CorrosionNCT06759870
'Evaluation of Photo-Functionalisation Effect on Dental Implants by ICP-MS'
An observational study of Corrosion, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Corrosion
- What is being tested?
- Collection of saliva, Collection of gingival samples and ISQ registration
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2025to 2 Jun 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Standard size implant
- Non-smoker
- No other metal-containing restorations in the mouth
Who cannot join
- Soft or hard tissue augmentation
- Use of short implants or implants of 4.5 mm or more
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 'Evaluation of the Effect of Increasing Surface Hydrophilicity by Photo-Functionalisation on Titanium Particle Release in Dental Implants by ICP-MS'
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.
Read more
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.
Read the detailed description
Nowadays, dental implants have become a common treatment for the removal of missing teeth. Studies on implant treatment have proven that titanium (Ti) implanted in bone continuously releases particles and significantly increases the total titanium content in the human body.
The two main reasons for the release of Ti particles from the implant are chemical corrosion and surface wear.
When the concentration of local titanium particles increases, oral intraepithelial haemostasis is damaged, inflammation in the surrounding tissues is exacerbated, and dynamic imbalance may occur in osteoblasts and osteoclasts . Ti ions and particles distributed in the human body are directly proportional to the distance from the implant. Concentration is higher in gingival and bone tissue adjacent to the implant.Recent publications in the dental implant literature have shown that treatment of dental implant titanium oxide (TiO) surfaces with 200-400 nm ultraviolet (UV) radiation can increase the bone-implant contact surface (BIC) after normal healing time. UV treatment induces energy to the surface electrons of TiO, and electron energy induces reactions to increase cell attachment and osteoblast contact. UV treatment acts mostly photochemically on titanium surfaces to increase hydrophilicity. UV treatment with this photo-functionalisation has been shown to increase biological reactivity and make the TiO surface attractive for cellular binding.
It has been shown that the hydrophilicity and electrical charge of the titanium surface play a key role in the initial attachment of cells to UV-treated titanium. The newly treated titanium surface is 'superhydrophilic'. This term is used when the contact angle of water to the surface is less than 5 degrees. Due to the ageing of titanium, the implant surface gradually becomes hydrophobic with a contact angle of more than 60 degrees after 4 weeks of treatment. However, it was observed that 5 minutes of UV exposure reduced the water contact angle to almost 0°. The main function of UV treatment is to change the surface from hydrophobic to superhydrophilic, with the removal of hydrocarbon contamination from the surface of titanium. This induced surface change increases the initial blood contact with the implant surface and facilitates cellular growth and osseointegration of bone to the implant. In fact, studies have shown that the bioactivity of UV-activated titanium surfaces is higher than the bioactivity of newly treated surfaces .
UV treatment of titanium surfaces increases the bone-implant contact area from 55% to close to 98.2% and also results in a 3-fold increase in the strength of bone-implant integration. This greatly improves primary stability even in implants placed without cortical bone support. Primary stability is very important to avoid micro-movements that may adversely affect the osseointegration process.
In the light of all this information, the aim of this study was to evaluate the effect of UV photo-functionalisation on titanium particle release in titanium implants.
- Conditions
- Corrosion
- Being tested
- Collection of saliva, Collection of gingival samples, ISQ registration
- Keywords
- corrosion, dental implant, photo-functionalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of salivaOther
An unstimulated saliva sample will be obtained for 1 minute before implant surgery and immediately after implant surgery.
Collection of gingival samplesOther
Gingival samples will be obtained by punch biopsy 3 months after implant surgery.
ISQ registrationOther
ISQ value will be record in placement dental implant.
| Study group | Role | What they receive |
|---|---|---|
| 1- Standart dental implant | Not described Receives: Other: Collection of saliva; Other: Collection of gingival samples; Other: ISQ registration | |
| 2-Photo-functionalization dental implant | Not described Receives: Other: Collection of saliva; Other: Collection of gingival samples; Other: ISQ registration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
ISQ (Implant stability quotient) result
ISQ values will be measured on the implant stability measurement device and expressed as numerical values.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start3 Feb 2025
- Primary completion15 Feb 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CorrosionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukran Acipinar, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759870
- Sponsor's protocol ID
- Şükran Acıpınar ICP-MS
- Other IDs
- Cübap
- Status last verified
- Jun 2026
- First submitted
- 20 Dec 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be uploaded to the system when the study is concluded.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Evaluation of the Effect of Increasing Surface Hydrophilicity by Photo-Functionalisation on Titanium Particle Release in Dental Implants by ICP-MS'
- ClinicalTrials.gov ID
- NCT06759870
- Acronym / sponsor ID
- Şükran Acıpınar ICP-MS
- Conditions
- Corrosion
- Keywords
- corrosion, dental implant, photo-functionalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nowadays, dental implants have become a common treatment for the removal of missing teeth. Studies on implant treatment have proven that titanium (Ti) implanted in bone continuously releases particles and significantly increases the total titanium content in the human body.
The two main reasons for the release of Ti particles from the implant are chemical corrosion and surface wear.
When the concentration of local titanium particles increases, oral intraepithelial haemostasis is damaged, inflammation in the surrounding tissues is exacerbated, and dynamic imbalance may occur in osteoblasts and osteoclasts . Ti ions and particles distributed in the human body are directly proportional to the distance from the implant. Concentration is higher in gingival and bone tissue adjacent to the implant.Recent publications in the dental implant literature have shown that treatment of dental implant titanium oxide (TiO) surfaces with 200-400 nm ultraviolet (UV) radiation can increase the bone-implant contact surface (BIC) after normal healing time. UV treatment induces energy to the surface electrons of TiO, and electron energy induces reactions to increase cell attachment and osteoblast contact. UV treatment acts mostly photochemically on titanium surfaces to increase hydrophilicity. UV treatment with this photo-functionalisation has been shown to increase biological reactivity and make the TiO surface attractive for cellular binding.
It has been shown that the hydrophilicity and electrical charge of the titanium surface play a key role in the initial attachment of cells to UV-treated titanium. The newly treated titanium surface is 'superhydrophilic'. This term is used when the contact angle of water to the surface is less than 5 degrees. Due to the ageing of titanium, the implant surface gradually becomes hydrophobic with a contact angle of more than 60 degrees after 4 weeks of treatment. However, it was observed that 5 minutes of UV exposure reduced the water contact angle to almost 0°. The main function of UV treatment is to change the surface from hydrophobic to superhydrophilic, with the removal of hydrocarbon contamination from the surface of titanium. This induced surface change increases the initial blood contact with the implant surface and facilitates cellular growth and osseointegration of bone to the implant. In fact, studies have shown that the bioactivity of UV-activated titanium surfaces is higher than the bioactivity of newly treated surfaces .
UV treatment of titanium surfaces increases the bone-implant contact area from 55% to close to 98.2% and also results in a 3-fold increase in the strength of bone-implant integration. This greatly improves primary stability even in implants placed without cortical bone support. Primary stability is very important to avoid micro-movements that may adversely affect the osseointegration process.
In the light of all this information, the aim of this study was to evaluate the effect of UV photo-functionalisation on titanium particle release in titanium implants.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Standard size implant
- Non-smoker
- No other metal-containing restorations in the mouth
Key exclusion criteria (2 listed)
- Soft or hard tissue augmentation
- Use of short implants or implants of 4.5 mm or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of salivaAn unstimulated saliva sample will be obtained for 1 minute before implant surgery and immediately after implant surgery. | Other | 1- Standart dental implant, 2-Photo-functionalization dental implant |
| Collection of gingival samplesGingival samples will be obtained by punch biopsy 3 months after implant surgery. | Other | 1- Standart dental implant, 2-Photo-functionalization dental implant |
| ISQ registrationISQ value will be record in placement dental implant. | Other | 1- Standart dental implant, 2-Photo-functionalization dental implant |
Primary outcome
ICP-MS (Inductively Coupled Plasma - Mass Spectrometer) results
Time frame: 3 months
The levels of titanium element will be measured on the ICP-MS device and the results will be expressed at ppb level.
ISQ (Implant stability quotient) result
Time frame: 3 months
ISQ values will be measured on the implant stability measurement device and expressed as numerical values.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data will be uploaded to the system when the study is concluded.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corrosion, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICP-MS (Inductively Coupled Plasma - Mass Spectrometer) results (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.