Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study
Condition: Jaw, Edentulous, Partially
MeSH terms: Jaw, Edentulous; Jaw, Edentulous, Partially
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): implant insertion and abutment connection
Intervention type(s): Procedure
Intervention description(s): After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osseointegrated Implant, Bone level