Clinical Assessment of UV Photofunctionalization on Stability and Osseointegration of Early Loaded Implants

Background and Scientific Rationale Standard titanium dental implants are prone to "biological aging" during storage, a process characterized by the progressive accumulation of atmospheric hydrocarbons on the implant surface. This contamination negatively alters the electrostatic charge of the surface and increases its hydrophobicity. Consequently, the hydrophobic surface impairs critical early healing steps, specifically the adsorption of proteins and the attachment of osteoblasts (bone-forming cells), which can compromise early implant stability. To overcome this biological challenge, the study utilizes Ultraviolet Photofunctionalization (UV phF). This chairside conditioning method uses UVC light to decompose organic contaminants, remove hydrocarbons, and expose the underlying titanium dioxide layer. The treatment converts the implant surface to a "super-hydrophilic" state, which is hypothesized to significantly improve the affinity for osteogenic cells, accelerate bone deposition, and enhance early bone-implant contact (BIC). This accelerated osseointegration is essential for successfully executing a demanding 4 to 6-week early loading protocol in the posterior mandible. Study Design and Participant Selection This is a prospective, single-arm clinical trial targeting adult patients (18 years and older) who require single or multiple dental implants in a healed edentulous ridge of the mandibular posterior area. The bone quality at the target site must be classified as D2 or D3 based on pre-operative CBCT imaging, with sufficient bone volume to avoid major grafting procedures. The study calculates a target recruitment of 22 patients to allow for a 20% attrition rate, ensuring that a minimum of 18 evaluable implants are available to achieve an 80% statistical power. Patients will be excluded if they have uncontrolled systemic diseases, D1 or D4 bone quality, active infection, periodontal disease, are pregnant or lactating, or smoke more than 10 cigarettes per day. Interventions and Surgical ProceduresImplant Preparation: Point UV® Implants (Titanium Grade 4) will undergo UV phF surface treatment according to the manufacturer's specified 12 to 24-hour cycle prior to placement. Surgical Phase: The procedure will be performed under local anesthesia, beginning with the elevation of a full-thickness envelope flap. After site preparation, the UV-treated implant will be inserted. Initial Measurements: The insertion torque will be immediately recorded using a calibrated torque wrench, and the primary implant stability (IST) will be measured on Day 1. Post-Operative Care: The surgical flap will be sutured, and patients will be prescribed Amoxicillin/Clavulanic acid (875 mg/125 mg) for 5 days, Ibuprofen (400 mg) for 3 days, and a Chlorhexidine (0.12-0.2%) mouthwash for 1 week. Sutures will be removed two weeks post-surgery, and a soft diet is recommended for the first 7 days. Measurement Device and Loading Protocol Implant stability will be assessed using the AnyCheck® device, which utilizes a non-invasive magnetic percussion method. Unlike traditional resonance frequency analysis that requires removing the healing abutment, AnyCheck taps directly against the existing healing abutment, preserving the soft-tissue biological seal during the healing phase. Measurements will be taken on Day 1, Week 2, Week 4, and Week 6. The early loading protocol (placement of the final prosthetic restoration) will only proceed at 4 to 6 weeks if specific criteria are met: The initial IST recorded on Day 1 must be ≥ 70. The follow-up IST at Week 4 to 6 must be ≥ 65. If these stability thresholds are not met, loading will be postponed and reassessed at Week 8. Follow-Up and Secondary Outcomes All patients will be monitored for at least 6 months following the delivery of the final prosthesis. Secondary outcomes include evaluating marginal bone level changes using a parallel-technique periapical X-ray at 1, 3, and 6 months. Additionally, the peri-implant soft-tissue response will be assessed using a periodontal probe 6 months after the final prosthesis is placed. Any adverse effects, such as pain, swelling, infection, or mobility before loading, will be recorded, and such implants may be excluded from the final analysis.