, it is
      emphasized that no treatment shall be carried out, if conflicting the participating dentists'
      perception of clinically proper caries treatment, and that the results shall have a high
      reliability and consistency.

      The hypothesis is that caries progression can be stopped by non-invasive fissure sealing
      changing the threshold and postponing the time for invasive restoration.
    

Detailed description: 
      Background: The first restoration is fatal for the prognosis of the tooth. Studies have shown
      that caries progression can be stopped with a tight sealing which may even lead to
      re-mineralization of lesions.

      Aim: To investigate the possibility of treating manifest occlusal caries with non-invasive
      sealing instead of conventional resin restoration.

      Study design: the study is carried out as a prospective, randomized clinical study (RCT).
      Primary, occlusal caries lesions in 521 patients, aged 6-17 years old were treated by
      non-invasive resin based sealing (n= 368) or resin based restoration (n=153). The dentists or
      patients were not free to choose the treatment type. Randomization between sealing and
      restoration (2:1) was made by computer for each practitioner at the University of Copenhagen
      and kept at the clinics in sealed envelopes. The treatments are examined clinically and
      radiographically after 1, 2, 3, 5, 7 and 10 years. The treatments are performed and
      controlled by 68 general practitioners from Public Dental Health Care Service in 9 Danish
      municipalities.

      Sealing: The dentists use material of own choice, and follow their usual clinical procedures
      based on the instructions from the manufacturer and the guidelines from The Department of
      Cariology and Endodontics, University of Copenhagen.

      Restoration: The dentists use preparation design and material of own choice, and follow their
      usual clinical procedures based on the instructions from the manufacturer and the guidelines
      from The Department of Cariology and Endodontics, University of Copenhagen.

      The prevalence of regression, arrest and progression of sealed and restored caries lesions,
      are computed and related to the clinical and radiological registrations of patient, dentist
      or treatment related factors for assessing of statistically significant correlations.

      The influence of each factor on the quality, longevity and need for retreatment of occlusal
      sealants and restorations, will be assessed using non-parametric tests and Kaplan-Meier
      survival analyses for statistical treatment of data, supplemented with summarizing
      multivariate survival analyses such as the Cox regression model and discriminatory analyses.
    

Intervention name(s): Non-invasive resin based fissure sealing; Invasive resin based restoration
Intervention type(s): Procedure; Procedure
Intervention description(s): The dentists use resin based fissure sealants of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen, DK; The dentists use preparation design and resin composites of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen, DK
Other intervention name(s): Sealing; Restoration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Occlusal caries; Resin based fissure sealant; Composite resin restoration; Effectiveness; Longevity