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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
28
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)
Eastman Dental Institute, University College London
London, United Kingdom
Radiographic Bone Level Change at the Mesial and Distal of the Implants Between Baseline and One Year Post Treatment
The primary parameter derives from the subtraction of mesial and distal bone level linear x-ray measurements at baseline and one year after implant placement. The distance between the alveolar bone at the level of the first radiographic bone contact with the implant surface and the shoulder of the implant will be measured to the closest 0.1mm at the mesial and distal surfaces of all implants, on digitized standardized peri-apical x-rays using an image analysis computer program.
Time frame: between baseline and one year post treatment
Number of Participants With Survival Rate of the Implants at 12 and 24 Months
The survival rate of the implants is presented as a cumulative survival rate at 1 year and 2 years post-implant placement.
Time frame: 1 year and 2 years after implant placement
No. of Participants With Complications of the Implant and Implant Overstructure at 24 Months
No of participants with prosthetic related complications and with implant failures are described after 24 months
Time frame: 2 years after implant placement
Probing Pocket Depth
The Probing Pocket Depth around the implants will be measured using a UNC-15 probe with light probing force (0.2N) at the post-implant time-points specified. Differences between the Outcome Measure time points will be displayed. Baseline is 16 weeks (loading of implants)
Time frame: Recorded at 16 weeks, 6, 12, and 24 months after implant placement
Gingival Recessions (REC)
The gingival recessions around the implants are recorded at the above-specified timepoints after implant placement, using a UNC-15 probe. Differences between the Outcome Measure time points will be displayed. Baseline is 16 weeks (loading of implants)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Recorded at 16 weeks, 6, 12 and 24 months after implant placement
Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index
Soft tissue changes: mesial and distal gingival papilla dimensions assessed by Papilla Fill Index (PFI, Jemt 1997) and the Pink Aesthetic Score (PES, Furhauser 2005) will be recorded at the post-implant placement timepoints specified above.
Time frame: Recorded at 12 and 24 months after implant placement
Adverse Events
Adverse Events (AE) and Serious Adverse Events (SAE) will be assessed and followed up throughout the study duration
Time frame: From randomization to 2 years after implant placement
Soft Tissue Changes, Pink Aesthetic Score
Soft tissue changes: the Pink Aesthetic Score (PES, Furhauser 2005) will be recorded at the post-implant placement timepoints specified above. The PES index includes assessment of seven variables and each variable is measured with a 2, 1, or 0 score with 2 being the best and 0 being the poorest score. Based on its definition the PES is a cumulative score with 14 being the best and 0 the worst.
Time frame: Recorded at 12 and 24 months after implant placement