Trial document




drksid header

  DRKS00000186

Trial Description

start of 1:1-Block title

Title

Prospective clinical study of the effect of different attachments on oral structures

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

The study should examine the effect of different attachments for removable dentures on the tissues of the oral cavity. Especially the periodontal ligament, tooth mobility and bone resorbtion should be studied.

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

Brief Summary in Scientific Language

The effect of the dentures of the patients on oral structures will be measured by the change of tooth mobility, pressure marks and a quantification of the necessity of relining. These parameters should allow conclusions on the bone resorbtion. The tooth mobility is measured in oro-vestibular direction by using Periotest-S (Gulden-Medizintechnik) and also in mesio-distal direction by using a especially constructed device.

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

Organizational Data

  •   DRKS00000186
  •   2009/09/29
  •   [---]*
  •   yes
  •   Approved
  •   Vorlage Nr. 104/09, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1111-8467 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Z46.3 -  Fitting and adjustment of dental prosthetic device
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Partial fixed and removable dentures retained by attachments at the anterior remaining teeth are inserted.
  •   Partial removable dentures retained by clasps are inserted in the reduced dentition with remaining anterior teeth.
  •   Combined fixed and removable dentures retained by telescopic crowns are retained in a situation with anterior remaining teeth.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Final recall after 5 years of follow-up examination or loss of the dentures funktion e.g. by loss of teeth or dentures retention measured by a special device.

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

Secondary Outcome

[---]*

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

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2009/11/01
  •   75
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   25   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Patients with a need for treatment with removable partial dentures retained by telescopic crowns, attachments or clasps who were informed about different therapies and decided to be trated by one of the three possibilities
- telescopic crowns can only be used if the teeth can be prepared in one inserting direction, that has to consider the orrientation of the alveolar bone
- only situations with an anterior dentition are accepted with missing molars or missing morals and premolars in both sides of the treated jaw

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

Exclusion Criteria

- persisting craniomandibular dysfunctions
- massive xerostomia
- handicaps which avoid a minimal oral hygiene
- patients who do not want to accept the follow up examination
- patients older than 75 years
- patients younger than 25 years
- general anamnestic contraindications: chronical gastroesophageal reflux, bulimia, tuberculosis, hepatitis, therapy using a anticoagulant, immuno supression, alcohol or drug addiction, general medical problems avoiding the planned treatment, general medical problems avoiding a follow up examination for 5 years

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität Bonn Poliklinik für Zahnärztliche Prothetik, Stiftungsproffessur für Oralmedizinische Technologie
    • Welschnonnenstr. 17
    • 53111  Bonn
    • Germany
    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
    • Department of Prosthodontics, Preclinical Education and Dental Materials Science, University of Bonn, Germany
    • Mr.  Dr.  Stefan  Bayer 
    • Welschnonnenstr. 17
    • 53111  Bonn
    • Germany
    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
    • Department of Prosthodontics, Preclinical Education and Dental Materials Science, University of Bonn, Bonn, Germany
    • Mr.  Dr.  Stefan  Bayer 
    • Welschnonnenstr. 17
    • 53111  Bonn
    • 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
    • Universität Bonn Poliklinik für Zahnärztliche Prothetik, Stiftungsproffessur für Oralmedizinische Technologie
    • Welschnonnenstr. 17
    • 53111  Bonn
    • Germany
    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 suspended on temporary hold
  •   [---]*
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.