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OpenTrials
Completed

NCT Number: NCT03766022

Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective 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.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Hospital

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neo dental implant Alpha Bio Tec. Ltd.

Device

Neo dental implant is used to restore missing teeth

Primary outcomes

  1. marginal bone loss

    Time frame: 6 months and 18 months after implantation.

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

Secondary outcomes

  1. Implants probing depth (IPD)

    Time frame: 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

  2. Bleeding on probing

    Time frame: 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

  3. Labial gingival recession

    Time frame: 4 months, 6 months and 16 months after implantation

    will be measured using the incisal edge. occlusal plan as a fixed reference point.

Other outcomes

  1. Implant stability

    Time frame: Immediatly after implant installation (day 0) and 4 months after implantation

    Osstel measurements

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2018
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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