Plain English Summary
Background and study aims
The treatment of patients with a reduced number of teeth is an important part of daily practice. There are several treatment options. Double-crown-retained dentures (DCRDs) have a natural appearance and as a result, these dentures are very popular. Additionally, most of patients with DCRDs report a high level of chewing comfort due to very high prosthesis retention. DCRDs also permit the inclusion of existing teeth and implants. Studies already shown improvement in oral health and quality of life for patients using DCRDs.
However the manufacturing process of these dentures is not consistent. DCRDs are composed of a primary crown attached in patients mouth and a secondary crown located in the denture. There are different shapes of primary crowns, including conical and cylindrical. Prosthesis retention is provided by the friction between the primary crown (patients mouth) and secondary crowns (denture). However, a need for friction adjustments or even a loss of retention has often been described. As a result, patients can have problems handling these dentures. The Weigl protocol describes a manufacturing process for these dentures using an all-ceramic primary crown and an electroplated secondary crown, which helps to reduce changes in retention during the lifetime of the denture. The aim of this study is to verify the survival rates, complications and maintenance needs of DCRDs manufactured according to the Weigl protocol.
Who can participate?
Anyone who received DCRDs according to the Weigl protocol at the Department of Prosthodontics of the University of Frankfurt am Main, Germany between June 1998 and December 2013
What does the study involve?
There is no direct involvement of participants in this study, as their patient sheets are used for assessment of survival rates, complications and maintenance needs.
What are the benefits and risks of participating?
There are no direct benefits or risks of participating in this study as it does not require direct participant involvement. The results of this study may benefit future patients requiring DCRDs as it may improve success rates and reduce the number of complications.
Where is the study run from?
ZZMK (Carolinum), Goethe University Frankfurt (Germany)
When is the study starting and how long is it expected to run for?
January 2013 to June 2017
Who is funding the study?
Self-funded
Who is the main contact?
Dr. Silvia Brandt
hajjaj@med.uni-frankfurt.de
Trial website
Contact information
Type
Scientific
Primary contact
Dr Silvia Brandt
ORCID ID
http://orcid.org/0000-0001-5530-0412
Contact details
Theodor-Stern-Kai 7
Frankfurt
60596
Germany
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
177/13
Study information
Scientific title
Long-term clinical success of conical electroplated double-crown-retained dentures on implants or natural abutments up to 11.5 years: a retrospective study
Acronym
Study hypothesis
Dentures created with the conical electroplating concept is an alternative to other approaches, especially for combined tooth/implant-supported dentures.
Ethics approval
Ethics Committee of University Frankfurt, 13/05/2013, reference 177/13
Study design
Observational retrospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Reduced dentition in upper and lower jaw
Intervention
For data collection, the sheets of patients who received double-crown-retained dentures (DCRDs) between June 1998 and December 2013 were evaluated for failure of DCRDs, necessary repairs, pressure source, occlusal adjustments, problems with denture removal, relining needs and maintenance needs related to the denture abutments.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Failure of DCRDs (defined as the loss of the denture), evaluated by reviewing patient notes
Secondary outcome measures
The following were evaluated by reviewing patient notes from patients between June 2013 and December 2013:
1. Necessary repairs to dentures
2. Pressure source
3. Occlusal adjustments
4. Problems with denture removal
5. Relining needs
6. Maintenance needs related to the denture abutments
Overall trial start date
01/01/2013
Overall trial end date
15/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Dentures fabricated according to the Weigl protocol
2. Regular ttendance of follow-up exams
3. Tooth-supported DCRDs
4. Implant-supported DCRDs
5. Combined tooth/implant-supported DCRDs
6. Conical implant/abutment connections
7. Aged 18-91 years
Participant type
Patient
Age group
All
Gender
Both
Target number of participants
100
Participant exclusion criteria
Not treated according to the Weigl protocol
Recruitment start date
15/06/2013
Recruitment end date
15/12/2013
Locations
Countries of recruitment
Germany
Trial participating centre
ZZMK (Carolinum) , Goethe University Frankfurt
Theodor-Stern-Kai 7
Frankfurtam Main
60596
Germany
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in Clinical Implant Dentistry and Related Research
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to data protection regulations
Intention to publish date
10/11/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list