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Dimensional Changes of Peri-implant Facial Bone

Primary Purpose

Jaw, Edentulous, Partially

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
implant insertion and abutment connection
osseointegrated implant
Sponsored by
Proed, Torino, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring osseointegrated Implant, bone level

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • PROED, Institute for Professional Education in Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

standard implant, switching platform

immediate implant, switching platform

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2013
Last Updated
September 1, 2016
Sponsor
Proed, Torino, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01821092
Brief Title
Dimensional Changes of Peri-implant Facial Bone
Official Title
Horizontal and Vertical Dimensional Changes of Peri-implant Facial Bone Following Placement of T3 Implants: a 1-year Cone Beam Computed Tomography Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Proed, Torino, Italy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
Keywords
osseointegrated Implant, bone level

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard implant, switching platform
Arm Type
Active Comparator
Arm Description
osseointegrated implant insertion and abutment connection Implants inserted in healed ridge, prosthetic connection with switching platform
Arm Title
immediate implant, switching platform
Arm Type
Active Comparator
Arm Description
osseointegrated implant insertion and abutment connection Implants inserted in immediate post-extraction sites, prosthetic connection with switching platform
Intervention Type
Procedure
Intervention Name(s)
implant insertion and abutment connection
Intervention Description
After implant insertion, immediate or in healed ridge, the titanium abutment with switching platform will be connected
Intervention Type
Device
Intervention Name(s)
osseointegrated implant
Other Intervention Name(s)
T3 implant, Biomet 3i
Intervention Description
Osseointegrated Implant Insertion
Primary Outcome Measure Information:
Title
horizontal buccal bone thickness
Description
On Cone Beam images, the horizontal dimensional changes of peri-implant facial bone will be measured
Time Frame
12 months after abutment connection
Secondary Outcome Measure Information:
Title
vertical bone level
Description
On Cone Beam images, the vertical dimensional changes of peri-implant facial bone will be measured
Time Frame
1 year after abutment connection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniele Cardaropoli, DDS
Organizational Affiliation
Proed, Torino, Italy
Official's Role
Study Director
Facility Information:
Facility Name
PROED, Institute for Professional Education in Dentistry
City
Torino
ZIP/Postal Code
10129
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Dimensional Changes of Peri-implant Facial Bone

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