Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00005740

Trial Description

start of 1:1-Block title

Title

The clinical success of the permanent posterior filling alternative Equia-additional cohort.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Study to compare the higher survival rate of a modified glasionomer system compared towards a conventional Glasionomer in combination with a coating material. A participation of a minimum of three dental clinics is assigned.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

A prospective clinical trial as cohort study according to MPG phase IV to compare the survival rate of Equia (Fuji IX GP Extra in combination with G-Coat Plus) with Fuji IX (GIC Fuji IX GP fast in combination with Fuji Coat LC) as filling material for posterior teeth.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005740
  •   2014/03/14
  •   [---]*
  •   no
  •   Approved
  •   BB 124/10, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   K02 -  Dental caries
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Filling with a conventional Glasionomer (Fuji IX GP fast + Fuji Coat LC), 40 fillings
  •   Filling with a modified Glasionomer + Coat (EQUIA System, Fuji IX GP Extra in combination with G-Coat Plus), 40 fillings
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Differences in degree of wear and fillings fracture between both products over a five year period according to a calibrated evaluation based on FDI standard (Hickel et al 2010) beginning from Baseline.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Failure rate of all fillings.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/04/12
  •   240
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

1. Dentate patients (no partial or full dentures, proximately three opposing zones with occlusal contacts of natural teeth in the posterior region), 2. fillings quantity is limited on the multi-surface fillings, 3. the cavity size is limited at 50% of the width of teeth, the proximal walls on the distances of the cusp tip.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

1. Patients with CMD dysfunction or malfunction, 2. signs of occlusal abrasion, hyperfunction, clenching will be excluded from the study. CMD-Screening, 3. Patients who withheld their paticipation will be excluded from the study, 4. none one-surface fillings, none completed or partially cusp replacements.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • GC Europe N.V.
    • Mr.  Piyush  Khandelwal 
    • Interleuvenlaan 33
    • 3001  Leuven
    • Belgium
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • GC Europe N.V.
    • Mr.  Piyush  Khandelwal 
    • Interleuvenlaan 33
    • 3001  Leuven
    • Belgium
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Poliklinik f. Prothetik und Werkstoffkunde Ernst-Moritz-Arndt-Universität
    • Mr.  OA Dr.  Thomas  Klinke 
    • Rotgerberstrasse 8
    • 17487  Greifswald
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • GC Europe N.V.
    • Interleuvenlaan 33
    • 3001  Leuven
    • Belgium
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting stopped after recruiting started
  •   2015/12/18
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.