NCT00906165

The Role of Immediate Provisional Restorations on Bone Level Implants

The Role of Immediate Provisional Restorations on Bone Level Implants. A Randomised, Single Blind Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Institut Straumann AG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to evaluate the clinical and radiographic outcomes of Straumann® Bone Level Implant SLActive placed in healed alveolar ridge (at least 8 weeks post extraction) and immediately provisionalised versus the same type of implants placed in healed alveolar ridge but not provisionalised. In both cases the implants will be loaded at 16 weeks (final restorations). The outcomes will be evaluated over a 2-year period.

Detailed description

This is a prospective, randomised, controlled, single blind, and single center study. The total study duration for each patient should be 24 months. Straumann Bone Level Ø 4.1 mm SLActive implants will be placed for single tooth replacement, followed by either immediate provisional prosthetic loading or no provisionalised. The final prosthetic loading is made at 16 weeks after implant loading. The implant length will be selected according to the clinical indication of the site based on previous radiographic evaluation. In total 11 visits per patient are scheduled in this study. Bone level changes, implant success and survival rate, soft tissue changes, aesthetic outcome and adverse events (AEs) will be assessed. The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products. One center in the United Kingdom will participate.

Conditions

• Jaw, Edentulous, Partially

Interventions

Type	Name	Description
DEVICE	Straumann® Bone Level SLActive Implant (4.1mm diameter)	Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration)

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-11-01
• Completion: 2016-04-01
• First posted: 2009-05-21
• Last updated: 2019-03-15
• Results posted: 2019-03-15

Locations

1 site across 1 country: United Kingdom