Dental ImplantsNCT06821932
Evaluation of the Bone Structure Surrounding Photofunctionalized Implants
A study testing Photofunctionalized dental implant surgery and Dental implant surgery in people with Dental Implants, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Bacground: Implant failure may necessitate the need for another surgical procedure to improve implant survival. Photofunctionalization with UV is a practice that can positively affect dental implant success and osseointegration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- Photofunctionalized dental implant surgery and Dental implant surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2021to 22 Oct 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over the age of 18
- Having bilateral edentulous areas in the posterior mandibular region
Who cannot join
- Individuals with any systemic disease,
- Individuals using drugs that affect bone metabolism,
- Patients with findings that could affect the study results such as bone cysts, tumors, lesions or fractures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University, Faculty of Dentistry
Ankara, Yenimahalle, 06500
About this study
Official title: Evaluation of the Bone Structure Surrounding Photofunctionalized Implants Using the Fractal Analysis Method: A Split-mouth Randomised Clinical Trial
Bacground: Implant failure may necessitate the need for another surgical procedure to improve implant survival. Photofunctionalization with UV is a practice that can positively affect dental implant success and osseointegration. The aim of this study is to evaluate the effect of the photofunctionalization process on the bone quality around the implant.
Methods: In the study, 42 implants were evaluated using the Fractal Analysis method from the panoramic radiographs taken before and after the implant. The analysis of the data was done with the SPSS 26 program and worked with a 95% confidence level. In the test group, there was a statistically significant difference between the 1st panoramic measurement and the 2nd panoramic measurement (p=0.044<0.05) and the bone fractal score increased.
Read the detailed description
Bacground: Implant failure may necessitate the need for another surgical procedure to improve implant survival. Photofunctionalization with UV is a practice that can positively affect dental implant success and osseointegration. The aim of this study is to evaluate the effect of the photofunctionalization process on the bone quality around the implant.
Methods: In the study, 42 implants were evaluated using the Fractal Analysis method from the panoramic radiographs taken before and after the implant. The analysis of the data was done with the SPSS 26 program and worked with a 95% confidence level. In the test group, there was a statistically significant difference between the 1st panoramic measurement and the 2nd panoramic measurement (p=0.044<0.05) and the bone fractal score increased.
- Conditions
- Dental Implants
- Being tested
- Photofunctionalized dental implant surgery, Dental implant surgery
- Keywords
- Photofunctionalization, Ultraviyolet Light, Dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photofunctionalized dental implant surgeryProcedure or surgery
Dental implants subjected to photofunctionalization were placed in the experimental area of the mouth.
Dental implant surgeryProcedure or surgery
Dental implants not subjected to photofunctionalization were placed in the bone on the contralateral side of the mouth
| Study group | Role | What they receive |
|---|---|---|
| Experimental: photofunctionalized implant inserted | Experimental | Dental implants were subjected to the photofunctionalization process and then immediately inserted into the bone on the experimental side of the mouth Receives: Procedure: Photofunctionalized dental implant surgery |
| Control: Dental implant placement without photofunctionalization process | Active comparator | Dental implants were inserted in the bone on the contralateral side of the mouth without photofunctionalization Receives: Procedure: Dental implant surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone fractal analysis
The bone fractal dimension (FB) values were determined by sizing the ROI to 25x25 pixels using the box counting method. The area of interest to be examined in the image was cropped and saved in 8-bit format. Different image processing methods were applied. For the fractal dimension calculation the box counting method was used. The number of squares containing trabeculae and the total number of squares in the image were determined for various pixel sizes. These values were plotted on a logarithmic scale, and the slope of the line that best fit the points on the graph determined the bone FB.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start15 May 2021
- Primary completion10 Jun 2022
- Study completion22 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Splith mouth
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Karacaoğlu, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821932
- Sponsor's protocol ID
- 36290600/34/2021
- Status last verified
- Apr 2021
- First submitted
- 3 Jan 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Choi B, Lee YC, Oh KC, Lee JH. Effects of photofunctionalization on early osseointegration of titanium dental implants in the maxillary posterior region: a randomized double-blinded clinical trial. Int J Implant Dent. 2021 May 10;7(1):37. doi: 10.1186/s40729-021-00318-x.
PubMed 33969450Hirota M, Ozawa T, Iwai T, Ogawa T, Tohnai I. Effect of Photofunctionalization on Early Implant Failure. Int J Oral Maxillofac Implants. 2018 Sep/Oct;33(5):1098-1102. doi: 10.11607/jomi.6541.
PubMed 30231097Farsiani H, Bagis N, Balkan EP, Karacaoglu F, Guner ZD, Orhan K. Evaluation of the bone structure surrounding photofunctionalized implants using the fractal analysis method: a split-mouth randomized clinical study. BMC Oral Health. 2025 Jul 1;25(1):964. doi: 10.1186/s12903-025-06330-6.
PubMed 40598042
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Bone Structure Surrounding Photofunctionalized Implants Using the Fractal Analysis Method: A Split-mouth Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06821932
- Acronym / sponsor ID
- 36290600/34/2021
- Conditions
- Dental Implants
- Keywords
- Photofunctionalization, Ultraviyolet Light, Dental implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 22 Oct 2022 (actual)
- First posted
- 12 Feb 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.
Bacground: Implant failure may necessitate the need for another surgical procedure to improve implant survival. Photofunctionalization with UV is a practice that can positively affect dental implant success and osseointegration. The aim of this study is to evaluate the effect of the photofunctionalization process on the bone quality around the implant.
Methods: In the study, 42 implants were evaluated using the Fractal Analysis method from the panoramic radiographs taken before and after the implant. The analysis of the data was done with the SPSS 26 program and worked with a 95% confidence level. In the test group, there was a statistically significant difference between the 1st panoramic measurement and the 2nd panoramic measurement (p=0.044<0.05) and the bone fractal score increased.
Detailed description
Bacground: Implant failure may necessitate the need for another surgical procedure to improve implant survival. Photofunctionalization with UV is a practice that can positively affect dental implant success and osseointegration. The aim of this study is to evaluate the effect of the photofunctionalization process on the bone quality around the implant.
Methods: In the study, 42 implants were evaluated using the Fractal Analysis method from the panoramic radiographs taken before and after the implant. The analysis of the data was done with the SPSS 26 program and worked with a 95% confidence level. In the test group, there was a statistically significant difference between the 1st panoramic measurement and the 2nd panoramic measurement (p=0.044<0.05) and the bone fractal score increased.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Splith mouth
| Arm | Type | Receives |
|---|---|---|
| Experimental: photofunctionalized implant inserted | Experimental | Procedure: Photofunctionalized dental implant surgeryDental implants were subjected to the photofunctionalization process and then immediately inserted into the bone on the experimental side of the mouth |
| Control: Dental implant placement without photofunctionalization process | Active comparator | Procedure: Dental implant surgeryDental implants were inserted in the bone on the contralateral side of the mouth without photofunctionalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being over the age of 18
- Having bilateral edentulous areas in the posterior mandibular region
Key exclusion criteria (3 listed)
- Individuals with any systemic disease,
- Individuals using drugs that affect bone metabolism,
- Patients with findings that could affect the study results such as bone cysts, tumors, lesions or fractures
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 |
|---|---|---|
| Photofunctionalized dental implant surgeryDental implants subjected to photofunctionalization were placed in the experimental area of the mouth. | Procedure or surgery | Experimental: photofunctionalized implant inserted |
| Dental implant surgeryDental implants not subjected to photofunctionalization were placed in the bone on the contralateral side of the mouth | Procedure or surgery | Control: Dental implant placement without photofunctionalization process |
Primary outcome
Bone fractal analysis
Time frame: 1 month
The bone fractal dimension (FB) values were determined by sizing the ROI to 25x25 pixels using the box counting method. The area of interest to be examined in the image was cropped and saved in 8-bit format. Different image processing methods were applied. For the fractal dimension calculation the box counting method was used. The number of squares containing trabeculae and the total number of squares in the image were determined for various pixel sizes. These values were plotted on a logarithmic scale, and the slope of the line that best fit the points on the graph determined the bone FB.
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 12 Feb 2025.
- Results publication: PubMed 33969450Choi B, Lee YC, Oh KC, Lee JH. Effects of photofunctionalization on early osseointegration of titanium dental implants in the maxillary posterior region: a randomized double-blinded clinical trial. Int J Implant Dent. 2021 May 10;7(1):37. doi: 10.1186/s40729-021-00318-x.
- Results publication: PubMed 30231097Hirota M, Ozawa T, Iwai T, Ogawa T, Tohnai I. Effect of Photofunctionalization on Early Implant Failure. Int J Oral Maxillofac Implants. 2018 Sep/Oct;33(5):1098-1102. doi: 10.11607/jomi.6541.
- Derived from this study: PubMed 40598042Farsiani H, Bagis N, Balkan EP, Karacaoglu F, Guner ZD, Orhan K. Evaluation of the bone structure surrounding photofunctionalized implants using the fractal analysis method: a split-mouth randomized clinical study. BMC Oral Health. 2025 Jul 1;25(1):964. doi: 10.1186/s12903-025-06330-6.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Implants
Not yet recruitingObservational study
Association Between Peri-implant Tissue Health and Crown Shape: a Prospective Study
Dental Implants
Not yet recruitingPhase 4
S-TiUltra Implant Study
Missing Tooth/Teeth
Recruiting
Surgical Guide Versus Freehand Dental Implants Placement
Dental Implant Placement
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Recruiting
Dental Implant Healing With TNF-Alpha Inhibitors
Dental Implants, TNF-alpha Inhibitors
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?
A study testing Photofunctionalized dental implant surgery and Dental implant surgery in people with Dental Implants, run by Ankara 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 2 inclusion and 3 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 12 Feb 2025. 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?
Bone fractal analysis (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06821932, which also lists 3 linked publications.
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 12 Feb 2025.