Implant ComplicationNCT04769934
Impact of Implant Insertion Torque on Peri-implant Bone Level.
An observational study of Implant Complication, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial summary
Observational study with one single arm. The purpose of this study was to evaluate the impact of the insertion torque and of the implant stability on the marginal bone level changes for dental implants placed into healed ridges. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Complication
- What is being tested?
- Penguin RFA
- Type of treatment
- Medical device
- How many people
- 93 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2018to 1 Aug 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: partially edentulous patients
Who may be able to join
- All partially edentulous patients requiring simple Implant placement,
- being at least 18-year-old and able to sign an informed consent,
- The patients that will be enrolled must have a bone quantity that allows the placement of regular implants according to the radiographic evaluations (pre-operative radiographic examination).
Who cannot join
- Heavy smokers (more than 10 cigarettes/day).
- Immunosuppressed or immunocompromised patients
- Uncontrolled diabetes
- Active periodontal disease
- Patients with a full mouth marginal bleeding score higher than 20%
- Addiction to alcohol or drugs
Show all 12Show fewer
- Psychiatric problems
- Severe caries, periapical lesions, acute infection (abscess)
- Immediate post-extractive implants (at least 2 months after extraction have to elapse)
- Patients unable to commit to 3-year follow-up.
- Patients treated or under treatment with intravenous amino- bisphosphonates.
- Patients participating to other studies, if the present protocol could not be fully adhered to.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University of Geneva
Geneva
Irena Sailer, Prof. Dr., +41 22 3794050, irena.sailer@unige.ch
About this study
Observational study with one single arm. The purpose of this study was to evaluate the impact of the insertion torque and of the implant stability on the marginal bone level changes for dental implants placed into healed ridges.
Read the detailed description
The primary outcome would be to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform.
The secondary outcomes would be:
- To evaluate the Implant Stability Quotient (ISQ) changes according to the measurements performed with the instrument Penguin RFA
- To evaluate the implant and prosthetic failure rate as well as the implant and prosthetic complication rates
- The patient satisfaction related to the implant treatment
- Conditions
- Implant Complication
- Being tested
- Penguin RFA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penguin RFADevice
to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform.
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic marginal bone level changes around the implant platform
the changes (in mm) of the marginal bone level around the implant platform
Measured: 3 years
Secondary outcomes (1)
Implant Stability Quotient (ISQ) changes
the measurements will be performed with the instrument Penguin RFA
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Aug 2018
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant ComplicationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 93 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irena Sailer, University of Geneva, Switzerland
- Investigators
- Irena Sailer, Prof. Dr., Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769934
- Sponsor's protocol ID
- 2018-00666
- Other IDs
- 2018
- Status last verified
- Feb 2021
- First submitted
- 17 Feb 2021
- Last updated
- 25 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Implant Insertion Torque on Peri-implant Bone Level.
- ClinicalTrials.gov ID
- NCT04769934
- Acronym / sponsor ID
- 2018-00666
- Conditions
- Implant Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 25 Feb 2021 (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.
Observational study with one single arm. The purpose of this study was to evaluate the impact of the insertion torque and of the implant stability on the marginal bone level changes for dental implants placed into healed ridges.
Detailed description
The primary outcome would be to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform.
The secondary outcomes would be:
- To evaluate the Implant Stability Quotient (ISQ) changes according to the measurements performed with the instrument Penguin RFA
- To evaluate the implant and prosthetic failure rate as well as the implant and prosthetic complication rates
- The patient satisfaction related to the implant treatment
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- partially edentulous patients
Key inclusion criteria (3 listed)
- All partially edentulous patients requiring simple Implant placement,
- being at least 18-year-old and able to sign an informed consent,
- The patients that will be enrolled must have a bone quantity that allows the placement of regular implants according to the radiographic evaluations (pre-operative radiographic examination).
Key exclusion criteria (12 listed)
- Heavy smokers (more than 10 cigarettes/day).
- Immunosuppressed or immunocompromised patients
- Uncontrolled diabetes
- Active periodontal disease
- Patients with a full mouth marginal bleeding score higher than 20%
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 |
|---|---|---|
| Penguin RFAto evaluate the peri-implant bone level changes (marginal bone level) around the implant platform. | Device | – |
Primary outcome
radiographic marginal bone level changes around the implant platform
Time frame: 3 years
the changes (in mm) of the marginal bone level around the implant platform
1 secondary outcome
Implant Stability Quotient (ISQ) changes
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
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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.
Irena Sailer, Prof. Dr. principal investigator
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implant Complication, run by University of Geneva, Switzerland at 1 site in Switzerland.
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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 25 Feb 2021. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irena Sailer, Prof. Dr. (+41 22 3794050, irena.sailer@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographic marginal bone level changes around the implant platform (time frame: 3 years). 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 25 Feb 2021.