Simular outcomes in patients with 4 implants compared with patients with 6 implants with respects to peri-implant bone level stability
ID
Bron
Verkorte titel
Aandoening
Edentulous patients with retention and stability problems of conventional upper denture
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Peri-implant bone level changes in 10 years
Achtergrond van het onderzoek
Edentulous patients often experience problems with their complete dentures. The increase in comfort for patients wearing an implant-supported overdenture versus a conventional denture is striking, especially for those who suffer from lack of stability and retention. Since results of 6 bar-connected implants and 4 bar-connected seem comparable and with favourable one-year and 5-years results, the question raises whether this premise will hold after a longer evaluation period and whether 6 implants are needed to support an implant-retained maxillary overdenture. Yet, there are no randomized controlled trials of ≥10 years in which the treatment outcome of 4-implant maxillary overdentures are compared with 6-implant maxillary overdentures. Therefore, the purpose of this 10-years randomized controlled trial is to assess the treatment outcome (implant survival, overdenture survival, peri-implant health, radiographic bone height changes, patients’ satisfaction and biological/technical complications) of maxillary overdentures supported by 4 or 6 dental implants in the maxillary region.
Doel van het onderzoek
Simular outcomes in patients with 4 implants compared with patients with 6 implants with respects to peri-implant bone level stability
Onderzoeksopzet
10-years follow-up evaluation
Onderzoeksproduct en/of interventie
Collecting 10-years follow-up data
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- at least 18 years of age;
- capable of understanding and giving informed consent;
- at least one year edentulous in the maxilla and mandible;
- bone dimensions at least 12 mm in height and at least 5 mm in width to reach initial stability of the implant;
- sufficient interocclusal space for a bar-supported attachment system.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Excluded were patients with ASA score ≥III, who were smoking, with a history of radiotherapy in the head and neck region or a history of pre-prosthetic surgery or previous implant placement.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9729 |
| Ander register | METC UMCG : M18.224571 (Metc 2018/067) |