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The aim of the present prospective study was to investigate after a 2-year of follow-up any influence of the surgical technique, manual or digitally guided, on peri-implant marginal bone levels stability in implants placed 1 mm sub-crestally.
Patients were treated by means of platform-switched implants provided with a 5 degrees internal conical connection and supporting single screw-retained fixed crowns. Marginal bone level (MBL) measured at prosthesis installation (t0) at 1 (t1), 2 (t2) and at 3 years of follow-up visit (t3) were considered. MBL change from t0 to t3 was investigated. The distance between the implant neck and the first radiographically detected bone to implant contact was considered to evaluate the bone loss. Two groups were considered: Test Group (GD) for implant sites treated with a digitally guided surgery procedure. Control Group (FH) for implants surgically placed without digitally guided surgery, respectively. All the procedures were performed by an experienced operator. Additionally, for both groups MBL changes were correlated to different supra-crestal soft tissue height (STH) amounts: less than 3 and ≥ 3 millimeters, respectively. Peri-implant soft tissue parameters such as probing depth (PPD), modified Sulcus Bleeding Index (mBI) and modified Plaque Index (mPI), were assessed for all the restorations included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group (GD) | Experimental | in this group were considered implant sites treated with a digitally guided surgery procedure |
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| Control Group (FH) | Active Comparator | in this group were considered implant sites treated without a digitally guided surgery procedure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant placement | Procedure | Implants were placed by means of a template for a guided surgery approach (GD Group) or with a standard free-hand surgical approach without any additional device (FH Group). A non expert doctor (less that 20 implants placed in the professional activity) was selected for the procedures related to the GD Group; a skilled operator (more than 1000 implants placed in the professional activity) was selected for the procedures related to the FH Group, respectively. A two-stage surgical technique was chosen. Implants were placed (Anyridge, Megagen Implants, Seoul, Korea) 1 mm below the crestal level, as recommended by the manufacturer. After flap elevation the height of the supra-crestal soft tissue (STH) was measured by means of a calibrated probe. An inter-implant distance of 3 mm at least, and/or an interproximal space from 1.5 to 3 mm between an implant and the adjacent tooth were observed. Flaps were sutured over the implants to allow a submerged healing. |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal bone loss | Measurements were made at mesial and distal aspect of each implant and were reported in millimeters. Because of implants were sub-crestally positioned, measurements where bone was under the implant to abutment level were classified as negative values. On the contrary, measurements where implant neck was over the bone crest were classified as positive values. Measurements were made at mesial and distal aspect of each implant and were reported in millimeters. Because of implants were sub-crestally positioned, measurements where bone was under the implant to abutment level were classified as negative values. On the contrary, measurements where implant neck was over the bone crest were classified as positive values. | From t0 to t3 (3-years of follow up) |
| Measure | Description | Time Frame |
|---|---|---|
| STH | After flap elevation the height of the supra-crestal soft tissue (STH) was measured by means of a calibrated probe. | During surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugenio ER Romeo, Prof. | Odontostomatologia I, ASST Santi Paolo e Carlo, P.O. S. Paolo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Santi Paolo e Carlo | Milan | MI | 20142 | Italy |
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