Enamel Caries in Orthodontic Patients
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This randomized double-blind two arm controlled clinical trials evaluates the hypothesis that
      the regular use of a tooth paste containing microcrystalline hydroxylapatite provides a
      caries preventive effect in caries-susceptible individuals undergoing orthodontic therapy
      with fixed appliances which is comparable to the caries preventive effect provided by the
      regular use of a fluoridated tooth paste.
    

Detailed description: 
      Introduction

      According to the criteria of evidence based medicine the use of fluoridated tooth paste as
      well as fluoridated mouth rinses are,with the exception of dietary control, the only proven
      measures for the prevention of dental caries.

      Aim, Study Hypothesis

      The aim of this randomized double-blind, two arm, controlled clinical trial is evaluation of
      the hypothesis that the regular use of a tooth paste containing microcrystalline particles of
      hydroxylapatite in caries-active subjects under orthodontic therapy with fixed appliances
      will provide at least a comparable extent of caries prevention as the regular use of
      fluoridated tooth paste during an observation period of 6 months.

      Material and Methods

      Study subjects will be recruited from juveniles and young adults, age 12-25, displaying high
      (≥105 CFU) salivary counts of caries promoting mutans streptococci and seeking orthodontic
      therapy with fixed appliances. Evaluated parameters are the presence of enamel caries on the
      buccal aspects of teeth 15-25 according to the criteria of the International Caries Detection
      and Assessment System (ICDAS), the presence of gingival inflammation assessed by the Gingival
      Index (GI) the presence of microbial plaque on the evaluated teeth assessed by the Plaque
      Index (PlI) and the extent of mutans streptococci colonization (MS) on the evaluated teeth
      and in saliva using standardized cultivation techniques. Primary endpoint of the study is the
      number and severity of enamel caries lesions according to the ICDAS classification. Exclusion
      criteria are the presence of ICDAS lesion ≥ 3 on the buccal surfaces of teeth 15-25, the
      presence of gingival lesions > GI 2 and the regular use of salivary flow-reducing
      medications.

      At baseline, ICDAS scores, as well as GI, PlI and MS will be recorded followed by the
      incorporation of the fixed orthodontic appliances. Subsequently, using a random list
      participants are provided with a standardized electric tooth brush and a supply of one of the
      two experimental tooth pastes (hydroxylapatite(HA)/fluoride (FL)) to be used 2 x daily for
      the next 6 months. HA-tooth paste contains no fluoride, FL-tooth paste contains stannous
      fluoride and amine fluoride. At days 28, 84 and 168 (end of study) ICDAS, GI, PlI and MS are
      recorded again. Additionally all study participants will receive a full mouth preventive
      professional supragingival tooth cleaning followed by the application of a 1% chlorhexidine
      gel on all tooth surfaces once every 4 weeks during the course of the trial.
    

Intervention name(s): Tooth Brushing HA; Tooth Brushing FL
Intervention type(s): Procedure; Procedure
Intervention description(s): 2x daily repeated cleaning of all teeth using a standardized electric tooth brush and a non-fluoridated tooth paste containing microcrystalline hydroxylapatite.
Professional supragingival tooth cleaning once every 4 weeks with a rubber cup followed by the application of a 1% chlorhexidine gel over the duration of the study (24 weeks).; 2x daily repeated cleaning of all teeth using a standardized electric tooth brush and a fluoridated tooth paste.
Professional supragingival tooth cleaning once every 4 weeks with a rubber cup followed by the application of a 1% chlorhexidine gel over the duration of the study (24 weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dental Caries; Tooth Paste; Orthodontics; Fluorides