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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Caries in Children
- Sponsor
- Wellbeing Services County of Pirkanmaa
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Bleeding on probing (BOP)
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Bleeding on probing (BOP)
Time Frame: 6 months
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.
Secondary Outcomes
- Active matrix metalloproteinase 8 (aMMP-8)(12 months)
- Probing Pocket Depth (PPD)(12 months)
- Visible plaque index (VPI)(12 months)
- Microbiological evaluation/16S rRNA analysis(12 months)
- Decayed tooth assessment (DT)(12 months)
- Clinical attachment level (CAL)(12 months)
- Oral-related quality of life measurement (OHIP-14)(12 months)
- Absence of adverse effects(12 months)