Jaw, Edentulous, Partially Clinical Trial
Official title:
Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study
Aim of the present study will be to evaluate if the platform switching and the flat abutment
can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft
tissues will also be provided.
80 consecutively inserted dental implants will be included in this study. Maxillary and
mandibular implants will be considered, both in frontal and posterior area. After 6 to 12
weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented.
After 2 more months, the definitive porcelain crown will be delivered. The final outcomes
will be collected after 1 year from implant insertion.
Data will refer to the following timing:
T0= implant installation T1= temporary crown cementation T2= definitive crown cementation
T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants
each, with different implant/abutment design.
Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3
Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants +
GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments On x-rays,
the mesial and distal Marginal Bone Level will be measured and compared among and between
the groups at the 4 different timing.
Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured
at T0, T1, T2 and T3. Data will be statistically analyzed.
BACKGROUND:
Platform switching is intended to preserve marginal bone around implants. Studies have shown
that implants using an integrated platform switching demonstrate crestal bone loss as low as
0.37mm, and 30 to 50% reduction in crestal bone loss when compared to non-platform switching
implants. Recently, a new design titanium abutment (Tissuemax IL) has been proposed to
modulate the soft tissue integration around implant supported crowns. A new implant with a
hybrid surface (T3) has been recently launched by Biomet 3i, providing both integrated
platform switching (Prevail) or non platform switching (Standard Collar).
Aim of the present study will be to evaluate if the platform switching and the Tissuemax
abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the
soft tissues will also be provided.
MATERIALS & METHODS:
80 consecutively inserted dental implants will be included in this study. Maxillary and
mandibular implants will be considered, both in frontal and posterior area. Implants should
be inserted in preexisting adequate bone volume, without the need for any bone augmentation
technique. Implants will be inserted with a transmucosal healing (single-stage surgical
procedure) with immediate connection of the healing abutment. After 6 to 12 weeks, the
definitive prosthetic abutment will be screwed and the temporary crown cemented. After 2
more months, the definitive porcelain crown will be delivered. The final outcomes will be
collected after 1 year from implant insertion.
Data will refer to the following timing:
T0= implant installation T1= temporary crown cementation T2= definitive crown cementation
T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants
each, with different implant/abutment design.
Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3
Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants +
GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments The
division into the 4 group will be randomized. Standardized intraoral radiograms will be done
at T0, T1, T2 and T3. On x-rays, the mesial and distal Marginal Bone Level will be measured
and compared among and between the groups at the 4 different timing.
Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured
at T0, T1, T2 and T3. Data will be statistically analyzed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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