Dimensional Changes of Peri-implant Facial Bone
Condition: Jaw, Edentulous, Partially
MeSH terms: Jaw, Edentulous; Jaw, Edentulous, Partially
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): implant insertion and abutment connection; osseointegrated implant
Intervention type(s): Procedure; Device
Intervention description(s): After implant insertion, immediate or in healed ridge, the titanium abutment with switching platform will be connected; Osseointegrated Implant Insertion
Other intervention name(s): T3 implant, Biomet 3i
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: osseointegrated Implant, bone level