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

Rambam Health Care Campus

Status: Completed

Conditions: Dental Implants,Peri-implantitis,Smoking

Treatments: Device: Neo dental implant Alpha Bio Tec. Ltd.

Study type: Interventional

Funder types: Other

Identifiers

NCT03766022

CTIL-0418-18-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Heavy smoker patients

Experimental group

Description:

Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd.

Treatment:

Device: Neo dental implant Alpha Bio Tec. Ltd.

non Smokers patients

Active Comparator group

Description:

Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd.

Treatment:

Device: Neo dental implant Alpha Bio Tec. Ltd.