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This randomized controlled trial aimed to assess the effect of the implant neck design (microthreaded vs. non-microthreaded) as well as the type of abutment connection (internal conical vs. external flat-to-flat) on long-term crestal bone remodelling and peri-implant health. Four implants used for a bar-retained maxillary overdenture, were followed over a period of at least 6 years.
Twenty-five patients were treated with a bar-retained maxillary overdenture. Four different implants were placed, with respectively: internal connection and microthreads on the implant neck (I MT); internal connection, without microthreads (I NMT); external connection, with microthreads (E MT); and external connection, without microthreads (E NMT). Other design features, s.a. diameter, surface topography, extent of platform switch as well as the surgical and prosthetic treatment protocol were identical. Radiographic crestal bone loss (CBL), plaque score (PS), bleeding on probing (Bop) and probing pocket depth (PPD) were determined at 1 and 6 years after implant placement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internal Microthread implant | Active Comparator | Each participant received 4 implants, one of each type |
|
| Internal Non Microthread implant | Experimental |
| |
| External microthread implant | Experimental |
| |
| External Non-Microthread implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant placement | Device | Each patient received 4 implants to support a bar supported overdenture. One implant is commercially available, 3 implants were experimentally made by the manufacturer for this study. The implants were similar in macro-desing, surface and platform shift but differ in microthread design and implant-abutment connection. |
| Measure | Description | Time Frame |
|---|---|---|
| Crestal bone loss | Radiographic measurement of crestal bone loss | The measurements were performed at 1 and 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque | Plaque was measured at 4 sites on each implant | The measurements were performed at 1 and 6 years |
| Probing pocket depth | The measurements were performed at 1 and 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugo De Bruyn | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University | Ghent | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34378860 | Result | Doornewaard R, Sakani S, Matthys C, Glibert M, Bronkhorst E, Vandeweghe S, Vervaeke S, De Bruyn H. Four-implant-supported overdenture treatment in the maxilla. Part I: A randomized controlled split mouth trial assessing the effect of microthreads and abutment connection type on 4 years peri-implant health. Clin Implant Dent Relat Res. 2021 Oct;23(5):671-679. doi: 10.1111/cid.13037. Epub 2021 Aug 11. | |
| 29575488 |
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Split-mouth study
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|
| Bleeding on probing | The measurements were performed at 1 and 6 years |
| Result |
| Glibert M, Vervaeke S, Jacquet W, Vermeersch K, Ostman PO, De Bruyn H. A randomized controlled clinical trial to assess crestal bone remodeling of four different implant designs. Clin Implant Dent Relat Res. 2018 Aug;20(4):455-462. doi: 10.1111/cid.12604. Epub 2018 Mar 25. |
| 40552788 | Derived | Matthijs S, Christiaens V, Matthys C, De Bruyn H, Glibert M. A 6-Year Randomized Controlled Trial on Different Implant Designs in Maxillary Overdenture Patients. Clin Implant Dent Relat Res. 2025 Jun;27(3):e70069. doi: 10.1111/cid.70069. |