Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Clinical Trial

Study 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.

Official Title
-----------------
Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Controlled Clinical Trial

Conditions
-----------------
Dental Implants,Peri-implantitis,Smoking

Intervention / Treatment
-----------------
* Device: Neo dental implant Alpha Bio Tec. Ltd.


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heavy smoker patients<br>Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd. | Device: Neo dental implant Alpha Bio Tec. Ltd.<br>* Neo dental implant is used to restore missing teeth<br>|
| Active Comparator: non Smokers patients<br>Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd. | Device: Neo dental implant Alpha Bio Tec. Ltd.<br>* Neo dental implant is used to restore missing teeth<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |