Trial record 11 of 92 for:    Open Studies | "Jaw"

Dimensional Changes of Peri-implant Facial Bone

This study is currently recruiting participants.
Verified March 2013 by Proed
Sponsor:
Information provided by (Responsible Party):
Proed
ClinicalTrials.gov Identifier:
NCT01821092
First received: March 26, 2013
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Jaw, Edentulous, Partially
Procedure: implant insertion and abutment connection
Device: osseointegrated implant
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Proed:

Primary Outcome Measures:
  • horizontal buccal bone thickness [ Time Frame: 12 months after abutment connection ] [ Designated as safety issue: No ]
    On Cone Beam images, the horizontal dimensional changes of peri-implant facial bone will be measured


Secondary Outcome Measures:
  • vertical bone level [ Time Frame: 1 year after abutment connection ] [ Designated as safety issue: No ]
    On Cone Beam images, the vertical dimensional changes of peri-implant facial bone will be measured


Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Other Name: T3 implant, Biomet 3i

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01821092

Contacts
Contact: Daniele Cardaropoli, DDS +39.338.6688933 dacardar@tin.it

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

No publications provided

Responsible Party: Proed
ClinicalTrials.gov Identifier: NCT01821092     History of Changes
Other Study ID Numbers: 03.2013.Don Bosco.PROED
Study First Received: March 26, 2013
Last Updated: March 28, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Proed:
osseointegrated Implant, bone level

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

ClinicalTrials.gov processed this record on April 15, 2014