Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-01-04 @ 8:38 AM
Study NCT ID:
NCT03357692
Status:
WITHDRAWN
Last Update Posted:
2020-09-17
First Post:
2017-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
All-on-Four Implants With Ultrasonic
Sponsor:
International Piezosurgery Academy
Organization:
Study Overview
Official Title:
Ultrasonic Preparation of the Implant Site in the All-on-Four Technique With Trans-sinus Implants
Status:
WITHDRAWN
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no enough patients have been enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Nobelsinus
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: