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Dimensional Changes of Peri-implant Facial Bone

P

Proed, Torino, Italy

Status and phase

Completed
Phase 4

Conditions

Jaw, Edentulous, Partially

Treatments

Procedure: implant insertion and abutment connection
Device: osseointegrated implant

Study type

Interventional

Funder types

Other

Identifiers

NCT01821092
03.2013.Don Bosco.PROED

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

standard implant, switching platform
Active Comparator group
Description:
osseointegrated implant insertion and abutment connection Implants inserted in healed ridge, prosthetic connection with switching platform
Treatment:
Procedure: implant insertion and abutment connection
Device: osseointegrated implant
immediate implant, switching platform
Active Comparator group
Description:
osseointegrated implant insertion and abutment connection Implants inserted in immediate post-extraction sites, prosthetic connection with switching platform
Treatment:
Procedure: implant insertion and abutment connection
Device: osseointegrated implant

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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