All-on-Four Implants With Ultrasonic (Nobelsinus)
Primary Purpose
Bone Atrophy, Alveolar
Status
Withdrawn
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
all on four implant rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Bone Atrophy, Alveolar focused on measuring all on four; piezoelectric; implant; trans-sinusal
Eligibility Criteria
Inclusion Criteria:
- 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%;
- 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.
Exclusion Criteria:
- not treated diabetes
- cardiovascular disease
- incapability of maintaining a good oral hygiene
Sites / Locations
- Piezosurgery Academy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
maxillary total edentulism
Arm Description
all on four implant rehabilitation with trans-sinusal implants
Outcomes
Primary Outcome Measures
survival rate
percentage of implants surviving in oral cavity
Secondary Outcome Measures
radiographic distance between crestal bone and implant platform
radiographically assessed
Full Information
NCT ID
NCT03357692
First Posted
November 23, 2017
Last Updated
September 15, 2020
Sponsor
International Piezosurgery Academy
1. Study Identification
Unique Protocol Identification Number
NCT03357692
Brief Title
All-on-Four Implants With Ultrasonic
Acronym
Nobelsinus
Official Title
Ultrasonic Preparation of the Implant Site in the All-on-Four Technique With Trans-sinus Implants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
no enough patients have been enrolled
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
February 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Piezosurgery Academy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Atrophy, Alveolar
Keywords
all on four; piezoelectric; implant; trans-sinusal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
maxillary total edentulism
Arm Type
Experimental
Arm Description
all on four implant rehabilitation with trans-sinusal implants
Intervention Type
Procedure
Intervention Name(s)
all on four implant rehabilitation
Intervention Description
implant insertion after piezoelectric site preparation for trans-sinusal implants
Primary Outcome Measure Information:
Title
survival rate
Description
percentage of implants surviving in oral cavity
Time Frame
two years after surgery
Secondary Outcome Measure Information:
Title
radiographic distance between crestal bone and implant platform
Description
radiographically assessed
Time Frame
two years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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%;
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.
Exclusion Criteria:
not treated diabetes
cardiovascular disease
incapability of maintaining a good oral hygiene
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Stacchi, Dr
Organizational Affiliation
International Piezosurgery Academy
Official's Role
Study Director
Facility Information:
Facility Name
Piezosurgery Academy
City
Parma
ZIP/Postal Code
43100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12691645
Citation
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.
Results Reference
background
PubMed Identifier
24820712
Citation
Agliardi 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.
Results Reference
background
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All-on-Four Implants With Ultrasonic
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