Dental Implants,Peri-implantitis,SmokingNCT03766022
Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Clinical Trial
A study testing Neo dental implant Alpha Bio Tec. Ltd. in people with Dental Implants,Peri-implantitis,Smoking, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants,Peri-implantitis,Smoking
- What is being tested?
- Neo dental implant Alpha Bio Tec. Ltd.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Jan 2019to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Dental Implants,Peri-implantitis,Smoking
- Being tested
- Neo dental implant Alpha Bio Tec. Ltd.
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo dental implant Alpha Bio Tec. Ltd.Device
Neo dental implant is used to restore missing teeth
| Study group | Role | What they receive |
|---|---|---|
| Heavy smoker patients | Experimental | Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd. Receives: Device: Neo dental implant Alpha Bio Tec. Ltd. |
| non Smokers patients | Active comparator | Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd. Receives: Device: Neo dental implant Alpha Bio Tec. Ltd. |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal bone loss
Standardized periapical radiographs will be used to assess changes in radiographic bone height.
Measured: 6 months and 18 months after implantation.
Secondary outcomes (3)
Implants probing depth (IPD)
will be measured by inserting a probe to the gingival pocket at six sites around implant
Measured: 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
Measured: 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.
Measured: 4 months, 6 months and 16 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start22 Jan 2019
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implants,Peri-implantitis,SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hadar Zigdon, DMD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766022
- Sponsor's protocol ID
- CTIL-0418-18-RMB
- Status last verified
- Aug 2025
- First submitted
- 20 Nov 2018
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03766022
- Acronym / sponsor ID
- CTIL-0418-18-RMB
- Conditions
- Dental Implants,Peri-implantitis,Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy smoker patients | Experimental | Device: Neo dental implant Alpha Bio Tec. Ltd.Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd. |
| non Smokers patients | Active comparator | Device: Neo dental implant Alpha Bio Tec. Ltd.Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neo dental implant Alpha Bio Tec. Ltd.Neo dental implant is used to restore missing teeth | Device | Heavy smoker patients, non Smokers patients |
Primary outcome
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.
3 secondary outcomes
Implants probing depth (IPD)
Time frame: 4 months, 6 months and 16 months after implantation
Bleeding on probing
Time frame: 4 months, 6 months and 16 months after implantation
Labial gingival recession
Time frame: 4 months, 6 months and 16 months after implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadar Zigdon, DMD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neo dental implant Alpha Bio Tec. Ltd. in people with Dental Implants,Peri-implantitis,Smoking, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marginal bone loss (time frame: 6 months and 18 months after implantation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.