Dimensional Changes of Peri-implant Facial Bone

September 1, 2016 updated by: Proed, Torino, Italy

Horizontal and Vertical Dimensional Changes of Peri-implant Facial Bone Following Placement of T3 Implants: a 1-year Cone Beam Computed Tomography Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The long term results and benefit of implant insertion in the aesthetic area have been well documented.

In the past few years, facial dimensional changes to the alveolar process following implant placement are object os study for both humans and animals investigations Recent studies suggest that platform switching decreases bone loss by 30% to 50%. It seems that the creation of a biologic width affects peri-implant bone loss to a significant extent and that platform switching is effective when the mucosal thickness allows the establishment of an horizontal biologic width.

A new implant with an hybrid surface (T3) has been recently launched by Biomet 3i.Aim of the present study will be to evaluate the degree of 3D marginal bone remodelling around T3 Prevail implants.

MATERIALS & METHODS:

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. Implants can be placed both with a single-stage or two-stage procedure. Implants inserted with a two-stage procedure will be re-opened after a submerged period of three months.

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.

It is supposed that the creation of the biological width starts with the healing abutment's connection.

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Torino, Italy, 10129
        • PROED, Institute for Professional Education in Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy adult patients requiring implant insertion -

Exclusion Criteria:

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: standard implant, switching platform
osseointegrated implant insertion and abutment connection Implants inserted in healed ridge, prosthetic connection with switching platform
Procedure: implant insertion and abutment connection
After implant insertion, immediate or in healed ridge, the titanium abutment with switching platform will be connected
Device: osseointegrated implant
Osseointegrated Implant Insertion
Other Names:
  • T3 implant, Biomet 3i
ACTIVE_COMPARATOR: immediate implant, switching platform
osseointegrated implant insertion and abutment connection Implants inserted in immediate post-extraction sites, prosthetic connection with switching platform
Procedure: implant insertion and abutment connection
After implant insertion, immediate or in healed ridge, the titanium abutment with switching platform will be connected
Device: osseointegrated implant
Osseointegrated Implant Insertion
Other Names:
  • T3 implant, Biomet 3i

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
horizontal buccal bone thickness
Time Frame: 12 months after abutment connection
On Cone Beam images, the horizontal dimensional changes of peri-implant facial bone will be measured
12 months after abutment connection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vertical bone level
Time Frame: 1 year after abutment connection
On Cone Beam images, the vertical dimensional changes of peri-implant facial bone will be measured
1 year after abutment connection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Proed, Torino, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

March 26, 2013

First Submitted That Met QC Criteria

March 28, 2013

First Posted (ESTIMATE)

March 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03.2013.Don Bosco.PROED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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