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

Not Applicable

Recruiting

• Conditions: Dental Implants,Peri-implantitis,Smoking
• Interventions: Device: Neo dental implant Alpha Bio Tec. Ltd.

• Registration Number: NCT03766022
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-05
• Study Start: 2019-01-22
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-02
• Last Update Posted: 2023-04-04
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non Smokers patients	Neo dental implant Alpha Bio Tec. Ltd.	Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd.
Heavy smoker patients	Neo dental implant Alpha Bio Tec. Ltd.	Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd.

Primary Outcome Measures

Name	Time	Method
marginal bone loss	6 months and 18 months after implantation.	Standardized periapical radiographs will be used to assess changes in radiographic bone height.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Rambam Hospital; 🇮🇱 Haifa, Israel