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Dental Caries in ChildrenLumoPreventNCT06286501

Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases

A study testing Lumoral Treatment and Standard, personalized oral health care in people with Dental Caries in Children and Dental Plaque, run by Wellbeing Services County of Pirkanmaa at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to identify adolescent patients that are at risk of developing oral diseases, and to assess if targeted preventive oral treatment with antibacterial dual-light therapy as an adjunctive treatment method can have a positive impact in preventing oral diseases from emerging. Read more about this study

Who is it for?
Ages 14 to 16 yearsHealthy volunteers can take part
What is being tested?
Lumoral Treatment and Standard, personalized oral health care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
1 siteFinland
Study dates
18 Apr 2024to 9 Jun 2026
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 14 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 14-16 years old, and a junior high school 8th-grade pupil from the area of the Wellbeing Services of County Pirkanmaa
  • Agreement to participate in the study and to sign a written consent form, including either consent from caregiver(s) with pupils under 14 years, or information to caregiver(s) with pupils from 15 to 16 years old
  • Able to cooperate with the treatment

Who cannot join

  • Presence of any physical limitation or restriction that might restrict Lumoral use
  • Unwilling to participate in the study
  • Periodontal treatment within 3 months prior to study

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Wellbeing Services of County Pirkanmaa

    Tampere, Pirkanmaa, 33520

Other trials in Finland

About this study

Official title: Identification of Adolescent Patients at Risk of Oral Diseases and Targeting of Preventive Treatment, and the Use of Antibacterial Photodynamic Therapy as an Adjunctive Treatment Method

The aim of the study is to identify adolescent patients that are at risk of developing oral diseases, and to assess if targeted preventive oral treatment with antibacterial dual-light therapy as an adjunctive treatment method can have a positive impact in preventing oral diseases from emerging.

Read the detailed description

Good oral health is an essential factor in people's general and psychosocial well-being. According to the Global Burden of Disease 2020, untreated dental caries (tooth decay) in permanent teeth is the most common health condition. Modern dietary habits in developed countries, with increased consumption of sugar and other products that are known to have a negative impact on oral health need to be looked at both at regional and global levels. Educational programs that promote oral health awareness and emphasize the importance of good oral hygiene may be effective in encouraging adolescents to adopt healthy habits.

Globally, tooth decay is very common among children (WHO 2022), and in Finland, the oral health of children and adolescents has deteriorated in recent years. However, the risk of a young person's tooth decay can be reduced by promoting good oral hygiene by implementing less destructive dietary habits and enhanced oral health habits.

Poor dental plaque control causes increased oral bacterial burden, which is known to be associated with inflammatory oral diseases, such as periodontitis. Periodontitis is very common in Finland, for example, according to a national Health 2000 survey, the prevalence was 64 % in the adult population, and 10-15 % in adolescents. Periodontitis can lead to tooth loss, and there is a link between periodontitis and many systemic diseases as untreated periodontitis may maintain low-grade inflammation in the body.

Recent studies have identified effective methods, such as the aMMP-8 point-of-care test, for identifying oral inflammatory burden, also on adolescents. New tools in fighting a global battle against bacteria-caused tooth decay are welcome. Antibacterial photodynamic therapy (aPDT) and antibacterial blue light (aBL) have emerged as solutions for attacking dental biofilm. Until recently, these treatment methods have only been available in an office setting. A group of Finnish scientists has developed a new and unique home-use aPDT and aBL method, which has proven to have a very strong emphasis on eliminating harmful oral bacteria. The method is used along with the best-so-far home-based dental care, brushing, and flossing.

Being tested
Lumoral Treatment, Standard, personalized oral health care
Keywords
Antibacterial, Preventive oral care, Lumoral
Medical subject headings
Dental Plaque, Dental Caries, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lumoral TreatmentDevice

    Home-use photodynamic antibacterial dual-light oral health care device with a marker substance

  • Standard, personalized oral health careOther

    Home-based oral health care instructed by a professional, with emphasis on personal needs according to oral condition and previous oral health care habits.

Study groups in NCT06286501
Study groupRoleWhat they receive
Study groupExperimentalStandard, personalized oral hygiene and Lumoral Treatment home-use
Receives: Device: Lumoral Treatment; Other: Standard, personalized oral health care
Control groupActive comparatorStandard, personalized oral hygiene
Receives: Other: Standard, personalized oral health care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: 12 months

  2. 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: 6 months

Secondary outcomes (12)

  1. Active matrix metalloproteinase 8 (aMMP-8)

    Change in the accurate periodontal inflammation marker aMMP-8 level at 12 months compared to baseline.

    The aMMP-8 marker analysis will be performed using Periosafe chairside test (Dentognostics GmbH) according to the manufacturer's instructions.

    Measured: 12 months

  2. 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: 6 months

  3. 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: 12 months

  4. Visible plaque index (VPI)

    Change in 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

  5. Visible plaque index (VPI)

    Change in 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: 12 months

  6. Decayed tooth assessment (DT)

    Change in the number of decayed teeth.

    A full-mouth examination, the number of untreated decayed permanent teeth will be calculated.

    Measured: 12 months

  7. Clinical attachment level (CAL)

    Change in CAL.

    A full mouth assessment. CAL is a combination of two measurements: 1) at least 2 mm distance from the gingival margin to the cementoenamel junction (CEJ ), and 2) probing depth. The calculation (x + x) forms the CAL value.

    Measured: 6 months

  8. Clinical attachment level (CAL)

    Change in CAL.

    A full mouth assessment. CAL is a combination of two measurements: 1) at least 2 mm distance from the gingival margin to the cementoenamel junction (CEJ ), and 2) probing depth. The calculation (x + x) forms the CAL value.

    Measured: 12 months

  9. Microbiological evaluation/16S rRNA analysis

    Change in composition of bacterial flora at 12 months compared to the baseline.

    A microbial sample shall be obtained from a periodontal pocket, or from the Cementoenamel junction using a paper point. 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

  10. Microbiological evaluation/16S rRNA analysis

    Change in composition of bacterial flora at 12 months compared to the baseline.

    A microbial sample shall be obtained from a periodontal pocket, or from the Cementoenamel junction using a paper point. 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: 12 months

  11. Oral-related quality of life measurement (OHIP-14)

    OHIP-14 is a standardized questionnaire for oral-related symptoms. It 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: 12 months

  12. Absence of adverse effects

    The presence of device-related serious adverse events (SAE) or any patterns of device-related adverse events (AE) will be monitored and the number of incidents will be calculated.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2024
  2. Study start18 Apr 2024
  3. Primary completion9 Jun 2026
  4. Study completion9 Jun 2026

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized clinical study on a CE-approved medical device
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06286501
Sponsor's protocol ID
R23060L
Acronym
LumoPrevent
Status last verified
Oct 2026
First submitted
22 Feb 2024
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • GBD 2017 Oral Disorders Collaborators; Bernabe E, Marcenes W, Hernandez CR, Bailey J, Abreu LG, Alipour V, Amini S, Arabloo J, Arefi Z, Arora A, Ayanore MA, Barnighausen TW, Bijani A, Cho DY, Chu DT, Crowe CS, Demoz GT, Demsie DG, Dibaji Forooshani ZS, Du M, El Tantawi M, Fischer F, Folayan MO, Futran ND, Geramo YCD, Haj-Mirzaian A, Hariyani N, Hasanzadeh A, Hassanipour S, Hay SI, Hole MK, Hostiuc S, Ilic MD, James SL, Kalhor R, Kemmer L, Keramati M, Khader YS, Kisa S, Kisa A, Koyanagi A, Lalloo R, Le Nguyen Q, London SD, Manohar ND, Massenburg BB, Mathur MR, Meles HG, Mestrovic T, Mohammadian-Hafshejani A, Mohammadpourhodki R, Mokdad AH, Morrison SD, Nazari J, Nguyen TH, Nguyen CT, Nixon MR, Olagunju TO, Pakshir K, Pathak M, Rabiee N, Rafiei A, Ramezanzadeh K, Rios-Blancas MJ, Roro EM, Sabour S, Samy AM, Sawhney M, Schwendicke F, Shaahmadi F, Shaikh MA, Stein C, Tovani-Palone MR, Tran BX, Unnikrishnan B, Vu GT, Vukovic A, Warouw TSS, Zaidi Z, Zhang ZJ, Kassebaum NJ. Global, Regional, and National Levels and Trends in Burden of Oral Conditions from 1990 to 2017: A Systematic Analysis for the Global Burden of Disease 2017 Study. J Dent Res. 2020 Apr;99(4):362-373. doi: 10.1177/0022034520908533. Epub 2020 Mar 2.

    PubMed 32122215

  • Aytac Bal F, Ozkocak I, Cadirci BH, Sirin Karaarslan E, Cakdinleyen M, Agaccioglu M. Effects of photodynamic therapy with indocyanine green on Streptococcus mutans biofilm. Photodiagnosis Photodyn Ther. 2019 Jun;26:229-234. doi: 10.1016/j.pdpdt.2019.04.005. Epub 2019 Apr 6.

    PubMed 30965147

  • Chapple IL, Bouchard P, Cagetti MG, Campus G, Carra MC, Cocco F, Nibali L, Hujoel P, Laine ML, Lingstrom P, Manton DJ, Montero E, Pitts N, Range H, Schlueter N, Teughels W, Twetman S, Van Loveren C, Van der Weijden F, Vieira AR, Schulte AG. Interaction of lifestyle, behaviour or systemic diseases with dental caries and periodontal diseases: consensus report of group 2 of the joint EFP/ORCA workshop on the boundaries between caries and periodontal diseases. J Clin Periodontol. 2017 Mar;44 Suppl 18:S39-S51. doi: 10.1111/jcpe.12685.

    PubMed 28266114

  • Costa SA, Nascimento GG, Colins PMG, Alves CMC, Thomaz EBAF, Carvalho Souza SF, da Silva AAM, Ribeiro CCC. Investigating oral and systemic pathways between unhealthy and healthy dietary patterns to periodontitis in adolescents: A population-based study. J Clin Periodontol. 2022 Jun;49(6):580-590. doi: 10.1111/jcpe.13625. Epub 2022 Apr 19.

    PubMed 35415936

  • Dimenas SL, Jonsson B, Andersson JS, Lundgren J, Petzold M, Abrahamsson I, Abrahamsson KH. A person-centred, theory-based, behavioural intervention programme for improved oral hygiene in adolescents: A randomized clinical field study. J Clin Periodontol. 2022 Apr;49(4):378-387. doi: 10.1111/jcpe.13601. Epub 2022 Feb 23.

    PubMed 35132653

  • Heikkinen AM, Raivisto T, Raisanen I, Tervahartiala T, Bostanci N, Sorsa T. Implementing of aMMP-8 point-of-care test with a modified new disease classification in Finnish adolescent cohorts. Clin Exp Dent Res. 2022 Oct;8(5):1142-1148. doi: 10.1002/cre2.603. Epub 2022 Jun 8.

    PubMed 35676762

  • Hentila J, Laakamaa N, Sorsa T, Meurman J, Valimaa H, Nikinmaa S, Kankuri E, Tauriainen T, Patila T. Dual-Light Photodynamic Therapy Effectively Eliminates Streptococcus Oralis Biofilms. J Pharm Pharm Sci. 2021;24:484-487. doi: 10.18433/jpps32084.

    PubMed 34559627

  • Nikinmaa 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 34063662

  • Pussinen PJ, Paju S, Viikari J, Salminen A, Taittonen L, Laitinen T, Burgner D, Kahonen M, Lehtimaki T, Hutri-Kahonen N, Raitakari O, Juonala M. Childhood Oral Infections Associate with Adulthood Metabolic Syndrome: A Longitudinal Cohort Study. J Dent Res. 2020 Sep;99(10):1165-1173. doi: 10.1177/0022034520929271. Epub 2020 Jun 1.

    PubMed 32479136

  • Pakarinen S, Saarela RKT, Valimaa H, Heikkinen AM, Kankuri E, Noponen M, Alapulli H, Tervahartiala T, Raisanen IT, Sorsa T, Patila T. Home-Applied Dual-Light Photodynamic Therapy in the Treatment of Stable Chronic Periodontitis (HOPE-CP)-Three-Month Interim Results. Dent J (Basel). 2022 Nov 2;10(11):206. doi: 10.3390/dj10110206.

    PubMed 36354651

  • Raisanen IT, Sorsa T, Tervahartiala T, Raivisto T, Heikkinen AM. Low association between bleeding on probing propensity and the salivary aMMP-8 levels in adolescents with gingivitis and stage I periodontitis. J Periodontal Res. 2021 Apr;56(2):289-297. doi: 10.1111/jre.12817. Epub 2020 Dec 11.

    PubMed 33305834

Questions about this trial

What is this clinical trial studying?

A study testing Lumoral Treatment and Standard, personalized oral health care in people with Dental Caries in Children and Dental Plaque, run by Wellbeing Services County of Pirkanmaa 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 3 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 19 Oct 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 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 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?

Bleeding on probing (BOP) (time frame: 12 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?

On the ClinicalTrials.gov record for NCT06286501, which also lists 11 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 Oct 2026.

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