'Evaluation of Photo-Functionalisation Effect on Dental Implants by ICP-MS'

NCT06759870 | Active Not Recruiting

• 2 other identifiers: Şükran Acıpınar ICP-MSCübap
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Dental implants are used to rehabilitate and restore aesthetic and functional losses caused by tooth loss. They are made of titanium, which is considered to have the best biological safety as a material. However, it is known that implants can continuously corrode, releasing titanium particles and increasing the overall titanium content in the human body. This increased local concentration can lead to damage in intraepithelial hemostasis, exacerbation of inflammatory reactions in surrounding tissues, bone resorption, implant failure, allergic reactions, and accumulation in distal organs through blood and lymph pathways. The surface properties of implants play a critical role in their corrosion behavior, with surface free energy and hydrophilicity providing advantages for implant osseointegration and wound healing. The titanium oxide layer covers the outer surface of the implant and helps maintain its integrity against external factors. It is known that UV light-mediated photo-functionalization reduces carbon concentration on the implant surface and increases oxygen levels, thereby improving the osseointegration of titanium. The hydroxylated oxide surface shows reactivity with ions, amino acids, and proteins in tissue fluid. Additionally, UV irradiation can create oxygen vacancies at bridging sites between titanium and oxygen atoms, forming a -OH hydrophilic layer in the outermost layer. Given that the oxide layer on the titanium surface provides corrosion resistance for implants, increasing surface hydrophilicity and thus strengthening osseointegration will also confer resistance to corrosion on titanium. Although the mechanism of titanium particle release is not fully understood, it is influenced by the surface structure of the implant and wear from surgical operations, making it a concern that needs to be addressed. In light of all this information, the aim of the study was to evaluate titanium particle release in implants with increased surface hydrophilicity by UV photofunctionalization during surgery and three months later during the healing process using ICP-MS.

Conditions

Corrosion

Keywords

corrosion; dental implant; photo-functionalization

Outcome Measures

Primary Outcomes (2)

• ICP-MS (Inductively Coupled Plasma - Mass Spectrometer) results

  The levels of titanium element will be measured on the ICP-MS device and the results will be expressed at ppb level.

  3 months

• ISQ (Implant stability quotient) result

  ISQ values will be measured on the implant stability measurement device and expressed as numerical values.

  3 months

Study Arms (2)

1- Standart dental implant

Other: Collection of saliva; Other: Collection of gingival samples; Other: ISQ registration

2-Photo-functionalization dental implant

Other: Collection of saliva; Other: Collection of gingival samples; Other: ISQ registration

Interventions

Collection of saliva OTHER

An unstimulated saliva sample will be obtained for 1 minute before implant surgery and immediately after implant surgery.

1- Standart dental implant; 2-Photo-functionalization dental implant

ISQ registration OTHER

ISQ value will be record in placement dental implant.

1- Standart dental implant; 2-Photo-functionalization dental implant

Collection of gingival samples OTHER

Gingival samples will be obtained by punch biopsy 3 months after implant surgery.

1- Standart dental implant; 2-Photo-functionalization dental implant

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People between the ages of 35-65 who had dental implants and who did not have any systemic diseases constitute the population of our study.

You may qualify if:

• Standard size implant
• Non-smoker
• No other metal-containing restorations in the mouth

You may not qualify if:

• Soft or hard tissue augmentation
• Use of short implants or implants of 4.5 mm or more

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Sivas, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva and gingival samples

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof. Şükran ACIPINAR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 6, 2025
• Study Start: February 3, 2025
• Primary Completion: February 15, 2026
• Study Completion (Estimated): June 2, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Once the study is published, it is planned to remain in the system for 1 year.
• Access Criteria: The study protocol may be made available publicly.

Locations

TU (1)