An interventional study of UV-photofunctionalized titanium dental implants in Evaluating the Clinical Efficacy of Applying Ultraviolet Photofunctionalization (UV phF) to Standard Titanium Implants Immediately Before Surgery, Monitoring Early Implant Stability and Osseointegration During the Critical Initial Healing Phase and Determining the Feasibility and Success Rate of an Accelerated "Early Loading" Protocol, sponsored by Future University in Egypt. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if UV light treatment (photo functionalization) works to help dental implants heal faster and become stable enough for early use in adults missing teeth in the lower back jaw. It will also learn about the survival rate and safety of these implants. The main questions it aims to answer are: Do the UV-treated implants achieve the required stability score (IST ≥ 65) at 4 to 6 weeks to allow for early placement of the artificial tooth? What are the implant survival rates, and how do the gums and surrounding bone respond 6 months after the artificial tooth is placed? Researchers will test the stability of these UV-treated implants against a standard clinical threshold to see if they safely support an early treatment timeline. Participants will :Have a UV-treated titanium dental implant surgically placed in their lower jaw. Visit the clinic for check ups and non-invasive stability tests at 2 weeks, 4 weeks, and 6 weeks after surgery. Receive their final artificial tooth between 4 to 6 weeks, provided the implant is completely stable. Return for follow-up X-rays and tissue checks at 1, 3, and 6 months after receiving the artificial tooth.
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.
Future University in Egypt is the lead sponsor of 103 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
The study is defined as a "single-arm, clinical study". Because there is only one group in the trial, all participants are enrolled into this single arm and receive the intervention being tested (the UV-photofunctionalized dental implants). Therefore, this arm serves as the experimental group. There are no comparator, placebo, or sham arms in this study.
Device: UV-photofunctionalized titanium dental implants
Unlike standard titanium implants that are placed directly from the packaging, the implants in this study (Point UV® Implant System, Titanium Grade 4) undergo Ultraviolet Photofunctionalization (UV phF) immediately prior to surgical insertion to activate the implant surface. The surgical placement is strictly limited to healed edentulous ridges located specifically in the mandibular posterior area (lower jaw).The intervention is exclusively performed on patients categorized as having D2 or D3 bone quality, verified by pre-operative CBCT scans. The intervention employs an early loading prosthetic protocol, distinguishing it from conventional/delayed loading approaches.
Also known as: Point UV Implant, UV-phF titanium implants
Primary implant stability
mplant Stability Test (IST): Stability is quantified via IST values using the AnyCheck® device, which employs a non-invasive magnetic percussion method. Insertion Torque: Mechanical stability at placement is measured in Newton centimeters (N·cm/Nm) using a calibrated torque wrench.
Time frame: IST values are recorded immediately after the surgical placement (Day 1 / Day 0), and during follow-up visits at Week 2, Week 4, and Week 6.
Assessing the overall survival and success of the implants at 6 months after functional loading.
This metric tracks the overall clinical success and retention of the implant in the patient's mouth. The study actively monitors for adverse clinical signs that would indicate failure, such as implant mobility, pain, swelling, or active infection.
Time frame: The final survival rate is assessed 6 months after the implant has been loaded with the final prosthesis. Any implant showing signs of failure before loading is excluded from the final analysis.
Peri-implant Soft-Tissue Response
This outcome evaluates the health and stability of the gum tissues surrounding the dental implant after the artificial tooth has been attached.
Time frame: The primary evaluation is recorded 6 months after the final prosthesis is delivered. According to the participant timeline, periodontal probing is specifically conducted at Week 8 to 10, Week 20 to 22, and Week 32 to 34.
Marginal Bone Level Change
This outcome monitors the preservation or loss of the bone immediately surrounding the neck of the implant once it is bearing the chewing load (functional loading).
Time frame: X-rays are taken at 1, 3, and 6 months after the placement of the final prosthesis.
Started Apr 2026 (actual). Primary completion is estimated for Jan 2027, 9 months after the start.
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