Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Lumoral Treatment
  Home-use photodynamic antibacterial dual-light oral health care device with a marker substance
• Другое 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.

Первичные конечные точки

• Bleeding on probing (BOP) [Срок оценки: 12 months]
• Bleeding on probing (BOP) [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Active matrix metalloproteinase 8 (aMMP-8) [Срок оценки: 12 months]
• Probing Pocket Depth (PPD) [Срок оценки: 6 months]
• Probing Pocket Depth (PPD) [Срок оценки: 12 months]
• Visible plaque index (VPI) [Срок оценки: 6 months]
• Visible plaque index (VPI) [Срок оценки: 12 months]
• Decayed tooth assessment (DT) [Срок оценки: 12 months]
• Clinical attachment level (CAL) [Срок оценки: 6 months]
• Clinical attachment level (CAL) [Срок оценки: 12 months]
• Microbiological evaluation/16S rRNA analysis [Срок оценки: 6 months]
• Microbiological evaluation/16S rRNA analysis [Срок оценки: 12 months]
• Oral-related quality of life measurement (OHIP-14) [Срок оценки: 12 months]
• Absence of adverse effects [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Финляндия · 1 центр

• Wellbeing Services of County Pirkanmaa — Tampere

Публикации

• 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 PMID 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. PMID 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 worksho PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 34063662

Идентификаторы

NCT: NCT06286501 · R23060L

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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