Dental Implants,Peri-implantitis,Smoking
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICENeo dental implant Alpha Bio Tec. Ltd.
Neo dental implant is used to restore missing teeth
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age between 20 - 85 years. 2. Written informed consent. 3. In need for a dental implant Adequate alveolar bone Intended to be restored with individual crowns. 4. Heavy smokers (20 Cig/d \> 5years) or non / former smokers (\> 5 years since cessation).
Exclusion criteria
1. Active periodontal disease. 2. Systemic condition and medication that may affect soft and hard tissue. 3. healing Parafunctional occlusal scheme and habits. 4. Pregnancy or intention to become pregnant in the following twelve months. 5. Patient not willing or able to meet the study schedule. 6. Patient in need for simultaneous bone graft or GBR using a membrane barrier.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| marginal bone loss | 6 months and 18 months after implantation. | Standardized periapical radiographs will be used to assess changes in radiographic bone height. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implants probing depth (IPD) | 4 months, 6 months and 16 months after implantation | will be measured by inserting a probe to the gingival pocket at six sites around implant |
| Bleeding on probing | 4 months, 6 months and 16 months after implantation | will be measured by inserting a probe to the gingival pocket at six sites around each implant: Dichotomic measurments: Yes/No |
| Labial gingival recession | 4 months, 6 months and 16 months after implantation | will be measured using the incisal edge. occlusal plan as a fixed reference point. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Implant stability | Immediatly after implant installation (day 0) and 4 months after implantation | Osstel measurements |
Countries
Israel
Outcome results
None listed