Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases

Periodontitis Clinical Trial

— LumoPrevent  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286501
• Other study ID #: R23060L
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Wellbeing Services County of Pirkanmaa
• Contact: Milla Sarja, Dentist
• Phone: +358405337979
• Email: milla.sarja[@]pirha.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Device:
• Lumoral Treatment
Home-use photodynamic antibacterial dual-light oral health care device with a marker substance

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

Locations

Country	Name	City	State
Finland	Wellbeing Services of County Pirkanmaa	Tampere	Pirkanmaa

Sponsors (4)

Lead Sponsor	Collaborator
Wellbeing Services County of Pirkanmaa	Metropolia University of Applied Sciences, Tampere University, University of Helsinki

Country where clinical trial is conducted

Finland, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	12 months
Secondary	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)	6 months
Secondary	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)	12 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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	6 months
Secondary	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	12 months
Secondary	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).	12 months
Secondary	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.	12 months

External Links

•   Aromaa, A, Koskinen S. Health and functional capacity in Finland : Baseline results of the Health 2000 health examination survey. National Public Health Institute. 2004.
•   Heikkinen, AM. Oral health, smoking and adolescence. Doctoral dissertation. University of Helsinki, Faculty of Medicine. Nov 2011.
•   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.