Bone Atrophy, AlveolarNobelsinusNCT03357692
All-on-Four Implants With Ultrasonic
A study testing all on four implant rehabilitation in people with Bone Atrophy, Alveolar, run by International Piezosurgery Academy at 1 site in Italy.
Trial summary
The objective of this observational study is the radiographic evaluation of marginal bone remodeling after surgical implant insertion in an immediate loading all-on-four technique with trans-sinusal titanium implants, correlating the gingival thickness and the height of the implant prosthetic stump with the proportion… Read more about this study
- Who is it for?
- Ages 19 months and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Atrophy, Alveolar
- What is being tested?
- all on four implant rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 31 Oct 2017to 15 Feb 2020
- 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 19 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- indications for implant insertion into the maxillary upper jaw, based on a careful diagnosis and treatment plan;
- presence of a residual bone crest with a minimum surgical height of 4 mm at the maxillary sinus (bilaterally), and a thickness of at least 6 mm at the two distally programmed implant sites;
- presence of a residual bone crest with a minimum surgical height of 10 mm at the anterior maxilla, and a thickness of at least 6 mm at the mesially programmed implant sites;
- the bone crest should be healed (at least 6 months after the loss / extraction of the corresponding dental element);
- no regenerated bone;
- Plaque index below 25% and bleeding index less than 20%;
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- the buccal length of the adherent gingiva ≥ 4 mm;
- age of the patient> 18 years;
- systemic condition of the compensated patient (American Society of Anesthesiologist score < 2);
- 8) Patients should be able to examine and understand the protocol of study; 9) subscribing to informed consent.
Who cannot join
- not treated diabetes
- cardiovascular disease
- incapability of maintaining a good oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonic Preparation of the Implant Site in the All-on-Four Technique With Trans-sinus Implants
The objective of this observational study is the radiographic evaluation of marginal bone remodeling after surgical implant insertion in an immediate loading all-on-four technique with trans-sinusal titanium implants, correlating the gingival thickness and the height of the implant prosthetic stump with the proportion of the abovementioned marginal bone remodeling.
Read the detailed description
The extent of marginal bone remodeling around the neck of dental implants has been used for many years as a criterion for defining its long-term success.
In fact, the etiology of this Marginal Bone Loss has not yet been well understood, although many theories have been proposed to explain it.
The influence of the thickness of the mucous membrane on marginal bone loss was discussed elsewhere which suggests a protective action for the underlying soft tissue that recreates a kind of "biological amplitude" around the implant. Some studies have suggested that a marginally oscillating bone loss between 1.5 and 2.0 mm provides the vertical space for proper restoration of the biological amplitude. Some authors. published a study that demonstrated that, in crestal systems with switching platforms, a vertical thickness of soft tissue greater than 2 mm is effective in preventing periimplant crestal bone loss. However, the severity of the sample examined precludes the possibility of making definitive conclusions.
Recently other authors have shown significant marginal bone loss around implants with lower prosthetic implants than those with higher prosthetic prostheses, without however measuring the thickness of soft tissues and evaluating their influence. In particular, the extent of bone loss was extremely limited when the height of the stump was equal to or greater than 2 mm. From a theoretical point of view, a prosthetic abutment of at least 2 mm high, calculated from the apical margin of the crown to the platform of the implant, should provide adequate space for restoring the biological amplitude.
It can therefore be hypothesized that these two factors (the vertical thickness of soft tissues and the height of the prosthetic stump) are the expression of the same principle: the restoration of the biological amplitude around the implant's neck. From a clinical point of view it will be useful to determine which of the two factors is most important in preventing and limiting periimplant bone loss.
- Conditions
- Bone Atrophy, Alveolar
- Being tested
- all on four implant rehabilitation
- Keywords
- all on four; piezoelectric; implant; trans-sinusal
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all on four implant rehabilitationProcedure or surgery
implant insertion after piezoelectric site preparation for trans-sinusal implants
| Study group | Role | What they receive |
|---|---|---|
| maxillary total edentulism | Experimental | all on four implant rehabilitation with trans-sinusal implants Receives: Procedure: all on four implant rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
percentage of implants surviving in oral cavity
Measured: two years after surgery
Secondary outcomes (1)
radiographic distance between crestal bone and implant platform
radiographically assessed
Measured: two years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start31 Oct 2017
- Primary completion31 Oct 2019
- Study completion15 Feb 2020
Why it stopped: no enough patients have been enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone Atrophy, AlveolarStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Piezosurgery Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy
- Investigators
- Claudio Stacchi, Dr, Study director, International Piezosurgery Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357692
- Sponsor's protocol ID
- Nobelsinus
- Acronym
- Nobelsinus
- Status last verified
- Sep 2020
- First submitted
- 23 Nov 2017
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malo P, Rangert B, Nobre M. "All-on-Four" immediate-function concept with Branemark System implants for completely edentulous mandibles: a retrospective clinical study. Clin Implant Dent Relat Res. 2003;5 Suppl 1:2-9. doi: 10.1111/j.1708-8208.2003.tb00010.x.
PubMed 12691645Agliardi EL, Tete S, Romeo D, Malchiodi L, Gherlone E. Immediate function of partial fixed rehabilitation with axial and tilted implants having intrasinus insertion. J Craniofac Surg. 2014 May;25(3):851-5. doi: 10.1097/SCS.0000000000000959.
PubMed 24820712
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Preparation of the Implant Site in the All-on-Four Technique With Trans-sinus Implants
- ClinicalTrials.gov ID
- NCT03357692
- Acronym / sponsor ID
- Nobelsinus / Nobelsinus
- Conditions
- Bone Atrophy, Alveolar
- Keywords
- all on four; piezoelectric; implant; trans-sinusal
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no enough patients have been enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- International Piezosurgery AcademyUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 30 Nov 2017 (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 objective of this observational study is the radiographic evaluation of marginal bone remodeling after surgical implant insertion in an immediate loading all-on-four technique with trans-sinusal titanium implants, correlating the gingival thickness and the height of the implant prosthetic stump with the proportion of the abovementioned marginal bone remodeling.
Detailed description
The extent of marginal bone remodeling around the neck of dental implants has been used for many years as a criterion for defining its long-term success.
In fact, the etiology of this Marginal Bone Loss has not yet been well understood, although many theories have been proposed to explain it.
The influence of the thickness of the mucous membrane on marginal bone loss was discussed elsewhere which suggests a protective action for the underlying soft tissue that recreates a kind of "biological amplitude" around the implant. Some studies have suggested that a marginally oscillating bone loss between 1.5 and 2.0 mm provides the vertical space for proper restoration of the biological amplitude. Some authors. published a study that demonstrated that, in crestal systems with switching platforms, a vertical thickness of soft tissue greater than 2 mm is effective in preventing periimplant crestal bone loss. However, the severity of the sample examined precludes the possibility of making definitive conclusions.
Recently other authors have shown significant marginal bone loss around implants with lower prosthetic implants than those with higher prosthetic prostheses, without however measuring the thickness of soft tissues and evaluating their influence. In particular, the extent of bone loss was extremely limited when the height of the stump was equal to or greater than 2 mm. From a theoretical point of view, a prosthetic abutment of at least 2 mm high, calculated from the apical margin of the crown to the platform of the implant, should provide adequate space for restoring the biological amplitude.
It can therefore be hypothesized that these two factors (the vertical thickness of soft tissues and the height of the prosthetic stump) are the expression of the same principle: the restoration of the biological amplitude around the implant's neck. From a clinical point of view it will be useful to determine which of the two factors is most important in preventing and limiting periimplant bone loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| maxillary total edentulism | Experimental | Procedure: all on four implant rehabilitationall on four implant rehabilitation with trans-sinusal implants |
Who may qualify
- Ages
- 19 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- indications for implant insertion into the maxillary upper jaw, based on a careful diagnosis and treatment plan;
- presence of a residual bone crest with a minimum surgical height of 4 mm at the maxillary sinus (bilaterally), and a thickness of at least 6 mm at the two distally programmed implant sites;
- presence of a residual bone crest with a minimum surgical height of 10 mm at the anterior maxilla, and a thickness of at least 6 mm at the mesially programmed implant sites;
- the bone crest should be healed (at least 6 months after the loss / extraction of the corresponding dental element);
- no regenerated bone;
Key exclusion criteria (3 listed)
- not treated diabetes
- cardiovascular disease
- incapability of maintaining a good oral hygiene
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 |
|---|---|---|
| all on four implant rehabilitationimplant insertion after piezoelectric site preparation for trans-sinusal implants | Procedure or surgery | maxillary total edentulism |
Primary outcome
survival rate
Time frame: two years after surgery
percentage of implants surviving in oral cavity
1 secondary outcome
radiographic distance between crestal bone and implant platform
Time frame: two years after surgery
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 17 Sep 2020.
- Background: PubMed 12691645Malo P, Rangert B, Nobre M. "All-on-Four" immediate-function concept with Branemark System implants for completely edentulous mandibles: a retrospective clinical study. Clin Implant Dent Relat Res. 2003;5 Suppl 1:2-9. doi: 10.1111/j.1708-8208.2003.tb00010.x.
- Background: PubMed 24820712Agliardi EL, Tete S, Romeo D, Malchiodi L, Gherlone E. Immediate function of partial fixed rehabilitation with axial and tilted implants having intrasinus insertion. J Craniofac Surg. 2014 May;25(3):851-5. doi: 10.1097/SCS.0000000000000959.
- Individual participant dataSharing planned: No
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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.
Claudio Stacchi, Dr study director
International Piezosurgery Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing all on four implant rehabilitation in people with Bone Atrophy, Alveolar, run by International Piezosurgery Academy at 1 site 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 3 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 17 Sep 2020. 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 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?
survival rate (time frame: two years after surgery). 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 NCT03357692, which also lists 2 linked publications.
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 Sep 2020; AzTrials last refreshed its copy on 28 Oct 2026.