Dental ImplantsNCT01104363
Splint Versus Non-splint Implant Impressions
A study testing Snow white plaster 2 and Primopattern LC gel + PVS in people with Dental Implants and Dental Impression Materials, run by Hospital San Pietro Fatebenefratelli at 2 sites in Italy.
Trial summary
The purpose of this study is to evaluate the effectiveness of heavy Vinyl PolySiloxane (VPS) and splinted implants impression (Study Group, SG) technique versus plaster implant impression (Control Group, CG) technique, in 12 edentulous patients rehabilitated with the All-on-4/6 concept and Procera® Implant Bridge… Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Dental Impression Materials, Dental Impression Techniques
- What is being tested?
- Snow white plaster 2 and Primopattern LC gel + PVS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesItaly
- Study dates
- Jun 2010to May 2011
- 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 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21 years or older.
- Both genders.
- Fully edentulous patients.
- Both maxilla and mandible.
- Dental implant rehabilitation utilizing the All-on-4 concept at least 8 weeks before impression.
- External hex dental implant.
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- Patients with ability to understand and sign the informed consent prior to starting the study.
- Adequate oral hygiene.
- Immediate functional loading.
- Implant stability quote value =/> 65 from implant placement to final prosthetic rehabilitation.
Who cannot join
- Failure of one or more inclusion criteria.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Marco Tallarico
Rome, RM, 00151
Studio odntoiatrico specialistico dr. Marco Tallarico
Rome, RM, 00151
About this study
Official title: Prosthetic Fit Improving With Splint Implant Impressions: Double-blind, Randomised Clinical Trial of Accuracy and Materials.
The purpose of this study is to evaluate the effectiveness of heavy Vinyl PolySiloxane (VPS) and splinted implants impression (Study Group, SG) technique versus plaster implant impression (Control Group, CG) technique, in 12 edentulous patients rehabilitated with the All-on-4/6 concept and Procera® Implant Bridge (P.I.B.). A longitudinal, double blinded, randomised clinical trial (RCT) was designed to evaluate the accuracy of the impression. All patients were monitored from implant placement until prosthetic loading.
Read the detailed description
The aim of the present study was to investigate the accuracy of pick-up, splinted implants, and heavy VPS impression techniques (Aquasil Putty DECA™ and Aquasil Ultra Light Viscosity (LV) Regular Set, Dentsply International Inc, Caulk, USA); to compare two splint materials for implants: Primopattern LC gel (Primotec, Bad Homburg, Germany), and Smart Dentin Replacement (SDR™, Dentsply International Inc, Caulk, USA); to examine the clinical factors affecting the accuracy of implant impressions; to test the tension-free fit of the new scanner and software NobelProcera™ (NobelBiocare, AB, Göteborg, Sweden) titanium frameworks.The hypothesis to demonstrate is that all impression techniques and used materials reduce time for final restoration and improve the accuracy of the impression.
- Being tested
- Snow white plaster 2, Primopattern LC gel + PVS
- Keywords
- Dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snow white plaster 2Procedure or surgery
Test. Plaster impression not splinted.
Primopattern LC gel + PVSProcedure or surgery
Control PVS impression
| Study group | Role | What they receive |
|---|---|---|
| Snow white Plaster 2 | Experimental | Test Receives: Procedure: Snow white plaster 2 |
| Primopattern LC gel + PVS | Active comparator | Control Receives: Procedure: Primopattern LC gel + PVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant failure
An implant was consid- ered to be a failure if it was lost owing to mobility, implant fracture and/or any infection requiring implant removal.
Measured: Up to 5 years after implant placement
Secondary outcomes (2)
Inter-implants distance between groups
Inter-implants distance between groups assessed both on casts and digital photos measured in mm.
Measured: 4 to 5 months after implant placement (baseline)
Chair-time
Time needed to take impression in both control and test group measured in seconds.
Measured: 4 to 5 months after implant placement (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionMay 2011
Why it stopped: Ethical commentate has not be obtained by the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Pietro Fatebenefratelli
- Sponsor type
- University, hospital or other
- Collaborators
- Nobel Biocare
- Responsible party
- Principal investigator, Marco Tallarico, Hospital San Pietro Fatebenefratelli
- Investigators
- Marco Tallarico, dr., Study director, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104363
- Sponsor's protocol ID
- NobelBiocare-RCT-Procera
- Status last verified
- Aug 2018
- First submitted
- 2 Apr 2010
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee H, So JS, Hochstedler JL, Ercoli C. The accuracy of implant impressions: a systematic review. J Prosthet Dent. 2008 Oct;100(4):285-91. doi: 10.1016/S0022-3913(08)60208-5.
PubMed 18922257
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Fit Improving With Splint Implant Impressions: Double-blind, Randomised Clinical Trial of Accuracy and Materials.
- ClinicalTrials.gov ID
- NCT01104363
- Acronym / sponsor ID
- NobelBiocare-RCT-Procera
- Keywords
- Dental implants
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Ethical commentate has not be obtained by the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital San Pietro FatebenefratelliUniversity, hospital or other
- Collaborators
- Nobel Biocare
- Study start
- Jun 2010 (actual)
- Primary completion
- Sep 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Apr 2010 (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.
The purpose of this study is to evaluate the effectiveness of heavy Vinyl PolySiloxane (VPS) and splinted implants impression (Study Group, SG) technique versus plaster implant impression (Control Group, CG) technique, in 12 edentulous patients rehabilitated with the All-on-4/6 concept and Procera® Implant Bridge (P.I.B.). A longitudinal, double blinded, randomised clinical trial (RCT) was designed to evaluate the accuracy of the impression. All patients were monitored from implant placement until prosthetic loading.
Detailed description
The aim of the present study was to investigate the accuracy of pick-up, splinted implants, and heavy VPS impression techniques (Aquasil Putty DECA™ and Aquasil Ultra Light Viscosity (LV) Regular Set, Dentsply International Inc, Caulk, USA); to compare two splint materials for implants: Primopattern LC gel (Primotec, Bad Homburg, Germany), and Smart Dentin Replacement (SDR™, Dentsply International Inc, Caulk, USA); to examine the clinical factors affecting the accuracy of implant impressions; to test the tension-free fit of the new scanner and software NobelProcera™ (NobelBiocare, AB, Göteborg, Sweden) titanium frameworks.The hypothesis to demonstrate is that all impression techniques and used materials reduce time for final restoration and improve the accuracy of the impression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Snow white Plaster 2 | Experimental | Procedure: Snow white plaster 2Test |
| Primopattern LC gel + PVS | Active comparator | Procedure: Primopattern LC gel + PVSControl |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 21 years or older.
- Both genders.
- Fully edentulous patients.
- Both maxilla and mandible.
- Dental implant rehabilitation utilizing the All-on-4 concept at least 8 weeks before impression.
Key exclusion criteria (1 listed)
- Failure of one or more inclusion criteria.
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 |
|---|---|---|
| Snow white plaster 2Test. Plaster impression not splinted. | Procedure or surgery | Snow white Plaster 2 |
| Primopattern LC gel + PVSControl PVS impression | Procedure or surgery | Primopattern LC gel + PVS |
Primary outcome
Implant failure
Time frame: Up to 5 years after implant placement
An implant was consid- ered to be a failure if it was lost owing to mobility, implant fracture and/or any infection requiring implant removal.
2 secondary outcomes
Inter-implants distance between groups
Time frame: 4 to 5 months after implant placement (baseline)
Chair-time
Time frame: 4 to 5 months after implant placement (baseline)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Background: PubMed 18922257Lee H, So JS, Hochstedler JL, Ercoli C. The accuracy of implant impressions: a systematic review. J Prosthet Dent. 2008 Oct;100(4):285-91. doi: 10.1016/S0022-3913(08)60208-5.
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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.
Marco Tallarico, dr. study director
Private Practice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snow white plaster 2 and Primopattern LC gel + PVS in people with Dental Implants and Dental Impression Materials, run by Hospital San Pietro Fatebenefratelli at 2 sites in Italy.
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 10 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: withdrawn, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 was withdrawn before enrolling participants, so there are no results.
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 failure (time frame: Up to 5 years after implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01104363, which also lists 1 linked publication.
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 Aug 2018.