CClinicalTrials.gg
WithdrawnNCT03357692NobelsinusUpdated Sep 17, 2020

All-on-Four Implants With Ultrasonic

An interventional study of all on four implant rehabilitation in Bone Atrophy, Alveolar, sponsored by International Piezosurgery Academy. Withdrawn at 1 site in Italy. Open to participants aged 19 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-17.

Sponsored by International Piezosurgery Academy · Not applicable, Interventional, and Treatment

Why this study was withdrawn
no enough patients have been enrolled
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
19 Months and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Bone Atrophy, Alveolar

Browse trials for

Keywords

  • all on four; piezoelectric; implant; trans-sinusal
03

Who can participate

Ages eligible
19 Months and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. indications for implant insertion into the maxillary upper jaw, based on a careful diagnosis and treatment plan;
  2. 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;
  3. 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;
  4. the bone crest should be healed (at least 6 months after the loss / extraction of the corresponding dental element);
  5. no regenerated bone;
  6. Plaque index below 25% and bleeding index less than 20%;
  7. the buccal length of the adherent gingiva ≥ 4 mm;
  8. age of the patient> 18 years;
  9. systemic condition of the compensated patient (American Society of Anesthesiologist score \< 2);
  1. Patients should be able to examine and understand the protocol of study; 9) subscribing to informed consent.

Exclusion criteria

Exclusion Criteria:

  1. not treated diabetes
  2. cardiovascular disease
  3. incapability of maintaining a good oral hygiene
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    maxillary total edentulism

    all on four implant rehabilitation with trans-sinusal implants

    Procedure: all on four implant rehabilitation

Interventions

  • Procedureall on four implant rehabilitation

    implant insertion after piezoelectric site preparation for trans-sinusal implants

05

What researchers measure

Primary outcomes

  1. survival rate

    percentage of implants surviving in oral cavity

    Time frame: two years after surgery

Secondary outcomes

  1. radiographic distance between crestal bone and implant platform

    radiographically assessed

    Time frame: two years after surgery

06

Study locations

1 site
  • Piezosurgery Academy
    Parma, 43100, Italy
07

References and documents

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 12691645 ↗
  • 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. PubMed 24820712 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03357692
Lead sponsor
International Piezosurgery Academy
Responsible party
Mr. Claudio Stacchi, DDS, MSc (President of the International Piezosurgery Academy, International Piezosurgery Academy) — Principal investigator
First posted
Nov 30, 2017
Start date
Oct 31, 2017
Primary completion
Oct 31, 2019
Completion
Feb 15, 2020
Last update
Sep 17, 2020

Study contacts

Claudio Stacchi, Dr
study director · International Piezosurgery Academy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion