The aim of the study is comparison of two and four dental implants supporting an overdenture in the upper jaw for patients who experience problems with retention and stability of the upper denture.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Het slecht functioneren van een prothese in de bovenkaak
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peri-implant bone height changes
Secondary outcome
Implant survival, overdenture survival, the clinical condition of the
peri-implant mucosa, masticatory efficiency, patient
satisfaction and overall state of health
Background summary
A number of edentulous patients experiences problems with a conventional
complete upper denture. Lack of retention and stability and an increased
gagging reflex is the main complaint of these patients. An overdenture on
endosseous implants gives the opportunity to improve retention and stability of
the prosthesis and reduce the coverage of the palate.
Study objective
The aim of the study is comparison of two and four dental implants supporting
an overdenture in the upper jaw for patients who experience problems with
retention and stability of the upper denture.
Study design
A prospective randomized controlled trial
Intervention
The testgroup will get 2 implants in combination with an overdenture and
barsuprastructure in the maxilla.
The controlgroup will get 4 implants in combination with an overdenture and
barsuprastructure in the maxilla.
Study burden and risks
De standaard behandeling van minimaal vier implantaten wordt vaak uitgevoerd
bij patiënten met klachten aangaande retentie en stabiliteit van de volledige
bovenprothese. De behandeling van twee implantaten levert eenzelfde of minder
risico op, gezien er minder implantaten worden geplaatst dan tijdens de
standaard behandeling.
De patiënten krijgen één extra afspraak, 1 maand na plaatsen van de
overkappingsprothese. Het tweede meetmoment vindt plaats tijdens de standaard
controle, 1 jaar na het plaatsen van de overkappingsprothese. Tijdens deze
bezoeken worden de klinische en radiologische metingen en de kauwtest verricht
en kunnen de vragenlijsten met betrekking tot de patiënt tevredenheid worden
ingevuld.
The standard treatment of a minimum of four implants is performed regularly in
patiënts with complaints of retention and stability of the full arch denture in
the upper jaw. The treatment with two implants results in similar or less risc,
due to the placing of less implants than during standard treatment.
Patients get one extra appointment, one month after placing the overdenture.
The second measurement will take place during standard check-up, one year after
placing the overdenture. During these visits, the clinical and radiological
measurements, the chewing test and questionnaires
regarding patient satisfaction can be completed.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
At least one year edentulous in the upper jaw
problems with retention and stability of the conventional complete denture and/or unpleasant feeling due to extended palatal plate of the denture
Patient is endentulous in the lower jaw
Patient gives written consent for entering the trial
Exclusion criteria
no history of preprosthetic surgery in the upper jaw
no medical contraindications for surgery
patient does not smoke (or is willing to give up smoking six weeks before surgery)
no history of radiotherapy in the head and neck region
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63532.042.17 |
| OMON | NL-OMON21899 |