Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Clinical Trial
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2018
CompletedFirst Posted
Study publicly available on registry
December 5, 2018
CompletedStudy Start
First participant enrolled
January 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2024
CompletedAugust 17, 2025
August 1, 2025
5.1 years
November 20, 2018
August 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
marginal bone loss
Standardized periapical radiographs will be used to assess changes in radiographic bone height.
6 months and 18 months after implantation.
Secondary Outcomes (3)
Implants probing depth (IPD)
4 months, 6 months and 16 months after implantation
Bleeding on probing
4 months, 6 months and 16 months after implantation
Labial gingival recession
4 months, 6 months and 16 months after implantation
Other Outcomes (1)
Implant stability
Immediatly after implant installation (day 0) and 4 months after implantation
Study Arms (2)
Heavy smoker patients
EXPERIMENTALMarginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd.
non Smokers patients
ACTIVE COMPARATORMarginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd.
Interventions
Neo dental implant is used to restore missing teeth
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rambam Hospital
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hadar Zigdon, DMD
Rambam Health Care Campus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2018
First Posted
December 5, 2018
Study Start
January 22, 2019
Primary Completion
February 29, 2024
Study Completion
February 29, 2024
Last Updated
August 17, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share