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The Aim of this study randomized prospective clinical trial is to examine and compare periimplant tissue changes between heavy smokers and non-smokers at 12 months post loading using the alpha Bio Neo standard diameter implants with conical abutment.
Peri-implant marginal bone level is one of the most important references criteria to monitor peri-implant health.A radiographically measured marginal bone loss of up to 1.5 mm during the first year of loading, followed by a marginal bone loss of up to 0.2 mm for each succeeding year, is an acceptable criterion to determine implant success.
Smoking has been implicated in many adverse systemic outcomes, including tooth loss, alveolar bone loss and dental implant failure.
Platform switching, also known as platform shifting, is whenever an abutment is used that is smaller in diameter than the implant platform. Platform switching can help prevent crestal bone loss.
The hypothesis of the present study is that the use of conical abutment might reduce marginal bone loss around dental implants in both smokers and non-smokers alike.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heavy smoker patients | Experimental | Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd. |
|
| non Smokers patients | Active Comparator | Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neo dental implant Alpha Bio Tec. Ltd. | Device | Neo dental implant is used to restore missing teeth |
|
| Measure | Description | Time Frame |
|---|---|---|
| marginal bone loss | Standardized periapical radiographs will be used to assess changes in radiographic bone height. | 6 months and 18 months after implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Implants probing depth (IPD) | will be measured by inserting a probe to the gingival pocket at six sites around implant | 4 months, 6 months and 16 months after implantation |
| Bleeding on probing |
| Measure | Description | Time Frame |
|---|---|---|
| Implant stability | Osstel measurements | Immediatly after implant installation (day 0) and 4 months after implantation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadar Zigdon, DMD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Hospital | Haifa | Israel |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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will be measured by inserting a probe to the gingival pocket at six sites around each implant: Dichotomic measurments: Yes/No
| 4 months, 6 months and 16 months after implantation |
| Labial gingival recession | will be measured using the incisal edge. occlusal plan as a fixed reference point. | 4 months, 6 months and 16 months after implantation |