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Dimensional Changes of Peri-implant Facial Bone

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ClinicalTrials.gov Identifier: NCT01821092
Recruitment Status : Completed
First Posted : March 29, 2013
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Procedure: implant insertion and abutment connection Device: osseointegrated implant Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2013
Primary Completion Date : October 2014
Study Completion Date : September 2015
Arms and Interventions

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 Name: 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 Name: T3 implant, Biomet 3i


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821092


Locations
Italy
PROED, Institute for Professional Education in Dentistry
Torino, Italy, 10129
Sponsors and Collaborators
Proed
Investigators
Study Director: Daniele Cardaropoli, DDS Proed
More Information

Responsible Party: Proed
ClinicalTrials.gov Identifier: NCT01821092     History of Changes
Other Study ID Numbers: 03.2013.Don Bosco.PROED
First Posted: March 29, 2013    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Proed:
osseointegrated Implant, bone level

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw, Edentulous, Partially
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases