NCT03357692

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

November 23, 2017

Last Update Submit

September 15, 2020

Conditions

Bone Atrophy, Alveolar

Keywords

all on four; piezoelectric; implant; trans-sinusal

Outcome Measures

Primary Outcomes (1)

  • survival rate

    percentage of implants surviving in oral cavity

    two years after surgery

Secondary Outcomes (1)

  • radiographic distance between crestal bone and implant platform

    two years after surgery

Study Arms (1)

maxillary total edentulism

EXPERIMENTAL

all on four implant rehabilitation with trans-sinusal implants

Procedure: all on four implant rehabilitation

Interventions

all on four implant rehabilitationPROCEDURE

implant insertion after piezoelectric site preparation for trans-sinusal implants

maxillary total edentulism

Eligibility Criteria

Age19 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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);
  • \) Patients should be able to examine and understand the protocol of study; 9) subscribing to informed consent.

You may not qualify if:

  • not treated diabetes
  • cardiovascular disease
  • incapability of maintaining a good oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piezosurgery Academy

Parma, 43100, Italy

Location

Related Publications (2)

  • 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.

    PMID: 12691645BACKGROUND

  • 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.

    PMID: 24820712BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Claudio Stacchi, Dr

    International Piezosurgery Academy

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of the International Piezosurgery Academy

Study Record Dates

First Submitted

November 23, 2017

First Posted

November 30, 2017

Study Start

October 31, 2017

Primary Completion

October 31, 2019

Study Completion

February 15, 2020

Last Updated

September 17, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)