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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implants,Peri-implantitis,Smoking
• Intervention / Treatment: Device: Neo dental implant Alpha Bio Tec. Ltd.

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yaniv Mayer, DMD; Phone Number: 9727772983

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Rambam Hospital
    • Contact: Eli Machtei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heavy smoker patients; 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.; Neo dental implant is used to restore missing teeth
Active Comparator: non Smokers patients; 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.; Neo dental implant is used to restore missing teeth

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability	Osstel measurements	Immediatly after implant installation (day 0) and 4 months after implantation

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: CTIL-0418-18-RMB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No