Trial document




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  DRKS00005019

Trial Description

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Title

Development of a preventive concept to improve oral health in endurance athletes

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Although the level of care in the field of dental health in Germany has risen steadily in recent decades, caries and caries prevention remain a central theme in Dentistry. The success of preventive dentistry in Germany are among children and adolescents demonstrated by the wide availability of fluoride in the group and individual prophylaxis and the use of pit and fissure sealants (sealing of caries risk purchasing pools through a thin layer of plastic) for some time.
Non-carious tooth structure caused by lesions on the other hand often result from combined effects of erosion, abrasion and attrition. Due to a mutual reinforcement erosion and abrasion are of special value. The "softening" and the immediately following removal of tooth enamel and dentin increase the loss of tooth structure dramatically. Data on the prevalence in the general population show that caries lesions and erosive tooth loss occur in any age group. Individual special risk groups such as endurance athletes were examined in comparison to the general population with regard to the prevalence of erosions in our group already. The main objective of the follow-up study is to determine the preventive effect of commonly available special oral care products on the progression carious lesions and erosions in endurance athletes. The test group consists of amateurs, the endurance sports (mainly triathlon) exercise. Within this group, the test product is output to half of the subjects that will be using it in addition to oral hygiene and be instructed. For this purpose, randomization is performed. Using this data, it should be possible to determine the preventive effect of the test product as compared with normal oral hygiene in endurance athletes. Also, it is desirable that certain risk groups for dental caries and erosion, such as endurance athletes, to help with a special prevention program to promote dental health.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005019
  •   2013/05/27
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  •   yes
  •   Approved
  •   S-566/2012, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   K03.2 -  Erosion of teeth
  •   Caries prevalence, hypersensitivity
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Interventions/Observational Groups

  •   Endurance athletes: Use of test products (CE certified medical devices e.g. toothpastes and mouth rinses) after manufacturers instructions in addition to common oral hygiene products at home for the whole study period
  •   Controlgroup (endurance athletes as well): use of common oral hygiene products at home
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Prevalence of dental erosion (Yes/no)
Prevalence of carious lesions (yes/no)
point of time:
Baseline: t0
After 6 months: t6
After 12 months: t12
After 18 months: t18
After 24 months: t24

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Secondary Outcome

Prevalence of Hypersensitivity (graduation on visual analogue scale (VAS))
point of time:
Baseline: t0
After 6 months: t6
After 12 months: t12
After 18 months: t18
After 24 months: t24

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2013/07/15
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   64   Years
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Additional Inclusion Criteria

subjects older than 18 years
Written informed consent
subjects have sufficient knowledge of German
volunteers fulfill a weekly training schedule of at least 5 hours
subjects are endurance athletes
subjects have no physical limitations or disabilities that do not allow normal oral hygiene

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Exclusion Criteria

Adolescents under 18 years
No written informed consent to participate in study
Lack of sufficient knowledge of German language
volunteers fulfill a weekly training schedule under 5 hours
subjects are no endurance athletes
dental staff or dental students
Physical limitations or disabilities that do not allow the subject to a normal oral hygiene
strong sign of neglected oral hygiene (severe periodontal disease and acute or rapidly progressing caries)
test subject is pregnant or breastfeeding

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg Poliklinik für Zahnerhaltungskunde
    • Ms.  Dr.  Cornelia  Frese 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg Poliklinik für Zahnerhaltungskunde
    • Ms.  Dr.  Cornelia  Frese 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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