Dental ImplantNCT03018457
Evaluation of Trabecular Microarchitecture of the Alveolar Bone by Micro-computed Tomography and of Osseointegration of Dental Implants by Resonance Frequency Analysis
An observational study of Dental Implant, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Dental implants are a prosthetic rehabilitation device whose success depends of the bone morphology and quality, in more the surgical procedure. This study aims to assess whether the parameters of the trabecular microarchitecture of alveolar bone taken from the site of the placement of the dental implant, calculated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant
- What is being tested?
- ISQ
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2017to 4 May 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who need a dental implant
Who may be able to join
- affiliated patient or entitled to a social security scheme
- requiring the installation of one or more dental implants
- partial or total loss teeth, the height and width od the alveolar bone does not require bone grafting or guides regeneration
Who cannot join
- patient who underwent pre-implant surgery (bone grafting, elevation of the maxillary sinus, guided regeneration)
- patient under corticosteroid therapy in the long term
- patient who benefited from the head and neck radiotherapy
- patient under bisphosphonates intravenously treatment
- all cases immediate implantation and extraction of all implant put into immediate expenses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Trabecular Microarchitecture of the Alveolar Bone by Micro-computed Tomography and of Osseointegration of Dental Implants by Resonance Frequency Analysis: Correlation Study.
Dental implants are a prosthetic rehabilitation device whose success depends of the bone morphology and quality, in more the surgical procedure.
This study aims to assess whether the parameters of the trabecular microarchitecture of alveolar bone taken from the site of the placement of the dental implant, calculated by micro-CT are correlated with ISQ (implant stability quotient) using the Osstell according the principle of the resonance frequency analysis at the 10th postoperative week during the osseointegration of dental implants (secondary stability).
The cortical alveolar bone is a recognized factor in the phase of primary stability of osseointegration. The role of trabecular bone in the secondary stability is not clearly determined.
Read the detailed description
The aim of this study is to check whether the trabecular bone with its microarchitecture plays a predictive role in osseointegration of dental implants precisely in its biological stability phase or its secondary stability phase.
If this correlation is established, a larger study must be conducted to identify a profile of patients at risk for failure of osseointegration of the dental implant.
- Conditions
- Dental Implant
- Being tested
- ISQ
- Keywords
- Trabecular microarchitecture, alveolar bone, osseointegration, dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISQDevice
Measured by Osstell.
| Study group | Role | What they receive |
|---|---|---|
| patients who need a dental implants | Not described Receives: Device: ISQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Stability Quotient (ISQ)
The Osstell is a portable hand instrument used to measure the stability of the dental implant according to the principle of the resonance frequency analysis. It is allow to measure the ISQ.
Measured: 10 weeks
Secondary outcomes (9)
volume fraction of the bone
Measured by Scanco microscanner
Measured: 10 weeks
thickness between trabecular
Measured by Scanco microscanner
Measured: 10 weeks
Thickness of trabecular
Measured by Scanco microscanner
Measured: 10 weeks
trabecular separation
Measured by Scanco microscanner
Measured: 10 weeks
trabecular number
Measured by Scanco microscanner
Measured: 10 weeks
structural model index
Measured by Scanco microscanner
Measured: 10 weeks
trabecular pattern factor
Measured by Scanco microscanner
Measured: 10 weeks
connectivity density
Measured by Scanco microscanner
Measured: 10 weeks
degree of anisotropy
Measured by Scanco microscanner
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start5 May 2017
- Primary completion4 May 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry THOMAS, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018457
- Sponsor's protocol ID
- 1608111
- Other IDs
- ANSM
- Status last verified
- Feb 2018
- First submitted
- 10 Jan 2017
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Trabecular Microarchitecture of the Alveolar Bone by Micro-computed Tomography and of Osseointegration of Dental Implants by Resonance Frequency Analysis: Correlation Study.
- ClinicalTrials.gov ID
- NCT03018457
- Acronym / sponsor ID
- 1608111
- Conditions
- Dental Implant
- Keywords
- Trabecular microarchitecture, alveolar bone, osseointegration, dental implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 12 Jan 2017 (estimated)
- 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.
Dental implants are a prosthetic rehabilitation device whose success depends of the bone morphology and quality, in more the surgical procedure.
This study aims to assess whether the parameters of the trabecular microarchitecture of alveolar bone taken from the site of the placement of the dental implant, calculated by micro-CT are correlated with ISQ (implant stability quotient) using the Osstell according the principle of the resonance frequency analysis at the 10th postoperative week during the osseointegration of dental implants (secondary stability).
The cortical alveolar bone is a recognized factor in the phase of primary stability of osseointegration. The role of trabecular bone in the secondary stability is not clearly determined.
Detailed description
The aim of this study is to check whether the trabecular bone with its microarchitecture plays a predictive role in osseointegration of dental implants precisely in its biological stability phase or its secondary stability phase.
If this correlation is established, a larger study must be conducted to identify a profile of patients at risk for failure of osseointegration of the dental implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who need a dental implants | – | Device: ISQ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who need a dental implant
Key inclusion criteria (3 listed)
- affiliated patient or entitled to a social security scheme
- requiring the installation of one or more dental implants
- partial or total loss teeth, the height and width od the alveolar bone does not require bone grafting or guides regeneration
Key exclusion criteria (5 listed)
- patient who underwent pre-implant surgery (bone grafting, elevation of the maxillary sinus, guided regeneration)
- patient under corticosteroid therapy in the long term
- patient who benefited from the head and neck radiotherapy
- patient under bisphosphonates intravenously treatment
- all cases immediate implantation and extraction of all implant put into immediate expenses
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 |
|---|---|---|
| ISQMeasured by Osstell. | Device | patients who need a dental implants |
Primary outcome
Implant Stability Quotient (ISQ)
Time frame: 10 weeks
The Osstell is a portable hand instrument used to measure the stability of the dental implant according to the principle of the resonance frequency analysis. It is allow to measure the ISQ.
9 secondary outcomes
volume fraction of the bone
Time frame: 10 weeks
thickness between trabecular
Time frame: 10 weeks
Thickness of trabecular
Time frame: 10 weeks
trabecular separation
Time frame: 10 weeks
trabecular number
Time frame: 10 weeks
structural model index
Time frame: 10 weeks
trabecular pattern factor
Time frame: 10 weeks
connectivity density
Time frame: 10 weeks
degree of anisotropy
Time frame: 10 weeks
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 21 May 2018.
- Individual participant dataSharing planned: No
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Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
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L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
RecruitingObservational study
Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants
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Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
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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.
Thierry THOMAS, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Dental Implant, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 5 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 21 May 2018. 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 France. 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?
Implant Stability Quotient (ISQ) (time frame: 10 weeks). 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 21 May 2018.