Trial document




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  DRKS00005191

Trial Description

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Title

Identifying risk factors for dental erosion - is salivary enzyme activity a
biomarker?

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Trial Acronym

EASY1

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Erosion is the dental hard tissue loss due to the direct impact of acids on clean
tooth surfaces. In the general population, the occurrence of erosion is low;
however, in persons with risk factors, such as high consumption of acidic soft
drinks, in persons suffering from reflux or eating disorders in combination with
chronic vomiting, erosion can be diagnosed quite often. It is well known that
different types of acids have different impact on the dental hard tissue. The
impact of different components of saliva on erosion progression has only been
rarely investigated. It is quite conceivable that certain factors in the saliva,
enzymes, modulate erosion progression.
The aim of this study is therefore to investigate whether between persons with
and without erosion of different origin differences in activity of such factors from
the own saliva exist.
Perspectively, the study could help to develop new and perhaps more effective
strategies for the therapy of dental erosion.

How will the study be performed?

After informing you about all aims and intentions of the study, we will check
whether you can participate in the study. If yes, we will make a dental
examination, take impressions of both of your jaws and prepare dental casts.
If you suffering from an underlying disease (Reflux or eating disorder), we will talk
with you about the disease. Additionally, we will ask questions about your
nutrition. Afterwards, we will ask you to give saliva for two times: resting saliva
and saliva after stimulation due to chewing.
The saliva will now be prepared for analyses. We will measure the activity of
various enzymes, the flow rate of saliva, meaning how much saliva is produced
with and without stimulation, the pH (the acidity) of your saliva and the ability of
the saliva to buffer acids (buffering capacity).

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Brief Summary in Scientific Language

Dental erosion is caused by acids of non-bacterial origin. Particularly in cases of
frequent exposures to exogenous (dietary) or endogenous (gastric) acids, it can
cause serious defects, pain and dysfunction. Though the impact of acids has
clearly been identified as aetiological factor, there is often no relation betweendegree of acid exposure and severity of erosive defects. Saliva is assumed to be
an important erosion protecting factor, but so far, there is no evidence that
parameters like impaired flow rate or low buffering capacity are associated with a
higher risk of erosive loss. However, current results from an own pilot study
revealed that in patients with eating disorders and chronic vomiting the
occurrence of erosive lesions was strongly associated with the activity of specific
proteolytic enzymes, highlighting the role of salivary enzymes as modulating
factors and potential biomarkers. Whether this is specifically related to patients
with eating disorders or whether this is also true for patients with reflux disease
and with dietary acid exposures is unclear. The aim of this basic research study is
therefore to investigate whether proteolytic enzyme activity in saliva is a general
biomarker for erosion risk. Subjects with intrinsic (eating disorders; gastrooesophageal
reflux) and extrinsic (dietary) acid exposures will be included. Target
criteria are the activity of proteolytic enzymes (general proteolytic activity,
collagenase, pepsin, trypsin); control parameters are flow rate, pH, buffering
capacity, as well as enzyme activity of peroxidase, lysozyme and amylase.

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Organizational Data

  •   DRKS00005191
  •   2013/08/06
  •   [---]*
  •   yes
  •   Approved
  •   54/13, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

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Health Condition or Problem studied

  •   K03.2 -  Erosion of teeth
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Interventions/Observational Groups

  •   Analysis of various salivary parameters in resting saliva and stimulated
    saliva in persons with erosion of different etiology (parameters: enzymatic
    activity, flow rate, pH, buffering capacity)
  •   Analysis of salivary parameters in a control group not suffereing from erosion
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Blinded
  •   assessor
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Activity of oral proteolytic enzymes (pepsin, trypsin, salivary collagenases,
general proteolytic activity); correlation of activity with type of acid and with
occurence of erosion

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Secondary Outcome

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Countries of Recruitment

  •   Germany
  •   Norway
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   [---]*
  •   150
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

age of consent; informed written consent; Groups suffering from erosion: BEWE score of at least 2 in at least two sextants

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Exclusion Criteria

cavitated carious lesions; insufficient fillings reaching the dentine; deep and inflamed periodontal pockets (≥ 4 mm with bleeding); other serious inflammatory processes in the oral cavity; allergy against the used dental materials

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Addresses

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    • Medizinische Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für Zahnerhaltungskunde und Präventive Zahnheilkunde
    • Ms.  PD Dr.  Nadine  Schlüter 
    • Schlangenzahl 14
    • 35392  Gießen
    • Germany
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    • UniversitätsZahnMedizin Dresden Poliklinik für Zahnerhaltung
    • Mr.  Prof. Dr.  Christian  Hannig 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Medizinisches Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik fürZahnerhaltungskunde und Präventive Zahnheilkunde
    • Ms.  PD Dr.  Nadine  Schlüter 
    • Schlangenzahl 14
    • 35392  Giessen
    • Germany
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    • Medizinische Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für Zahnerhaltungskunde und Präventive Zahnheilkunde
    • Ms.  PD Dr.  Nadine  Schlüter 
    • Schlangenzahl 14
    • 35392  Gießen
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • beantragt bei 
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting withdrawn before recruiting started
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.