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• Introduction and rationale Patients experiencing problems with their conventional maxillary denture can benefit from implant-retained overdentures (IODs). Several retention systems are available. These retention systems can be roughly divided into bar-retained IODs, in which multiple implants are splinted and the overdenture is attached through retentive clips, and into retention systems using non-splinted solitary attachments. Bar-retained IOD's provide good retention, require little maintenance, but are more expensive than solitary attachments. Medium term results of bar-retained IODs are promising with high implant and overdenture survival and low incidence of complications and may be considered the gold standard. Solitary attachments serve as an alternative to bars. These attachments are more economical and are easy to clean by the patient, but wear more easily, which can cause lack of retention. However, replacement of these attachments can often be done chair side. A recent review reported that, when a maxillary IOD is supported by four implants, both types show equal implant survival, overdenture survival and patient satisfaction. However, these conclusions are based on a limited amount of randomized controlled trials. Moreover, most studies reporting on solitary attachments were retrospective. Evidence on maxillary IOD attachment systems has been mostly short to medium term, non-comparing or retrospective and therefore inconclusive. This underlines the need for studies comparing different attachment systems with a longer follow-up.
The study design is an observational study to compare treatment outcomes of fully edentulous patients with maxillary IODs, supported by four implants, retained by either bars or Locators. Patients were treated 10 years ago with dental implants and an overdenture in the maxilla because of problems with retention and stability with their conventional denture. Outcomes: primary outcome is the change in marginal peri-implant bone level 10 years after placing the overdenture. Secondary outcome measures will be implant and overdenture survival, peri-implant mucosa health and patients' satisfaction using a questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maxilillary implant overdenture retained by bars | Active Comparator | Patients treated with 4 dental implants in the edentulous maxilla and an overdenture retained by bars |
|
| Maxilillary implant overdenture retained by Locators | Active Comparator | Patients treated with 4 dental implants in the edentulous maxilla and an overdenture retained by solitary abutments (Locators) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maxillary implant overdenture | Device | Patients with an edentulous maxilla and problems with their conventional denture are treated with an implant overdenture either retained by bars or Locators |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peri-implant marginal bone level | Difference in peri-implant bone level between start of functional period and at 10 years evaluation period | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival | Percentage of number of initially placed implants still in place after 10 years | 10 years |
| Overdenture survival | Percentage of number of initially placed overdentures still in place after 10 years |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria at the time of treatment:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henny Meijer, Prof. dr. | Contact | +31503613840 | h.j.a.meijer@umcg.nl | |
| Gerry Raghoebar, Prof. dr. | Contact | +31503613840 | g.m.raghoebar@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Henny Meijer, Prof. dr. | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Oral and Maxillofacial Surgery UMCG | Groningen | 9713GZ | Netherlands |
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| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
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Prospective comparative study
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| 10 years |
| Pocket probing depth | Depth in millimeter of probing in the peri-implant sulcus | at 10 years |
| Plaque score | Amount of plaque on implant abutment scored with the Modified Plaque Index, score 0-3, 3 is the worst | at 10 years |
| Peri-implant mucosa condition | Health of peri-implant mucosa scored wit a Gingiva Index, score 0-3, 3 is the worst | at 10 years |
| Patient satisfaction | Satisfaction of patients scored with a 5-point Likert scale, score 1-5, 5 is most dissatisfied | at 10 years |
| D009059 |
| Mouth Diseases |
| D014076 | Tooth Diseases |