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

Primary Purpose

Dental Implants,Peri-implantitis,Smoking

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Neo dental implant Alpha Bio Tec. Ltd.
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dental Implants,Peri-implantitis,Smoking

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Rambam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Heavy smoker patients

non Smokers patients

Arm Description

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

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

Outcomes

Primary Outcome Measures

marginal bone loss
Standardized periapical radiographs will be used to assess changes in radiographic bone height.

Secondary Outcome Measures

Implants probing depth (IPD)
will be measured by inserting a probe to the gingival pocket at six sites around implant
Bleeding on probing
will be measured by inserting a probe to the gingival pocket at six sites around each implant: Dichotomic measurments: Yes/No
Labial gingival recession
will be measured using the incisal edge. occlusal plan as a fixed reference point.

Full Information

First Posted
November 20, 2018
Last Updated
April 2, 2023
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT03766022
Brief Title
Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Clinical Trial
Official Title
Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implants,Peri-implantitis,Smoking

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heavy smoker patients
Arm Type
Experimental
Arm Description
Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd.
Arm Title
non Smokers patients
Arm Type
Active Comparator
Arm Description
Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd.
Intervention Type
Device
Intervention Name(s)
Neo dental implant Alpha Bio Tec. Ltd.
Intervention Description
Neo dental implant is used to restore missing teeth
Primary Outcome Measure Information:
Title
marginal bone loss
Description
Standardized periapical radiographs will be used to assess changes in radiographic bone height.
Time Frame
6 months and 18 months after implantation.
Secondary Outcome Measure Information:
Title
Implants probing depth (IPD)
Description
will be measured by inserting a probe to the gingival pocket at six sites around implant
Time Frame
4 months, 6 months and 16 months after implantation
Title
Bleeding on probing
Description
will be measured by inserting a probe to the gingival pocket at six sites around each implant: Dichotomic measurments: Yes/No
Time Frame
4 months, 6 months and 16 months after implantation
Title
Labial gingival recession
Description
will be measured using the incisal edge. occlusal plan as a fixed reference point.
Time Frame
4 months, 6 months and 16 months after implantation
Other Pre-specified Outcome Measures:
Title
Implant stability
Description
Osstel measurements
Time Frame
Immediatly after implant installation (day 0) and 4 months after implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadar Zigdon, DMD
Phone
9727772983
Email
h_zigdon@rambam.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yaniv Mayer, DMD
Phone
9727772983
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadar Zigdon, DMD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Hospital
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eli Machtei

12. IPD Sharing Statement

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

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