NCT01821092

Brief Summary

40 consecutive adult patients, requiring the insertion of dental implants in the aesthetic area (from second premolar to second premolar) will be enrolled in the study. At the time of surgery, a full thickness flap will be elevated, the implant bed will be prepared according to the manufacturer's instruction and the implants will be then seated into the bone. T0 corresponds to the time of implant insertion, T1 to the time of healing abutment's connection (T0=T1 for single stage implants), and T2 corresponds to 1-year follow-up from healing abutment's connection. Cone Beam Computed Tomography (CBCT) scans will be taken immediately after abutment connection (T1) and 1-year after (T2). The midsagittal cut of each implant will be identified, and measurements will be made at predetermined levels. Horizontal facial bone thickness (HFBT) and Vertical facial bone level (VFBL) will be measured. HFBT will be measured at 0, 3, 6 and 9 mm apical to the implant platform. VFBL wil be the perpendicular distance from the implant platform to the most coronal point of the facial bone. Changes between T1 and T2 will be calculated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 2, 2016

Status Verified

September 1, 2016

Enrollment Period

1.6 years

First QC Date

March 26, 2013

Last Update Submit

September 1, 2016

Conditions

Jaw, Edentulous, Partially

Keywords

osseointegrated Implant, bone level

Outcome Measures

Primary Outcomes (1)

  • horizontal buccal bone thickness

    On Cone Beam images, the horizontal dimensional changes of peri-implant facial bone will be measured

    12 months after abutment connection

Secondary Outcomes (1)

  • vertical bone level

    1 year after abutment connection

Study Arms (2)

standard implant, switching platform

ACTIVE COMPARATOR

osseointegrated implant insertion and abutment connection Implants inserted in healed ridge, prosthetic connection with switching platform

Procedure: implant insertion and abutment connectionDevice: osseointegrated implant

immediate implant, switching platform

ACTIVE COMPARATOR

osseointegrated implant insertion and abutment connection Implants inserted in immediate post-extraction sites, prosthetic connection with switching platform

Procedure: implant insertion and abutment connectionDevice: osseointegrated implant

Interventions

implant insertion and abutment connectionPROCEDURE

After implant insertion, immediate or in healed ridge, the titanium abutment with switching platform will be connected

immediate implant, switching platformstandard implant, switching platform
osseointegrated implantDEVICE

Osseointegrated Implant Insertion

Also known as: T3 implant, Biomet 3i
immediate implant, switching platformstandard implant, switching platform

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult patients requiring implant insertion -

You may not qualify if:

  • Pregnancy history of malignancy history of radiotherapy or chemotherapy in the last 5 years long term steroidal or antibiotic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PROED, Institute for Professional Education in Dentistry

Torino, 10129, Italy

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Interventions

Bone-Anchored Prosthesis

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Daniele Cardaropoli, DDS

    Proed, Torino, Italy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2013

First Posted

March 29, 2013

Study Start

March 1, 2013

Primary Completion

October 1, 2014

Study Completion

September 1, 2015

Last Updated

September 2, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)