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NOT YET RECRUITING
NCT06460103
NA

Peri-implant Bone Formation of Grafted Sites Around Hydrophilic and Non-hydrophilic Dental Implants

Sponsor: University Hospital, Geneva

View on ClinicalTrials.gov

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.

Official title: Effect of Implant Surface Hydrophilicity on Peri-Implant Bone Formation Around Simultaneously Grafted Transiently Placed Titanium Zirconium Dental Small Diameter Implants - A Randomized Controlled Human Histometric Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2024-07

Completion Date

2027-12

Last Updated

2024-06-14

Healthy Volunteers

No

Interventions

DEVICE

Placement of a "Straumann® Bone Level Tapered implant SLActive®" (hydrophilic surface)

Immediately after tooth extraction, patients will receive a "Straumann® Bone Level Tapered SLActive®" mini-implant at the ideal prosthetic position of the final implant, and bone augmentation using bone graft "maxgraft® " and dental membrane "collprotect®membrane". The mini-implant will be removed as a core trephine biopsy; the resulting osteotomies will be fine-prepared, and the final permanent implant will be placed after a healing period of 3 weeks post-augmentation.

DEVICE

Placement of a "Straumann® Bone Level Tapered implant SLA®" (hydrophobic surface)

Immediately after tooth extraction, patients will receive a "Straumann® Bone Level Tapered SLA®" mini-implant at the ideal prosthetic position of the final implant, and bone augmentation using bone graft "maxgraft® " and dental membrane "collprotect®membrane". The mini-implant will be removed as a core trephine biopsy; the resulting osteotomies will be fine-prepared, and the final permanent implant will be placed after a healing period of 3 weeks post-augmentation.