All-on-Four Implants With Ultrasonic (Nobelsinus)
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|ClinicalTrials.gov Identifier: NCT03357692|
Recruitment Status : Withdrawn (no enough patients have been enrolled)
First Posted : November 30, 2017
Last Update Posted : September 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bone Atrophy, Alveolar||Procedure: all on four implant rehabilitation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ultrasonic Preparation of the Implant Site in the All-on-Four Technique With Trans-sinus Implants|
|Actual Study Start Date :||October 31, 2017|
|Actual Primary Completion Date :||October 31, 2019|
|Actual Study Completion Date :||February 15, 2020|
Experimental: maxillary total edentulism
all on four implant rehabilitation with trans-sinusal implants
Procedure: all on four implant rehabilitation
implant insertion after piezoelectric site preparation for trans-sinusal implants
- survival rate [ Time Frame: two years after surgery ]percentage of implants surviving in oral cavity
- radiographic distance between crestal bone and implant platform [ Time Frame: two years after surgery ]radiographically assessed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357692
|Parma, Italy, 43100|
|Study Director:||Claudio Stacchi, Dr||International Piezosurgery Academy|