Investigation of the release of titanium ions from titanium oxide-coated dental prostheses

Investigation of the release rate of titanium in the oral environment from stainless steel fixed retainer wire coated with titanium oxide using vapor phase deposition method

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20241211064021N11

Enrollment

Registered

2025-11-03

Start date

2025-11-15

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental implant complications caused by corrosion or release of titanium ions. Other mechanical complication of breast prosthesis and implant, initial encounter

Interventions

Intervention 1: Intervention group: 15 patients whose lower jaws are fitted with a stainless steel fixed retainer wire coated with a thin layer of titanium dioxide (TiO2TiO 2) using the PVD method. In

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients in the orthodontic debonding stage and needing a retainer Avoid using antibiotics and antibacterial mouthwashes during treatment.

Exclusion criteria

Exclusion criteria: pregnant women People with diabetes

Design outcomes

Primary

Measure	Time frame
Cumulative rate of titanium ion release. Timepoint: Specific time intervals (e.g., days 1, 7, 14, 28) and study endpoints (e.g., months 1, 3, 6) to determine the rate of spread over time. Method of measurement: Atomic absorption spectroscopy (AAS) or inductively coupled plasma emission spectroscopy (ICP-OES). Samples are immersed in a simulated saliva medium (or cell culture medium) and the amount of Ti in the solution is measured.	—

Measure

Time frame

Cumulative rate of titanium ion release. Timepoint: Specific time intervals (e.g., days 1, 7, 14, 28) and study endpoints (e.g., months 1, 3, 6) to determine the rate of spread over time. Method of measurement: Atomic absorption spectroscopy (AAS) or inductively coupled plasma emission spectroscopy (ICP-OES). Samples are immersed in a simulated saliva medium (or cell culture medium) and the amount of Ti in the solution is measured.

—

Secondary

Measure	Time frame
Inflammatory response. Timepoint: Before the intervention (Baseline), and then 3 months and 6 months after prosthesis/implant placement. Method of measurement: Measuring the levels of pro-inflammatory cytokines and anti-inflammatory cytokines in patients' saliva/serum or in cell culture medium.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Saifi

Iran University of Medical Sciences

aliseyfi791027@gmail.com6517838678

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026