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.
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
- Conditions the study is for
- Dental Caries in Children, Dental Plaque, Tooth Decay
- What is being tested?
- Lumoral Treatment and Standard, personalized oral health care
- Type of treatment
- Pill or oral medicine, Medical device
- 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
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
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.
- Conditions
- Dental Caries in Children, Dental Plaque, Tooth Decay, Periodontitis
- 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 group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Standard, personalized oral hygiene and Lumoral Treatment home-use Receives: Device: Lumoral Treatment; Other: Standard, personalized oral health care |
| Control group | Active comparator | Standard, 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.
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
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)
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted29 Feb 2024
- Study start18 Apr 2024
- Primary completion9 Jun 2026
- Study completion9 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Wellbeing Services County of Pirkanmaa
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, University of Helsinki, Metropolia University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Anna Maria Heikkinen, Professor, Principal investigator, Wellbeing Services of County Pirkanmaa
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 32122215Aytac 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 30965147Chapple 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 28266114Costa 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 35415936Dimenas 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 35132653Heikkinen 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 35676762Hentila 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 34559627Nikinmaa 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 34063662Pussinen 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 32479136Pakarinen 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 36354651Raisanen 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