Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases (LumoPrevent)

April 15, 2024 updated by: Wellbeing Services County of Pirkanmaa

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Wellbeing Services of County Pirkanmaa
        • Principal Investigator:
          • Anna Maria Heikkinen, Professor
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Standard, personalized oral hygiene and Lumoral Treatment home-use
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.
Active Comparator: Control group
Standard, personalized oral hygiene
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on probing (BOP)
Time Frame: 12 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.
12 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active matrix metalloproteinase 8 (aMMP-8)
Time Frame: 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.
12 months
Probing Pocket Depth (PPD)
Time Frame: 6 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)
6 months
Probing Pocket Depth (PPD)
Time Frame: 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)
12 months
Visible plaque index (VPI)
Time Frame: 6 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.
6 months
Visible plaque index (VPI)
Time Frame: 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.
12 months
Decayed tooth assessment (DT)
Time Frame: 12 months

Change in the number of decayed teeth.

A full-mouth examination, the number of untreated decayed permanent teeth will be calculated.
12 months
Clinical attachment level (CAL)
Time Frame: 6 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.
6 months
Clinical attachment level (CAL)
Time Frame: 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.
12 months
Microbiological evaluation/16S rRNA analysis
Time Frame: 6 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 analysis
6 months
Microbiological evaluation/16S rRNA analysis
Time Frame: 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 analysis
12 months
Oral-related quality of life measurement (OHIP-14)
Time Frame: 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).
12 months
Absence of adverse effects
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wellbeing Services County of Pirkanmaa

Collaborators

University of Helsinki
Tampere University
Metropolia University of Applied Sciences

Investigators

  • Principal Investigator: Anna Maria Heikkinen, Professor, Wellbeing Services of County Pirkanmaa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 18, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R23060L

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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