No registrations found.
ID
Source
Health condition
Overdenture, maxilla, locator, bar
Overkappingsprothese, bovenkaak, locator, staaf
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peri-implant bone height changes.
Secondary outcome
1. Implant survival;
2. Overdenture survival;
3. The clinical condition of the peri-implant mucosa;
4. Masticatory efficiency and patient satisfaction.
Background summary
Background of the study:
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.
Objective of the study:
The aim of the study is comparison of two attachment systems with four dental implants and overdentures in the upper jaw for patients who
experience problems with retention and stability of the upper denture.
Study design:
A prospective randomized controlled trial.
Study population:
Healthy persons aged 18 years or older.
Intervention:
The testgroup will get 4 implants with a ballmesostructure in combination with an overdenture in the maxilla. The controlgroup will get 4
implants with a barmesostructure in combination with an overdenture in the maxilla.
Primary study parameters/outcome of the study:
Peri-implant bone height changes.
Secundary study parameters/outcome of the study:
Implant survival, overdenture survival, the clinical condition of the peri-implant mucosa, masticatory efficiency and patient satisfaction.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
According to the literature, both treatmenst are common treatments for patients with complaints of retention and stability of the upper
denture. So there is no additional risk for the patients participating in the study. The patients will get to additional appointments for check-up.
The first 1 month after placement of the overdenture and the second 1 year after placement of the overdenture. During these visits, the
clinical and radiological measurements, the chewing test and questionnaires regarding patient satisfaction can be completed.
Study objective
A ball mesostrucure is easier to clean and will give better results then a bar mesostructure. Also, the technical procedure is easier and will satisfy the clinician and patient more.
Study design
Prospective randomised controlled trial.
Intervention
The testgroup will get 4 implants with a ballmesostructure in combination with an overdenture in the maxilla.
The controlgroup will get 4
implants with a barmesostructure in combination with an overdenture in the maxilla.
Inclusion criteria
At least two years 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.
Exclusion criteria
1. No history of preprosthetic surgery in the upper jaw;
2. No medical contraindications for surgery;
3. Patient does not smoke (or is willing to give up smoking six weeks before surgery);
4. No history of radiotherapy in the head and neck region.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3667 |
| NTR-old | NTR3813 |
| CCMO | NL43293.042.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38882 |