Clinical trial NCT06286501: Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Caries in Children
Dental Plaque
Tooth Decay
Periodontitis
Keywords: Antibacterial
Preventive oral care
Lumoral
Lead sponsor: Wellbeing Services County of Pirkanmaa
Sponsor class: OTHER
Collaborators: name: Tampere University
name: University of Helsinki
name: Metropolia University of Applied Sciences
First posted: 2024-02-29
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical study on a CE-approved medical device
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bleeding on probing (BOP)
timeFrame: 12 months
measure: Bleeding on probing (BOP)
timeFrame: 6 months
Secondary outcomes:
measure: Active matrix metalloproteinase 8 (aMMP-8)
timeFrame: 12 months
measure: Probing Pocket Depth (PPD)
timeFrame: 6 months
measure: Probing Pocket Depth (PPD)
timeFrame: 12 months
measure: Visible plaque index (VPI)
timeFrame: 6 months
measure: Visible plaque index (VPI)
timeFrame: 12 months
measure: Decayed tooth assessment (DT)
timeFrame: 12 months
measure: Clinical attachment level (CAL)
timeFrame: 6 months
measure: Clinical attachment level (CAL)
timeFrame: 12 months
measure: Microbiological evaluation/16S rRNA analysis
timeFrame: 6 months
measure: Microbiological evaluation/16S rRNA analysis
timeFrame: 12 months
measure: Oral-related quality of life measurement (OHIP-14)
timeFrame: 12 months
measure: Absence of adverse effects
timeFrame: 12 months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Wellbeing Services of County Pirkanmaa
state: Pirkanmaa
Study officials:
affiliation: Wellbeing Services of County Pirkanmaa
name: Anna Maria Heikkinen, Professor
role: PRINCIPAL_INVESTIGATOR
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