Peri-implant Bone Formation of Grafted Sites Around Hydrophilic and Non-hydrophilic Dental Implants
NCT Number: NCT06460103
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Partially Edentulous Maxilla|Partially Edentulous Mandible
Interventions: DEVICE: Placement of a "Straumann® Bone Level Tapered implant SLActive®" (hydrophilic surface)|DEVICE: Placement of a "Straumann® Bone Level Tapered implant SLA®" (hydrophobic surface)
Sponsor: University Hospital, Geneva
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07
Completion Date: 2027-12

Summary:
Although bone grafting at the same time as the placement of dental implants is a common procedure in implantology, there are currently no data on the influence of different types of implant surfaces on bone healing, which is crucial for implant stability.

The primary objective of this study is to assess if implant surface properties, i.e. hydrophilicity, affect the osseointegration of the implant in simultaneously augmented bone.

The secondary objective is to assess if implant surface properties, i.e. surface hydrophilicity, may affect the quantity of newly formed bone in the implant in simultaneously augmented bone.

Surface hydrophilicity modification is a well-adapted concept in dental implantology and is clinically well-established.

In this prospective study, all participants will receive a bone graft after extraction. After randomization, one group will receive a provisional SLA surface implant and another group will receive a provisional SLActive surface implant. The same standard surgical procedure will be performed for both groups when the definitive implant will be placed.

The study will run for a total of 3 year, and 35 patients per group will be included.

The Straumann SLA and SLActive implants, Maxgraft allograft and collprotect collagen membranes used in this study are all approved products on the Swiss market.

Primary Outcome Measures: Bone-to-Implant Contact (BIC), The cross-sectional implant perimeter percentage in direct contact with newly formed bone over the total cross-sectional implant perimeter. Only the perimeter in contact with augmented bone will be considered for measuring this parameter., 3 weeks after implant placement
Secondary Outcome Measures: Percentage of newly formed bone area, The histological cross-sectional area covered by newly formed bone over the total cross-sectional area within a defined region of interest within the augmented sites., 3 weeks after implant placement|Graft particle area, The histological cross-sectional area covered by remaining graft particles over the total cross-sectional area within a defined region of interest within the augmented sites., 3 weeks after implant placement|Assessment of the tissue inflammatory response, A region of interest within the histological cross-sections of augmented areas will be evaluated with regards to the inflammatory tissue response by quantifying the number of white blood cells to determine the inflammatory score using a standardized four-point scoring scale ranging from "-" for not present to "+++" for markedly present., 3 weeks after implant placement|Assessment of the healing response, Vascularization, osteoblasts, and osteoclasts will be scored using a standardized four-point scoring scale ranging from "-" for not present to "+++" for markedly present.This measure will be used to assess the implant surface/bone graft combination's overall healing reaction., 3 weeks after implant placement