Dental ImpactionSTARKIMPLANTNCT03455361
Evaluation of Bone Level Around Stark Conical Screw Implants With V-Blast Surface
An observational study of Dental Impaction, run by University of Milan.
Trial summary
Clinical evaluation of osteointegration of bone level implants (Stark conical screw implants, with V-Blast surface treatment), placed without sufficient primary stability. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Impaction
- What is being tested?
- Stark Implant with low primary stability
- Type of treatment
- Surgery or procedure
- How many people
- 293 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 1 Mar 2017
- 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: the sample is composed by patients who had received Stark bone level V-Blast implants in 4 private offices in Italy. The same surgical protocol was used for all implants and a detailed informed consent was obtained from all patients, and included in their respective charts. For the study objective were enrolled patient who didn't achieved primary stability at the placement: 26 patient
Who may be able to join
- patient who had received Stark bone level V-Blast implants in 4 private offices in Italy
- patient subscribed a detailed informed consent
- same surgical protocol was applied
Who cannot join
- patient without Stark implant
About this study
Official title: Clinical Osteointegration of Bone Level Implants With Conical Shape and Textured Surface With Low Primary Stability
Clinical evaluation of osteointegration of bone level implants (Stark conical screw implants, with V-Blast surface treatment), placed without sufficient primary stability.
Read the detailed description
26 Implants were placed with a unique operative protocol in 4 private offices. A detailed informed consent was obtained from all patients. Surgical guides were used to achieve the idea implant position and axis.
Osteotomy drills were used in the sequence recommended by the implant manufacturer. Bone type was assessed by CT examinations using the classification proposed by Rebaudi.
All implants were tested by applying a lateral mild load with a probe in order to verify mobility immediately after placement.
Parameter used to assess a low primary stability were:
- insertion torque lower than 10 N / cm
- slight mobility of implant upon application of lateral load of 250 g After surgery, patients were instructed not to chew or to wear their removable dentures in the treated areas.
Follow-up post-operative visits were scheduled at 1 and 4 weeks. At 4-6 months after placement a periapical radiograph was taken, a torque/countertorque test of 30 Ncm was conducted and osteointegrated implants were restored. Patients were recalled, examined, and periapical radiographs were taken for a minimum of 6 months.
- Conditions
- Dental Impaction
- Being tested
- Stark Implant with low primary stability
- Keywords
- implant stability, dental implants, primary stability
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stark Implant with low primary stabilityProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Stark Implant with low primary stability | Patient who had received bone level V-Blast implants with low primary stability. Receives: Procedure: Stark Implant with low primary stability | |
| Stark Implant with primary stability | Patient who had received bone level V-Blast implants and achieved primary stability. Receives: Procedure: Stark Implant with low primary stability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteointegration of V-Blast surface implant with low primary stability (<10 N/cm) after 4-6 months
After 4-6 months, implant without good primary stability were evaluatd. A periapical radiograph was taken, a torque/countertorque test of 30 Ncm was conducted and osteointegrated implants were restored.
Measured: 4 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start1 Mar 2016
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImpactionStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulio Rasperini, University of Milan
- Investigators
- Giulio Rasperini, Prof., Study director, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455361
- Sponsor's protocol ID
- StarkImplant
- Acronym
- STARKIMPLANT
- Status last verified
- Mar 2018
- First submitted
- 16 Feb 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Osteointegration of Bone Level Implants With Conical Shape and Textured Surface With Low Primary Stability
- ClinicalTrials.gov ID
- NCT03455361
- Acronym / sponsor ID
- STARKIMPLANT / StarkImplant
- Conditions
- Dental Impaction
- Keywords
- implant stability, dental implants, primary stability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 6 Mar 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.
Clinical evaluation of osteointegration of bone level implants (Stark conical screw implants, with V-Blast surface treatment), placed without sufficient primary stability.
Detailed description
26 Implants were placed with a unique operative protocol in 4 private offices. A detailed informed consent was obtained from all patients. Surgical guides were used to achieve the idea implant position and axis.
Osteotomy drills were used in the sequence recommended by the implant manufacturer. Bone type was assessed by CT examinations using the classification proposed by Rebaudi.
All implants were tested by applying a lateral mild load with a probe in order to verify mobility immediately after placement.
Parameter used to assess a low primary stability were:
- insertion torque lower than 10 N / cm
- slight mobility of implant upon application of lateral load of 250 g After surgery, patients were instructed not to chew or to wear their removable dentures in the treated areas.
Follow-up post-operative visits were scheduled at 1 and 4 weeks. At 4-6 months after placement a periapical radiograph was taken, a torque/countertorque test of 30 Ncm was conducted and osteointegrated implants were restored. Patients were recalled, examined, and periapical radiographs were taken for a minimum of 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stark Implant with low primary stability | – | Procedure: Stark Implant with low primary stabilityPatient who had received bone level V-Blast implants with low primary stability. |
| Stark Implant with primary stability | – | Procedure: Stark Implant with low primary stabilityPatient who had received bone level V-Blast implants and achieved primary stability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the sample is composed by patients who had received Stark bone level V-Blast implants in 4 private offices in Italy. The same surgical protocol was used for all implants and a detailed informed consent was obtained from all patients, and included in their respective charts. For the study objective were enrolled patient who didn't achieved primary stability at the placement: 26 patient
Key inclusion criteria (3 listed)
- patient who had received Stark bone level V-Blast implants in 4 private offices in Italy
- patient subscribed a detailed informed consent
- same surgical protocol was applied
Key exclusion criteria (1 listed)
- patient without Stark implant
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 |
|---|---|---|
| Stark Implant with low primary stability | Procedure or surgery | Stark Implant with low primary stability, Stark Implant with primary stability |
Primary outcome
Osteointegration of V-Blast surface implant with low primary stability (<10 N/cm) after 4-6 months
Time frame: 4 to 6 months
After 4-6 months, implant without good primary stability were evaluatd. A periapical radiograph was taken, a torque/countertorque test of 30 Ncm was conducted and osteointegrated implants were restored.
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 29 Mar 2018.
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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.
Giulio Rasperini, Prof. study director
University of Milan
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Impaction, run by University of Milan.
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 1 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 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Osteointegration of V-Blast surface implant with low primary stability (<10 N/cm) after 4-6 months (time frame: 4 to 6 months). 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 29 Mar 2018.