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

NCT07868744 | Active Not Recruiting DMC

• 1 other identifier: FUE.REC (33)/3-2026
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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; Determining the Feasibility and Success Rate of an Accelerated "Early Loading" Protocol; Assessing the Survival Rate of the Implants, Along With the Peri-implant Soft Tissue Response and Marginal Bone Preservation

Keywords

UV Photofunctionalization (phF); Ultraviolet (UV) surface treatment; Early loading; Titanium aging; Superhydrophilic implant; Ultraviolet (UV)

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (3)

• Assessing the overall survival and success of the implants at 6 months after functional loading.

  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

  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

  X-rays are taken at 1, 3, and 6 months after the placement of the final prosthesis.

Study Arms (1)

UV-Photofunctionalized Titanium Implants

EXPERIMENTAL

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

Interventions

UV-photofunctionalized titanium dental implants DEVICE

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

UV-Photofunctionalized Titanium Implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years of age.
• Patients with single or multiple missing teeth in a healed edentulous ridge located in the mandibular posterior area.
• Patients classified as having D2 or D3 bone quality based on pre-operative CBCT scans.
• Patients possessing sufficient bone volume for implant placement without the need for major grafting procedures.
• Patients demonstrating good oral hygiene and compliance.

You may not qualify if:

• Uncontrolled systemic diseases.
• Bone quality of D1 or D4.
• Smoking \>10 cigarettes/day.
• Active infection or periodontal disease.
• Need for extensive bone augmentation.
• Pregnancy or lactation.
• Parafunctional habits.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future university hospital

Cairo, Fifth Settlement, 11835, Egypt

Location

Related Publications (13)

• Al-Hity TR, El-Dhuwaib B, Al-Zahawi AR, Gul SS. Comparison of primary and secondary stability of a one-piece compressive conometric implant system in the posterior upper and lower jaws. Front Oral Health. 2025 Jul 25;6:1625593. doi: 10.3389/froh.2025.1625593. eCollection 2025.

  PMID: 40786186 RESULT

• Sandhu S, et al.; Impact of UV-Photofunctionalization on Marginal Bone Loss around Dental Implants: A 3-year Clinical Follow-up; Clin Oral Implants Res; 2022; 33(S24); 118.

  RESULT

• Sanchez-Perez A, Cachazo-Jimenez C, Sanchez-Matas C, Martin-de-Llano JJ, Davis S, Carda-Batalla C. Effects of Ultraviolet Photoactivation on Osseointegration of Commercial Pure Titanium Dental Implant After 8 Weeks in a Rabbit Model. J Oral Implantol. 2020 Apr 1;46(2):101-107. doi: 10.1563/aaid-joi-D-19-00122.

  PMID: 31905048 RESULT

• Liu Y, et al.; Role of Photofunctionalization in Orthopedic and Dental Customized Implants: A Review of Bio-Integration; Bio-Integration; 2025; 6(1); 0094.

  RESULT

• Funato A, Ogawa T; Photofunctionalized implants: A clinical breakthrough in healing time and success rate; Int J Oral Maxillofac Implants; 2023; 38(4); 1263-1272.

  RESULT

• Al-Obaidi MH, et al.; Evaluating dental implant stability using three devices Osstell, Periotest, and AnyCheck: a clinical study; J Baghdad Coll Dent; 2024; 36(3); 14-22.

  RESULT

• Chacko A, Varghese S, et al.; Enhancing osseointegration: A comprehensive review of UV photofunctionalization for titanium dental implants; IP Ann Prosthodont Restor Dent; 2025; 11(2); 107-114.

  RESULT

• Yamuna R, Keerthivasan MS, Narasimman M, Tamizhesai B, Venkatakrishnan CJ; Photofunctionalization of dental implants - A literature review; Indian J Dent Sci; 2025; 17; 95-103.

  RESULT

• Razali M, Ngeow WC, Omar RA, Chai WL; An Integrated Overview of Ultraviolet Technology for Reversing Titanium Dental Implant Degradation: Mechanism of Reaction and Effectivity; Appl Sci; 2020; 10(1654); 1-23.

  RESULT

• Lang X, Qiao B, Ge Z, Yan J, Zhang Y. Clinical Effects of Photofunctionalization on Implant Stability and Marginal Bone Loss: Systematic Review and Meta-Analysis. J Clin Med. 2022 Nov 28;11(23):7042. doi: 10.3390/jcm11237042.

  PMID: 36498616 RESULT

• Ghambaryan N, Jilavyan A, Burnazyan S, Khudaverdyan M, Gegham T, Hakobyan G. Clinical Outcome of Immediate Loading UV-Photofunctionalized Implants in Patients with Completely Edentulous Mandible, Placed with Guided Surgery. J Maxillofac Oral Surg. 2023 Mar;22(Suppl 1):64-75. doi: 10.1007/s12663-022-01798-z. Epub 2022 Dec 15.

  PMID: 37041958 RESULT

• Arroyo-Lamas N, Arteagoitia I, Ugalde U. Surface Activation of Titanium Dental Implants by Using UVC-LED Irradiation. Int J Mol Sci. 2021 Mar 5;22(5):2597. doi: 10.3390/ijms22052597.

  PMID: 33807532 RESULT

• Houshmand B, Rezaei Esfahroodi Z, Behnamghader A, Mohammadreza S, Azizi A, Ramezani K. Evaluation of UV photofunctionalization effect on ultrastructural properties of SLA titanium disks: An in vitro study. J Adv Periodontol Implant Dent. 2023 Sep 11;15(2):117-122. doi: 10.34172/japid.2023.015. eCollection 2023.

  PMID: 38357335 RESULT

Related Links

• Relevance: This is the official website of the university and faculty where the principal investigator, supervisors, and the Department of Oral \& Maxillofacial Surgery are based, and where the ethics committee approval will take place.
• Relevance: This is the manufacturer of the Point UV® Implant System (Titanium Grade 4) specified in the intervention section of your protocol. Their site contains technical specifications regarding their implant surfaces and UV activation devices.
• Relevance: Neobiotech is the manufacturer of the AnyCheck® device used for the primary outcome measurement in your study. The site explains the mechanics of the magnetic percussion method and how it measures Implant Stability Test (IST) values without re

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Model Details: The primary purpose of this study is to evaluate the implant stability and the feasibility of early loading for UV-photofunctionalized (UV-phF) titanium implants at 4 to 6 weeks post-placement in the D2/D3 bone of the posterior mandible.

Study Record Dates

• First Submitted: October 4, 2026
• First Posted: October 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

EG (1)