OsteolysisNCT06041828
Regular Home-use Dual Light Photodynamic Therapy in the Prevention of Osteolysis After Dental Implant Surgery
A study testing Lumoral Treatment and Standard oral hygiene in people with Osteolysis and Dental Implants, run by Koite Health Oy at 1 site in Finland.
Trial summary
The aim of the study is to determine whether regular use of the antibacterial, photodynamic, CE-marked Lumoral device reduces the risk of osteolysis after dental implant surgery. The study also aims to find out whether Lumoral treatment can replace the use of chlorhexidine. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteolysis, Dental Implants
- What is being tested?
- Lumoral Treatment and Standard oral hygiene
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2025to 31 Dec 2025
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of ≥ 18 years
- Generally healthy,
- At least one new implant inserted
- New implant inserted
- Agreement to participate in the study with a written consent form signed
Who cannot join
- Uncontrolled diabetes mellitus (DM)
- Active smoking
- Any significant systemic disease
- Immediate implantation after tooth extraction
- Use of antibiotics within 4 weeks week prior study
- Presence of any physical limitation or restriction that might restrict Lumoral use
- Pregnancy or lactation
- History of six months use of antimicrobials, bisphosphonates, or corticosteroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Regular Home-use Dual Light Photodynamic Therapy in the Prevention of Osteolysis After Dental Implant Surgery
The aim of the study is to determine whether regular use of the antibacterial, photodynamic, CE-marked Lumoral device reduces the risk of osteolysis after dental implant surgery. The study also aims to find out whether Lumoral treatment can replace the use of chlorhexidine. Subjects will be randomized into two groups (20 + 20 subjects) and all will be given individual guidance on maintaining good oral hygiene. The participants in the study group will also be given Lumoral appliances with instructions for use at home. The Lumoral device has been shown in previous studies to be safe to use and effective in eliminating harmful oral bacteria.
Read the detailed description
After a dental implant procedure, implant stability is crucial for the success of the implant. The initial stability of the implant is determined by various factors such as implant design, surgical technique, bone quality, and quantity.
During the implant procedure, the implant is placed into the jawbone and is in direct contact with the surrounding bone. Over time, the bone will grow and fuse with the implant surface in a process called osseointegration. The implant stability is evaluated immediately after the surgery by measuring the implant stability quotient (ISQ) using a device called an implant stability meter.
The ISQ value ranges from 0 to 100, with higher values indicating greater implant stability. In general, an ISQ value of 60 or higher is considered to be a good indicator of implant stability. If the initial ISQ value is low, the implant may be at risk of failure due to lack of stability, and additional measures may be necessary to promote osseointegration, such as using bone grafting materials or growth factors.
In the first few weeks after the implant procedure, the implant may experience some initial mobility due to the inflammatory response and remodeling of the bone around the implant. However, with time, the bone will grow and fuse with the implant, providing a stable foundation for dental restoration.
With proper implant placement and regular follow-up care, the incidence of osteolysis can be minimized. Maintaining good oral hygiene practices, such as regular brushing, flossing, and dental check-ups, can help reduce the risk of inflammatory changes around dental implants. In addition, patients are usually advised to avoid placing excessive force on the implant during the healing process to prevent any damage to the implant and to ensure successful osseointegration. For example, patients can be advised to have a soft food diet at least for a few days after the implant placement.
One of the key issues in maintaining good oral health is patient self-management. A new tool "Lumoral Treatment" has been introduced in order to enhance oral home care. The Lumoral Treatment is a CE-marked medical device developed to provide a potent, targeted antibacterial action on the dental plaque in a home environment. It is used together with the mechanical cleaning (such as toothbrushing) of teeth. The device mechanism of action is antibacterial photodynamic therapy (aPDT) and thus non-medicinal. The Lumoral Treatment includes a light-activated Lumorinse mouth rinse and a Lumoral light activator. Its effect is based on a photodynamic method where the light-sensitive substance - indocyanine green - contained in the Lumorinse mouth rinse is attached to the bacterial film (plaque) and is activated by antibacterial dual light with 405 and 810 nanometers (nm).
The 810 nm light can also have a photobiomodulation effect in promoting bone growth and regeneration. Photobiomodulation (PBM) is a non-invasive therapy that uses low-level light therapy (LLLT) to stimulate cellular function and enhance tissue repair. Near-infrared (NIR) light is one of the commonly used wavelengths for PBM due to its ability to penetrate deeper into tissues. In the case of dental bone, PBM with NIR light has shown promising effects in promoting bone growth and regeneration. In dental applications, PBM with NIR light has shown promise in promoting bone growth and regeneration in cases of dental implant placement, tooth extraction, and periodontal disease.
- Conditions
- Osteolysis, Dental Implants
- Being tested
- Lumoral Treatment, Standard oral hygiene
- Keywords
- Lumoral, Dental implant, Osteolysis, Anti-bacterial photodynamic therapy, Oral hygiene
- Medical subject headings
- Osteolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumoral TreatmentDevice
Photodynamic antibacterial dual-light device with a marker substance
Standard oral hygieneOther
Standard oral hygiene instructions
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Standard oral hygiene and Lumoral Treatment home-use Receives: Device: Lumoral Treatment; Other: Standard oral hygiene |
| Control group | Active comparator | Standard oral hygiene only Receives: Other: Standard oral hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of osteolysis around dental implants
Assessing overall number of study subject that have developed osteolysis
Measured: 4 months
Secondary outcomes (3)
Active matrix metalloproteinase 8 (aMMP-8)
Change in periodontal inflammation marker aMMP-8. The aMMP-8 marker analysis will be performed using Periosafe chairside test (Dentognostics GmbH) according to the manufacturer's instructions.
Measured: 4 months
Bleeding on probing (BOP)
Change in bleeding on probing (BOP)
A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent" BOP is reported as the percentage (%) of sites with positive findings Calculation formula: number of bleeding sites/ 6 times number of teeth
Measured: 4 months
Probing Pocket Depth (PPD)
Change in the Probing Pocket Depth (PPD)
A full-mouth assessment, measured at 4 sites per tooth Assessed from the base of the pocket to the gingival margin (mm)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study startDec 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: The study has been temporarily halted due to time constraints at the study site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for OsteolysisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical study on a medical device.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koite Health Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hammaslääkärit Eteläranta 10, University of Helsinki
- Responsible party
- Sponsor
- Investigators
- Timo Sorsa, Professor, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041828
- Sponsor's protocol ID
- LumOsteo
- Status last verified
- Nov 2024
- First submitted
- 11 Sep 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dompe C, Moncrieff L, Matys J, Grzech-Lesniak K, Kocherova I, Bryja A, Bruska M, Dominiak M, Mozdziak P, Skiba THI, Shibli JA, Angelova Volponi A, Kempisty B, Dyszkiewicz-Konwinska M. Photobiomodulation-Underlying Mechanism and Clinical Applications. J Clin Med. 2020 Jun 3;9(6):1724. doi: 10.3390/jcm9061724.
PubMed 32503238Gupta R, Gupta N, Weber, DDS KK. Dental Implants. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470448/
PubMed 29262027H H, G W, E H. The clinical significance of implant stability quotient (ISQ) measurements: A literature review. J Oral Biol Craniofac Res. 2020 Oct-Dec;10(4):629-638. doi: 10.1016/j.jobcr.2020.07.004. Epub 2020 Aug 14.
PubMed 32983857Nikinmaa S, Moilanen N, Sorsa T, Rantala J, Alapulli H, Kotiranta A, Auvinen P, Kankuri E, Meurman JH, Patila T. Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque. Dent J (Basel). 2021 May 3;9(5):52. doi: 10.3390/dj9050052.
PubMed 34063662Pandey C, Rokaya D, Bhattarai BP. Contemporary Concepts in Osseointegration of Dental Implants: A Review. Biomed Res Int. 2022 Jun 14;2022:6170452. doi: 10.1155/2022/6170452. eCollection 2022.
PubMed 35747499Swami V, Vijayaraghavan V, Swami V. Current trends to measure implant stability. J Indian Prosthodont Soc. 2016 Apr-Jun;16(2):124-30. doi: 10.4103/0972-4052.176539.
PubMed 27141160Qu C, Luo F, Hong G, Wan Q. Effects of photobiomodulation therapy on implant stability and postoperative recovery: a systematic review and meta-analysis. Br J Oral Maxillofac Surg. 2022 Jun;60(5):e712-e721. doi: 10.1016/j.bjoms.2022.01.014. Epub 2022 Feb 5.
PubMed 35490059Wang Y, Zhang Y, Miron RJ. Health, Maintenance, and Recovery of Soft Tissues around Implants. Clin Implant Dent Relat Res. 2016 Jun;18(3):618-34. doi: 10.1111/cid.12343. Epub 2015 Apr 15.
PubMed 25873299
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Regular Home-use Dual Light Photodynamic Therapy in the Prevention of Osteolysis After Dental Implant Surgery
- ClinicalTrials.gov ID
- NCT06041828
- Acronym / sponsor ID
- LumOsteo
- Conditions
- Osteolysis, Dental Implants
- Keywords
- Lumoral, Dental implant, Osteolysis, Anti-bacterial photodynamic therapy, Oral hygiene
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study has been temporarily halted due to time constraints at the study site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Koite Health OyIndustry (pharma, biotech, devices)
- Collaborators
- Hammaslääkärit Eteläranta 10, University of Helsinki
- Study start
- Dec 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Sep 2023 (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.
The aim of the study is to determine whether regular use of the antibacterial, photodynamic, CE-marked Lumoral device reduces the risk of osteolysis after dental implant surgery. The study also aims to find out whether Lumoral treatment can replace the use of chlorhexidine. Subjects will be randomized into two groups (20 + 20 subjects) and all will be given individual guidance on maintaining good oral hygiene. The participants in the study group will also be given Lumoral appliances with instructions for use at home. The Lumoral device has been shown in previous studies to be safe to use and effective in eliminating harmful oral bacteria.
Detailed description
After a dental implant procedure, implant stability is crucial for the success of the implant. The initial stability of the implant is determined by various factors such as implant design, surgical technique, bone quality, and quantity.
During the implant procedure, the implant is placed into the jawbone and is in direct contact with the surrounding bone. Over time, the bone will grow and fuse with the implant surface in a process called osseointegration. The implant stability is evaluated immediately after the surgery by measuring the implant stability quotient (ISQ) using a device called an implant stability meter.
The ISQ value ranges from 0 to 100, with higher values indicating greater implant stability. In general, an ISQ value of 60 or higher is considered to be a good indicator of implant stability. If the initial ISQ value is low, the implant may be at risk of failure due to lack of stability, and additional measures may be necessary to promote osseointegration, such as using bone grafting materials or growth factors.
In the first few weeks after the implant procedure, the implant may experience some initial mobility due to the inflammatory response and remodeling of the bone around the implant. However, with time, the bone will grow and fuse with the implant, providing a stable foundation for dental restoration.
With proper implant placement and regular follow-up care, the incidence of osteolysis can be minimized. Maintaining good oral hygiene practices, such as regular brushing, flossing, and dental check-ups, can help reduce the risk of inflammatory changes around dental implants. In addition, patients are usually advised to avoid placing excessive force on the implant during the healing process to prevent any damage to the implant and to ensure successful osseointegration. For example, patients can be advised to have a soft food diet at least for a few days after the implant placement.
One of the key issues in maintaining good oral health is patient self-management. A new tool "Lumoral Treatment" has been introduced in order to enhance oral home care. The Lumoral Treatment is a CE-marked medical device developed to provide a potent, targeted antibacterial action on the dental plaque in a home environment. It is used together with the mechanical cleaning (such as toothbrushing) of teeth. The device mechanism of action is antibacterial photodynamic therapy (aPDT) and thus non-medicinal. The Lumoral Treatment includes a light-activated Lumorinse mouth rinse and a Lumoral light activator. Its effect is based on a photodynamic method where the light-sensitive substance - indocyanine green - contained in the Lumorinse mouth rinse is attached to the bacterial film (plaque) and is activated by antibacterial dual light with 405 and 810 nanometers (nm).
The 810 nm light can also have a photobiomodulation effect in promoting bone growth and regeneration. Photobiomodulation (PBM) is a non-invasive therapy that uses low-level light therapy (LLLT) to stimulate cellular function and enhance tissue repair. Near-infrared (NIR) light is one of the commonly used wavelengths for PBM due to its ability to penetrate deeper into tissues. In the case of dental bone, PBM with NIR light has shown promising effects in promoting bone growth and regeneration. In dental applications, PBM with NIR light has shown promise in promoting bone growth and regeneration in cases of dental implant placement, tooth extraction, and periodontal disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical study on a medical device.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Lumoral Treatment, Other: Standard oral hygieneStandard oral hygiene and Lumoral Treatment home-use |
| Control group | Active comparator | Other: Standard oral hygieneStandard oral hygiene only |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of ≥ 18 years
- Generally healthy,
- At least one new implant inserted
- New implant inserted
- Agreement to participate in the study with a written consent form signed
Key exclusion criteria (8 listed)
- Uncontrolled diabetes mellitus (DM)
- Active smoking
- Any significant systemic disease
- Immediate implantation after tooth extraction
- Use of antibiotics within 4 weeks week prior study
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 |
|---|---|---|
| Lumoral TreatmentPhotodynamic antibacterial dual-light device with a marker substance | Device | Study group |
| Standard oral hygieneStandard oral hygiene instructions | Other | Control group, Study group |
Primary outcome
Incidence of osteolysis around dental implants
Time frame: 4 months
Assessing overall number of study subject that have developed osteolysis
3 secondary outcomes
Active matrix metalloproteinase 8 (aMMP-8)
Time frame: 4 months
Bleeding on probing (BOP)
Time frame: 4 months
Probing Pocket Depth (PPD)
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 32503238Dompe C, Moncrieff L, Matys J, Grzech-Lesniak K, Kocherova I, Bryja A, Bruska M, Dominiak M, Mozdziak P, Skiba THI, Shibli JA, Angelova Volponi A, Kempisty B, Dyszkiewicz-Konwinska M. Photobiomodulation-Underlying Mechanism and Clinical Applications. J Clin Med. 2020 Jun 3;9(6):1724. doi: 10.3390/jcm9061724.
- Background: PubMed 29262027Gupta R, Gupta N, Weber, DDS KK. Dental Implants. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470448/
- Background: PubMed 32983857H H, G W, E H. The clinical significance of implant stability quotient (ISQ) measurements: A literature review. J Oral Biol Craniofac Res. 2020 Oct-Dec;10(4):629-638. doi: 10.1016/j.jobcr.2020.07.004. Epub 2020 Aug 14.
- Background: PubMed 34063662Nikinmaa S, Moilanen N, Sorsa T, Rantala J, Alapulli H, Kotiranta A, Auvinen P, Kankuri E, Meurman JH, Patila T. Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque. Dent J (Basel). 2021 May 3;9(5):52. doi: 10.3390/dj9050052.
- Background: PubMed 35747499Pandey C, Rokaya D, Bhattarai BP. Contemporary Concepts in Osseointegration of Dental Implants: A Review. Biomed Res Int. 2022 Jun 14;2022:6170452. doi: 10.1155/2022/6170452. eCollection 2022.
- Background: PubMed 27141160Swami V, Vijayaraghavan V, Swami V. Current trends to measure implant stability. J Indian Prosthodont Soc. 2016 Apr-Jun;16(2):124-30. doi: 10.4103/0972-4052.176539.
- Background: PubMed 35490059Qu C, Luo F, Hong G, Wan Q. Effects of photobiomodulation therapy on implant stability and postoperative recovery: a systematic review and meta-analysis. Br J Oral Maxillofac Surg. 2022 Jun;60(5):e712-e721. doi: 10.1016/j.bjoms.2022.01.014. Epub 2022 Feb 5.
- Background: PubMed 25873299Wang Y, Zhang Y, Miron RJ. Health, Maintenance, and Recovery of Soft Tissues around Implants. Clin Implant Dent Relat Res. 2016 Jun;18(3):618-34. doi: 10.1111/cid.12343. Epub 2015 Apr 15.
- Amengual-Peñafiel. Osteoimmunology drives dental implant osseointegration: A new paradigm for implant dentistry. Japanese Dental Science Review 57 (2021) 12-19.Link provided by the sponsor.
- Elias. Factors Affecting the Success of Dental Implants. Implant dentistry, Aug 2011. DOI: 10.5772/18746Link provided by the sponsor.
- Gupta et al. Implant Stability Quotient (ISQ): A Reliable Guide for Implant Treatment. Current Concepts in Dental Implantology. 2021. DOI: 10.5772/intechopen.101359Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Timo Sorsa, Professor principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumoral Treatment and Standard oral hygiene in people with Osteolysis and Dental Implants, run by Koite Health Oy at 1 site in Finland.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 19 Nov 2024. 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 Finland. 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of osteolysis around dental implants (time frame: 4 months). 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 NCT06041828, which also lists 8 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 19 Nov 2024.