Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases

NCT06286501 | Recruiting

• 1 other identifier: R23060L
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries in Children; Dental Plaque; Tooth Decay; Periodontitis

Keywords

Antibacterial; Preventive oral care; Lumoral

Outcome Measures

Primary Outcomes (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.

  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.

  6 months

Secondary Outcomes (12)

• Active matrix metalloproteinase 8 (aMMP-8)

  12 months

• Probing Pocket Depth (PPD)

  6 months

• Probing Pocket Depth (PPD)

  12 months

• Visible plaque index (VPI)

  6 months

• Visible plaque index (VPI)

  12 months

Study Arms (2)

Study group

EXPERIMENTAL

Standard, personalized oral hygiene and Lumoral Treatment home-use

Device: Lumoral Treatment; Other: Standard, personalized oral health care

Control group

ACTIVE COMPARATOR

Standard, personalized oral hygiene

Other: Standard, personalized oral health care

Interventions

Lumoral Treatment DEVICE

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

Study group

Standard, personalized oral health care OTHER

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

Control group; Study group

Eligibility Criteria

• Age: 14 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wellbeing Services County of Pirkanmaa: lead
• Tampere University: collaborator
• University of Helsinki: collaborator
• Metropolia University of Applied Sciences: collaborator

Study Sites (1)

Wellbeing Services of County Pirkanmaa

Tampere, Pirkanmaa, 33520, Finland

RECRUITING

Related Publications (11)

• 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.

  PMID: 32122215 BACKGROUND

• 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.

  PMID: 30965147 BACKGROUND

• 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.

  PMID: 28266114 BACKGROUND

• 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.

  PMID: 35415936 BACKGROUND

• 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.

  PMID: 35132653 BACKGROUND

• 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.

  PMID: 35676762 BACKGROUND

• 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.

  PMID: 34559627 BACKGROUND

• 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.

  PMID: 34063662 BACKGROUND

• 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.

  PMID: 32479136 BACKGROUND

• 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.

  PMID: 36354651 BACKGROUND

• 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.

  PMID: 33305834 BACKGROUND

Related Links

• Heikkinen, AM. Oral health, smoking and adolescence. Doctoral dissertation. University of Helsinki, Faculty of Medicine. Nov 2011.
• Aromaa, A, Koskinen S. Health and functional capacity in Finland : Baseline results of the Health 2000 health examination survey. National Public Health Institute. 2004.
• Honkala S, (ed.), Heikka H, (ed.), Heikkinen M, (ed.), Helenius-Hietala J, (ed.), Sirviö K, (ed.). Terve suu. Helsinki: Kustannusosakeyhtiö Duodecim, 2020. 464 p.
• Periodontitis ("Gum disease"). Duodecim current care guidelines. May 2018.
• Raivisto T, Sorsa T, Räisänen IT, Kauppila T, Ruokonen H, Tervahartiala T, Haukka J, Heikkinen AM.Active Matrix Metalloproteinase-8 Chair Side Mouth Rinse Test, Health Behaviour and Oral Health in Finnish Adolescent Cohort.J Clin of Diagn Res.2020.
• WHO - Oral Health. World Health Organization Newsroom, March 2023.

MeSH Terms

Conditions

Dental Plaque; Dental Caries; Periodontitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Tooth Demineralization; Periodontal Diseases; Mouth Diseases

Study Officials

• Anna Maria Heikkinen, Professor

  Wellbeing Services of County Pirkanmaa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Milla Sarja, Dentist

CONTACT

+358405337979; milla.sarja@pirha.fi

Mikko Kylmänen, Master of Health Care

CONTACT

mikko.kylmanen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data will be collected using individual study codes for participants. Study codes do not reveal which group the participant has belonged to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical study on a CE-approved medical device

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: April 18, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)