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CompletedNCT03766022Updated Aug 17, 2025

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

An interventional study of Neo dental implant Alpha Bio Tec. Ltd. in Dental Implants,Peri-implantitis,Smoking, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged 20 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-17.

Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dental Implants,Peri-implantitis,Smoking

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03

In context

Smoking

268 studies on the registry are indexed under Smoking; 136 are open to participants now.

This study's enrollment of 32 is below the median of 120 across 211 interventional studies indexed under Smoking.

Browse Smoking studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
32 participants (actual)

Study arms

  • 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.

  • 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.

Interventions

  • DeviceNeo dental implant Alpha Bio Tec. Ltd.

    Neo dental implant is used to restore missing teeth

06

What researchers measure

Primary outcomes

  1. marginal bone loss

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

    Time frame: 6 months and 18 months after implantation.

Secondary outcomes

  1. Implants probing depth (IPD)

    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

  2. Bleeding on probing

    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

  3. Labial gingival recession

    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 outcomes

  1. Implant stability

    Osstel measurements

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

07

Study locations

1 site
  • Rambam Hospital
    Haifa, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03766022
Lead sponsor
Rambam Health Care Campus
Responsible party
Sponsor
First posted
Dec 5, 2018
Start date
Jan 22, 2019
Primary completion
Feb 29, 2024
Completion
Feb 29, 2024
Last update
Aug 17, 2025

Study contacts

Hadar Zigdon, DMD
principal investigator · Rambam Health Care Campus

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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