An overdenture supported by two implants doesn't show more peri-implant bone loss after one year than an overdenture supported by four implants.
ID
Bron
Aandoening
Overdenture, Maxilla, Implant
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Peri-implant bone height changes.
Achtergrond van het onderzoek
Background
A numer of edentulous patïents experience problems with a conventional complete upper denture. Lack of retention and stability and an increased gagging reflex are the main complaints 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
The aim of the present study is to compare overdentures that are supported by two and four implants, 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 2 implants with a barmesostructure 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, patient satisfaction and overall health impact
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
According to the literature, treating patients with an overdenture in the maxilla on four implants is the standard treatment. Treating patients with two implants gives similar or less risk, because less implants are placed compared to standard treatment.
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.
Doel van het onderzoek
An overdenture supported by two implants doesn't show more peri-implant bone loss after one year than an overdenture supported by four implants.
Onderzoeksopzet
Prospective randomised controlled trial.
Onderzoeksproduct en/of interventie
The testgroup will get 2 implants with a barmesostructure 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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. At least one year edentulous in the upper jaw
2. problems with retention and stability of the conventional complete denture and/or unpleasant feeling due to extended palatal plate of the denture
3. Patient is endentulous in the lower jaw.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. history of preprosthetic surgery in the upper jaw;
2. medical contraindications for surgery;
3. smoking (or isn't willing to give up smoking six weeks before surgery);
4. history of radiotherapy in the head and neck region.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6561 |
| NTR-old | NTR6742 |
| CCMO | NL63532.042.17 |
| OMON | NL-OMON46717 |