No registrations found.
ID
Source
Brief title
Health condition
Edentulous patients with retention and stability problems of conventional upper denture
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peri-implant bone level changes in 10 years
Secondary outcome
Implant survival, restoration survival, clinical parameters, patient satisfaction
Background summary
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.
Study objective
Simular outcomes in patients with 4 implants compared with patients with 6 implants with respects to peri-implant bone level stability
Study design
10-years follow-up evaluation
Intervention
Collecting 10-years follow-up data
Inclusion criteria
- 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.
Exclusion criteria
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.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9729 |
| Other | METC UMCG : M18.224571 (Metc 2018/067) |