Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Implants,Peri-implantitis,Smoking
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- marginal bone loss
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age between 20 - 85 years.
- •Written informed consent.
- •In need for a dental implant Adequate alveolar bone Intended to be restored with individual crowns.
- •Heavy smokers (20 Cig/d \> 5years) or non / former smokers (\> 5 years since cessation).
Exclusion Criteria
- •Active periodontal disease.
- •Systemic condition and medication that may affect soft and hard tissue.
- •healing Parafunctional occlusal scheme and habits.
- •Pregnancy or intention to become pregnant in the following twelve months.
- •Patient not willing or able to meet the study schedule.
- •Patient in need for simultaneous bone graft or GBR using a membrane barrier.
Outcomes
Primary Outcomes
marginal bone loss
Time Frame: 6 months and 18 months after implantation.
Standardized periapical radiographs will be used to assess changes in radiographic bone height.
Secondary Outcomes
- Implants probing depth (IPD)(4 months, 6 months and 16 months after implantation)
- Bleeding on probing(4 months, 6 months and 16 months after implantation)
- Labial gingival recession(4 months, 6 months and 16 months after implantation)