Hydroxyapatite-toothpaste and Enamel Caries in the Primary Dentition
Condition: Tooth Decay; Hydroxyapatite; Tooth Demineralization; Tooth Diseases
MeSH terms: Tooth Diseases; Tooth Demineralization; Calcium Metabolism Disorders
Study type: Interventional

Summary: 
      This multicenter, non-inferiority trial randomized, double-blind, active controlled parallel
      group study evaluates the hypothesis that the home regular use of a toothpaste containing
      microcrystalline hydroxylapatite (HAP) (test toothpaste) provides a caries preventive effect
      in caries-active children with primary dentition age 3-6 which is comparable to the caries
      preventive effect provided by the regular use of a fluoridated tooth paste (F) (control
      toothpaste) over observation periods of max. 336 days. Caries development will be assessed
      according to the clinical criteria of the International Caries Detection and Assessment
      System (ICDAS).

      Condition or disease:

      Intervention Procedure: Tooth Brushing HAP or Procedure: Tooth Brushing F
    

Detailed description: 
      According to the criteria of evidence based medicine the use of fluoridated tooth paste (as
      well as fluoridated mouth rinses) with the exception of dietary control, are the only proven
      measures for the prevention of dental caries. Regular tooth brushing with a fluoridated
      toothpaste represents the golden standard of oral care also in the primary dentition
      established by numerous clinical studies.

      Fluorides are widely used for caries prevention. However, particularly in children and
      adolescents the dosage of fluorides in oral care products must be carefully monitored, as
      chronic overdosing of fluoride may negatively interfere with the mineralization of dentin and
      enamel (fluorosis). Therefore the acceptable concentration of fluorides in oral care products
      is limited and regulated by the European Regulation (EC) No. 12223/2009 on cosmetic products:

      REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November
      2009 on cosmetic products "For any toothpaste containing 0.1 to 0.15% fluoride unless it is
      already labelled as contra-indicated for children (e.g. 'for adult use only') the following
      labelling is obligatory: 'Children of 6 years and younger: Use a pea sized amount for
      supervised brushing to minimize swallowing. In case of intake of fluoride from other sources
      consult a dentist or doctor'" Toothpastes suitable for children up to six years may only
      contain 500 ppm due to the risk of increased fluoride uptake by swallowing the toothpaste.
      However, such reduced fluoride contents may also reduce the caries prophylactic efficacy of
      the toothpaste particularly in highly caries-active individuals (Walsh et al. 2010).
      Therefore, especially for children there is a need for efficacious alternative (non-toxic)
      caries-preventing agents.

      Target Question:

      Does the regular use of a fluoride-free, microcrystalline hydroxyapatite (HAP) - containing
      test toothpaste have a non-inferior impact on the incidence of enamel caries in the primary
      dentition compared to the regular use of a fluoridated control toothpaste with proven caries
      preventive efficacy? The aim of this clinical trial is to assess in cohorts of caries-active
      children with primary teeth whether daily tooth brushing at home over observation periods of
      max. 336 days with a hydroxyapatite-containing toothpaste (test toothpaste) provides a
      protection from enamel caries development which is not inferior to the protection when
      brushing with a fluoridated toothpaste (control toothpaste).

      Material and Methods Subjects

      Study subjects will be recruited from a target population of caries-active children with
      primary teeth aged ≥ 3 to 6 years. The target population we be stratified according to the
      number of filled molars:

      There will be 2 strata:

      Stratum A: Children with high risk of caries development. Either 1-2 filled molars or 1-2
      molars with at least ICDAS 4, which will be dentally treated. Thus, 6-7 enamel surfaces can
      be assessed.

      Stratum B: Children with very high risk of caries development. Either 3-4 filled molars or
      3-4 molars with at least ICDAS 4, which will be dentally treated. Thus, 4-5 enamel surfaces
      can be assessed.

      Number of test centers and subjects The trial will be performed at three test centers
      (Poznan, Bialystok, Regensburg) Total number of subjects to be enrolled: n=200

      Methods Test intervention: Oral hygiene instruction and regular domestic application of the
      test toothpaste (3x daily over a period of 336 days); also during weekends and holidays
      Reference (control) intervention: Oral hygiene instruction and regular domestic application
      of the fluoridated (reference) toothpaste (3x daily over a period of 336 days); also during
      weekends and holidays (The reference intervention corresponds to the established scientific
      standard for the prevention of enamel caries in primary teeth).

      The following parameters will be evaluated each three months:

        -  caries development will be assessed according to the clinical criteria of the
           International Caries Detection and Assessment System (ICDAS), (Ismail et al 2007).

        -  changes in the coverage of the assessed primary molars with bacterial plaque according
           to the criteria of the Plaque Control Record.

        -  changes in the status of gingival health in the gingiva of the assessed primary molars
           according to the criteria of the Modified Gingival Index.
    

Intervention name(s): Prophylactic; Cleaning teeth; Restorative dentistry
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): Tooth Brushing HA 3x daily repeated cleaning of all teeth using a standardized electric tooth brush and a non-fluoridated tooth paste containing microcrystalline hydroxylapatite.; Tooth Brushing F 3x daily repeated cleaning of all teeth using a standardized electric tooth brush and a fluoridated tooth paste.; If in a subject a significant increase of carious lesions will be observed, her/his parents are informed about the necessity for further caries preventive measures (e.g. dietary changes, use of fluoride products, reduction of cariogenic microflora with chlorhexidine, xylitol chewing gum, etc.) and caries preventive treatment (removing caries and placing a restoration) by the study centers is offered.
Other intervention name(s): ECIPDEN17; ECIPDEN17
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, double-blind, randomized, active-controlled parallel-group study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dental caries; Toothpaste; Fluoride; Hydroxyapatite