Immediate vs Delayed Placement of Straumann BLX Implants in Molar Extraction Sockets
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Osstell Value Assessment
Study Overview
Brief Summary
The aim of this study is to clinically and radiographically compare the success and survival of implants immediately placed in molar fresh extraction socket to delayed implant placement at least 12 weeks post molar extraction. The secondary aim is to evaluate the peri-implant tissue response around implants with immediate vs. delayed placement.
Detailed Description
Study Population To be included in the study, the subjects must be 22 years of age or older and in good general health. They must have at least one nonrestorable more indicated for extraction and immediate or delayed implant placement. Subjects who are unable to undergo oral surgery procedures, smokers, and women who are (or become) pregnant (or are breastfeeding) will be excluded from this study. Additionally, subjects with bone infections or compromised health that may affect the ability of the patients' tissues to heal (e.g., uncontrolled diabetes, bisphosphonate use, current glucocorticoid use) will not be included in this clinical study.
15 implants in each group are necessary to provide 90% power with a type I error of 0.05. Each subject will be randomly assigned into one of two treatment groups:
Test Group (n=15):
The test group will receive immediate molar implant placement in fresh extraction socket with nonocclusal loading immediate provisionalization (Straumann BLX 6.5mm).
Control Group (n=15):
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 78 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •22 years of age or older
- •good general health.
- •at least one nonrestorable more indicated for extraction and immediate or delayed implant placement
Exclusion Criteria
- •undergo oral surgery procedures
- •women who are (or become) pregnant (or are breastfeeding)
- •subjects with bone infections or compromised health that may affect the ability of the patients' tissues to heal (e.g., uncontrolled diabetes, bisphosphonate use, current glucocorticoid use)
Arms & Interventions
test group
The test group will receive immediate molar implant placement in fresh extraction socket with nonocclusal loading immediate provisionalization (Straumann BLX 6.5mm).
Intervention: Immediate placement non-occlusal loading molar implant (Straumann BLX 6.5mm) (Device)
Control group
The control group will receive delayed molar implant placement at least 12 weeks post molar extraction with nonocclusal loading immediate provisionalization (Straumann BLX 5.0mm).
Intervention: Delayed placement non-occlusal loading molar implant (Straumann BLX 5.0mm) (Device)
Outcomes
Primary Outcomes
Osstell Value Assessment
Time Frame: 12 months
Osstell® RFA (Resonance Frequency Analysis) values will be recorded immediately after implant placement, 3 months, and 12 months follow up visits to report implant stability during the healing time. RFA values for each implant will be statistically analyzed and compared between and within groups utilizing SPSS software.
3D Printed Models Assessment
Time Frame: 12 months
3D printed models will be generated from intraoral scan prior to baseline extraction visit and 3, 12 months follow up. Volumetric changes will be measured and analyzed digitally with compare software.
Photographic Documentation
Time Frame: 12 months
Photographic documentation will be made using a digital camera for each visit to clinically evaluate the peri-implant tissue healing response around implants with immediate vs. early placements.
Clinical Examination: Implant Success and Failure Criteria
Time Frame: 12 months
Implant success is defined by clinical and radiographic parameters. The success criteria for the implants will be (1) no radiolucency around the implant, (2) no mobility, and (3) no suppuration, pain, or ongoing pathologic process. Implants that do not meet the above criteria fall under the implant failure category. Success rate percentage will be based on clinical and radiographic assessment per implant site.
Radiographic Examination
Time Frame: 12 months
Regional Cone Beam CT scan imaging for implant sites will be made for research purposes at baseline after implant placement, and 12 months follow up visits. These images are the only way to provide 3 dimensional view of bone around implants (Mesial-Distal, Buccal-Lingual). Marginal bone level changes will be recorded on the mid-mesial, mid-distal, mid-labial, and mid-lingual sites for each implant from the reference line (RL) of the implant platform immediately after implant placement and 12 months follow up visits. All measurements will be made utilizing a coDiagnostiX software used at University of Kentucky College of Dentistry. Marginal bone changes around implants for each site (i.e., Mesial, Distal, Buccal, and Lingual) will be digitally analyzed using the software and statistically analyzed and compared between groups utilizing SPSS software.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ahmad Kutkut
Associate Professor
University of Kentucky