Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases
- Conditions
- Dental Caries in ChildrenDental PlaqueTooth DecayPeriodontitis
- Interventions
- Device: Lumoral TreatmentOther: Standard, personalized oral health care
- Registration Number
- NCT06286501
- Lead Sponsor
- Wellbeing Services County of Pirkanmaa
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study group Lumoral Treatment Standard, personalized oral hygiene and Lumoral Treatment home-use Control group Standard, personalized oral health care Standard, personalized oral hygiene Study group Standard, personalized oral health care Standard, personalized oral hygiene and Lumoral Treatment home-use
- Primary Outcome Measures
Name Time Method Bleeding on probing (BOP) 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 Outcome Measures
Name Time Method Active matrix metalloproteinase 8 (aMMP-8) 12 months 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.Probing Pocket Depth (PPD) 12 months 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)Visible plaque index (VPI) 12 months 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.Microbiological evaluation/16S rRNA analysis 12 months 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 analysisDecayed tooth assessment (DT) 12 months Change in the number of decayed teeth.
A full-mouth examination, the number of untreated decayed permanent teeth will be calculated.Clinical attachment level (CAL) 12 months 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.Oral-related quality of life measurement (OHIP-14) 12 months 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).Absence of adverse effects 12 months 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.
Trial Locations
- Locations (1)
Wellbeing Services of County Pirkanmaa
🇫🇮Tampere, Pirkanmaa, Finland