Peri-ImplantitisNCT06017817
Antibacterial Photodynamic Therapy in the Management of Peri-implantitis
A study testing Lumoral Treatment, Standard oral hygiene instructions and Scaling and root planing (SRP in people with Peri-Implantitis and Plaque, Dental, run by Koite Health Oy at 1 site in Sweden.
Trial summary
This early-stage study is designed to determine the efficacy of the Lumoral method in periimplantitis. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peri-Implantitis, Plaque, Dental
- What is being tested?
- Lumoral Treatment, Standard oral hygiene instructions and Scaling and root planing (SRP
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 13 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- PPD ≥6 mm and marginal bone loss >3 mm
- Dental implants collected and clinically characterized according to Lähteenmäki et al. CEDR-22
- Agreement to participate in the study and to sign a written consent form
- Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol
Who cannot join
- Presence of any physical limitation or restriction that might restrict Lumoral use
- Unwilling to participate in the study
- Pregnancy or lactation
- Active smoking
- Medicated diabetes mellitus (DM)
- Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of peri-implantitis
Show all 9Show fewer
- Use of antibiotics and doxycycline, chlorhexidine, and bisphosphonates, within 4 weeks week prior to study participation
- Peri-implant and periodontal treatment within 3 months prior to study participation
- Removable major prosthesis or major orthodontic appliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Södertandläkarna AB
Stockholm, 11622
Nilminie Rathnayake, Periodontist
About this study
Official title: Regular Home-use of Antibacterial Photodynamic Therapy in the Management of Peri-implantitis
This early-stage study is designed to determine the efficacy of the Lumoral method in periimplantitis. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues, thus impacting osseointegration.
Read the detailed description
Clinical signs of inflammation in peri-implantitis include bleeding on probing, suppuration, increased probing depth, and radiographic signs of bone loss. Currently, the best treatment options for peri-implantitis include non-surgical methods of biofilm removal in the supra-mucosal area around implants, and comprehensive guidance on self-performed infection control procedures. With more advanced peri-implantitis, anti-infective surgical treatment protocol would be needed.
Matrix metalloproteinase 8 (MMP-8) has been found to be elevated in association with oral infections, such as periodontitis and peri-implantitis. The level of active MMP-8 (aMMP-8) can detect to determine tissue health and to assess inflammation, and can easily be measured during a regular dental appointment with a chairside test.
The Lumoral Treatment is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The method mechanism of action is antibacterial photodynamic therapy (aPDT). The method is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.
- Conditions
- Peri-Implantitis, Plaque, Dental
- Being tested
- Lumoral Treatment, Standard oral hygiene instructions, Scaling and root planing (SRP, surgical anti-infective peri-implantitis treatment
- Keywords
- Lumoral, Lumorinse, Antibacterial photodynamic therapy (aBPT), aMMP-8, Plaque control
- Medical subject headings
- Peri-Implantitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumoral TreatmentDevice
Anti-infective photodynamic therapy for plaque-induced oral conditions
Standard oral hygiene instructionsProcedure or surgery
Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use
Scaling and root planing (SRPProcedure or surgery
non-surgical anti-infective treatment by scaling and root planing
surgical anti-infective peri-implantitis treatmentProcedure or surgery
surgical anti-infective peri-implantitis treatment
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical treatment, Study group (NST-1) | Experimental | Lumoral Treatment; Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use. Receives: Device: Lumoral Treatment; Procedure: Standard oral hygiene instructions; Procedure: Scaling and root planing (SRP |
| Non-surgical treatment, Control group (NST-2) | Active comparator | Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use. Receives: Procedure: Standard oral hygiene instructions; Procedure: Scaling and root planing (SRP |
| Surgical treatment, Study group (ST-1) | Experimental | Lumoral Treatment; Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use. Receives: Device: Lumoral Treatment; Procedure: Standard oral hygiene instructions; Procedure: surgical anti-infective peri-implantitis treatment |
| Surgical treatment, Control group (ST-2) | Active comparator | Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use. Receives: Procedure: Standard oral hygiene instructions; Procedure: surgical anti-infective peri-implantitis treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing (BOP)
Change in the inflammatory parameter BOP. A full-mouth assessment at six sites per tooth:
- 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 reported as the percentage (%) of sites with positive findings
- Calculation formula: number of bleeding sites/ 6 times number of teeth
Measured: 6 months
Secondary outcomes (13)
Active matrix metalloproteinase 8 (aMMP-8)
The oral rinse fluid sample collection and the aMMP-8 marker analysis will be performed using Periosafe test (Dentognostics GmbH) according to the manufacturer's instructions.
Measured: 6 months
Inflammatory marker total MMP-8 analysis
Measurement of pro and active MMP-8. Units: ng/ml.
Measured: 6 months
Inflammatory marker total MMP-9 analysis
Measurement of pro and active MMP-9. Units: ng/ml.
Measured: 6 months
Inflammatory marker total MMP-2 analysis
Measurement of pro and active MMP-2. Units: ng/ml.
Measured: 6 months
Inflammatory marker total TIMP analysis
Units: ng/ml.
Measured: 6 months
Interleukins analysis
Units: pg/ml.
Measured: 6 months
Total calprotectin analysis
Salivary calprotectin. Units: microgram/ml.
Measured: 6 months
Peridontal Pocket Depth (PPD)
A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm)
Measured: 6 months
Visual Plaque Index( VPI)
Assessment of six index teeth, measured at four sites per tooth
- Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent"
- VPI reported as the percentage (%) of sites with plaque
- Calculation formula: number of sites with plaque/ 4 times number of teeth
Measured: 6 months
Clinical Attachment Level (CAL)
A full-mouth assessment, measured at six sites per tooth
- Assessed as the distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket (mm)
The measurements to calculate CAL:
- distance from the gingival margin to the CEJ and PPD
- in recession: PPD + gingival margin to the CEJ
- in tissue overgrowth: PPD - gingival margin to the CEJ
Measured: 6 months
Bacterial flora
Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis
- Microbiological samples can be collected using Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points can be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis
Measured: 6 Months
Adverse events
Any suspicion of an adverse event related to the investigational device, the treatment method, or the study protocol.
Measured: 6 months
OHIP-14 questionnaire
- Measures people's perception of the social impact of oral disorders on their well-being.
Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. (Slade GD 1997). Responses are made on a 5-point scale (from 0 = never, to 4 = very often).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start13 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 Peri-ImplantitisStudies 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
- 80 subjects in total are recruited to this study: 40 subjects in the non-surgical treatment (NST), of which 20 participants in the NST Study group (NST-1) and 20 participants in the NST Control group (NST-2), and 40 subjects in the surgical treatment (ST), of which 20 participants in the ST Study group (ST-1) and 20 participants in the ST Control group (ST-2).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koite Health Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, Södertandläkarna
- Responsible party
- Sponsor
- Investigators
- Nilminie Rathnayake, Assoc Prof, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017817
- Sponsor's protocol ID
- HEALTHIER
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2023
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berglundh T, Jepsen S, Stadlinger B, Terheyden H. Peri-implantitis and its prevention. Clin Oral Implants Res. 2019 Feb;30(2):150-155. doi: 10.1111/clr.13401. Epub 2019 Feb 3.
PubMed 30636066Jepsen S, Berglundh T, Genco R, Aass AM, Demirel K, Derks J, Figuero E, Giovannoli JL, Goldstein M, Lambert F, Ortiz-Vigon A, Polyzois I, Salvi GE, Schwarz F, Serino G, Tomasi C, Zitzmann NU. Primary prevention of peri-implantitis: managing peri-implant mucositis. J Clin Periodontol. 2015 Apr;42 Suppl 16:S152-7. doi: 10.1111/jcpe.12369.
PubMed 25626479Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.
PubMed 25261053Kassebaum NJ, Smith AGC, Bernabe E, Fleming TD, Reynolds AE, Vos T, Murray CJL, Marcenes W; GBD 2015 Oral Health Collaborators. Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors. J Dent Res. 2017 Apr;96(4):380-387. doi: 10.1177/0022034517693566.
PubMed 28792274Lang NP, Suvan JE, Tonetti MS. Risk factor assessment tools for the prevention of periodontitis progression a systematic review. J Clin Periodontol. 2015 Apr;42 Suppl 16:S59-70. doi: 10.1111/jcpe.12350.
PubMed 25496279Lahteenmaki H, Patila T, Raisanen IT, Kankuri E, Tervahartiala T, Sorsa T. Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study. Curr Issues Mol Biol. 2022 Mar 8;44(3):1273-1283. doi: 10.3390/cimb44030085.
PubMed 35723308Nikinmaa 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 34063662Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
PubMed 9332805
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regular Home-use of Antibacterial Photodynamic Therapy in the Management of Peri-implantitis
- ClinicalTrials.gov ID
- NCT06017817
- Acronym / sponsor ID
- HEALTHIER
- Conditions
- Peri-Implantitis, Plaque, Dental
- Keywords
- Lumoral, Lumorinse, Antibacterial photodynamic therapy (aBPT), aMMP-8, Plaque control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Koite Health OyIndustry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, Södertandläkarna
- Study start
- 13 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Aug 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.
This early-stage study is designed to determine the efficacy of the Lumoral method in periimplantitis. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues, thus impacting osseointegration.
Detailed description
Clinical signs of inflammation in peri-implantitis include bleeding on probing, suppuration, increased probing depth, and radiographic signs of bone loss. Currently, the best treatment options for peri-implantitis include non-surgical methods of biofilm removal in the supra-mucosal area around implants, and comprehensive guidance on self-performed infection control procedures. With more advanced peri-implantitis, anti-infective surgical treatment protocol would be needed.
Matrix metalloproteinase 8 (MMP-8) has been found to be elevated in association with oral infections, such as periodontitis and peri-implantitis. The level of active MMP-8 (aMMP-8) can detect to determine tissue health and to assess inflammation, and can easily be measured during a regular dental appointment with a chairside test.
The Lumoral Treatment is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The method mechanism of action is antibacterial photodynamic therapy (aPDT). The method is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 80 subjects in total are recruited to this study: 40 subjects in the non-surgical treatment (NST), of which 20 participants in the NST Study group (NST-1) and 20 participants in the NST Control group (NST-2), and 40 subjects in the surgical treatment (ST), of which 20 participants in the ST Study group (ST-1) and 20 participants in the ST Control group (ST-2).
| Arm | Type | Receives |
|---|---|---|
| Non-surgical treatment, Study group (NST-1) | Experimental | Device: Lumoral Treatment, Procedure: Standard oral hygiene instructions, Procedure: Scaling and root planing (SRPLumoral Treatment; Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use. |
| Non-surgical treatment, Control group (NST-2) | Active comparator | Procedure: Standard oral hygiene instructions, Procedure: Scaling and root planing (SRPStandard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use. |
| Surgical treatment, Study group (ST-1) | Experimental | Device: Lumoral Treatment, Procedure: Standard oral hygiene instructions, Procedure: surgical anti-infective peri-implantitis treatmentLumoral Treatment; Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use. |
| Surgical treatment, Control group (ST-2) | Active comparator | Procedure: Standard oral hygiene instructions, Procedure: surgical anti-infective peri-implantitis treatmentSurgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PPD ≥6 mm and marginal bone loss >3 mm
- Dental implants collected and clinically characterized according to Lähteenmäki et al. CEDR-22
- Agreement to participate in the study and to sign a written consent form
- Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol
Key exclusion criteria (9 listed)
- Presence of any physical limitation or restriction that might restrict Lumoral use
- Unwilling to participate in the study
- Pregnancy or lactation
- Active smoking
- Medicated diabetes mellitus (DM)
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 TreatmentAnti-infective photodynamic therapy for plaque-induced oral conditions | Device | Non-surgical treatment, Study group (NST-1), Surgical treatment, Study group (ST-1) |
| Standard oral hygiene instructionsStandard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use | Procedure or surgery | Non-surgical treatment, Control group (NST-2), Non-surgical treatment, Study group (NST-1), Surgical treatment, Control group (ST-2), Surgical treatment, Study group (ST-1) |
| Scaling and root planing (SRPnon-surgical anti-infective treatment by scaling and root planing | Procedure or surgery | Non-surgical treatment, Control group (NST-2), Non-surgical treatment, Study group (NST-1) |
| surgical anti-infective peri-implantitis treatmentsurgical anti-infective peri-implantitis treatment | Procedure or surgery | Surgical treatment, Control group (ST-2), Surgical treatment, Study group (ST-1) |
Primary outcome
Bleeding on probing (BOP)
Time frame: 6 months
Change in the inflammatory parameter BOP. A full-mouth assessment at six sites per tooth: * 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 reported as the percentage (%) of sites with positive findings * Calculation formula: number of bleeding sites/ 6 times number of teeth
13 secondary outcomes
Active matrix metalloproteinase 8 (aMMP-8)
Time frame: 6 months
Inflammatory marker total MMP-8 analysis
Time frame: 6 months
Inflammatory marker total MMP-9 analysis
Time frame: 6 months
Inflammatory marker total MMP-2 analysis
Time frame: 6 months
Inflammatory marker total TIMP analysis
Time frame: 6 months
Interleukins analysis
Time frame: 6 months
Total calprotectin analysis
Time frame: 6 months
Peridontal Pocket Depth (PPD)
Time frame: 6 months
Visual Plaque Index( VPI)
Time frame: 6 months
Clinical Attachment Level (CAL)
Time frame: 6 months
Bacterial flora
Time frame: 6 Months
Adverse events
Time frame: 6 months
OHIP-14 questionnaire
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 30636066Berglundh T, Jepsen S, Stadlinger B, Terheyden H. Peri-implantitis and its prevention. Clin Oral Implants Res. 2019 Feb;30(2):150-155. doi: 10.1111/clr.13401. Epub 2019 Feb 3.
- Background: PubMed 25626479Jepsen S, Berglundh T, Genco R, Aass AM, Demirel K, Derks J, Figuero E, Giovannoli JL, Goldstein M, Lambert F, Ortiz-Vigon A, Polyzois I, Salvi GE, Schwarz F, Serino G, Tomasi C, Zitzmann NU. Primary prevention of peri-implantitis: managing peri-implant mucositis. J Clin Periodontol. 2015 Apr;42 Suppl 16:S152-7. doi: 10.1111/jcpe.12369.
- Background: PubMed 25261053Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.
- Background: PubMed 28792274Kassebaum NJ, Smith AGC, Bernabe E, Fleming TD, Reynolds AE, Vos T, Murray CJL, Marcenes W; GBD 2015 Oral Health Collaborators. Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors. J Dent Res. 2017 Apr;96(4):380-387. doi: 10.1177/0022034517693566.
- Background: PubMed 25496279Lang NP, Suvan JE, Tonetti MS. Risk factor assessment tools for the prevention of periodontitis progression a systematic review. J Clin Periodontol. 2015 Apr;42 Suppl 16:S59-70. doi: 10.1111/jcpe.12350.
- Background: PubMed 35723308Lahteenmaki H, Patila T, Raisanen IT, Kankuri E, Tervahartiala T, Sorsa T. Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study. Curr Issues Mol Biol. 2022 Mar 8;44(3):1273-1283. doi: 10.3390/cimb44030085.
- 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 9332805Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
- Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review. Laser Dent Sci 3, 147-153 (2019)Link provided by the sponsor.
- Gomes SC, Romagna R, Rossi V, Corvello PC, Melchiors-Angst PD. Supragingival treatment as an aid to reduce subgingival needs: a 450-day investigation Braz. oral res. 28 (1) 2014Link provided by the sponsor.
- Levine JI. Medications that increase photosensitivity. FDA document Dec 1990.Link provided by the sponsor.
- Nikinmaa S, Alapulli H, Auvinen P, et al. (2020) Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation. PLoS ONE 15(5)Link provided by the sponsor.
- Pereira PAB, Aho VTE, Paulin L, et al., (2017) Oral and nasal microbiota in Parkinson's disease. Parkinsonism and Related Disorders 38: 61-67Link 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.
Nilminie Rathnayake, Assoc Prof 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, Standard oral hygiene instructions and Scaling and root planing (SRP in people with Peri-Implantitis and Plaque, Dental, run by Koite Health Oy at 1 site in Sweden.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 7 Aug 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikko Kylmänen (+358407245934, mikko.kylmanen@koitehealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on probing (BOP) (time frame: 6 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 NCT06017817, 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 7 Aug 2026.