About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Lumoral Treatment
Device
Home-use photodynamic antibacterial dual-light oral health care device with a marker substance
Standard, personalized oral health care
Other intervention
Home-based oral health care instructed by a professional, with emphasis on personal needs according to oral condition and previous oral health care habits.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Study groupExperimental treatment 2 interventions

Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Bleeding on probing (BOP)

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.

Time frame

12 months

2

Bleeding on probing (BOP)

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.

Time frame

6 months

Secondary outcomes

1

Active matrix metalloproteinase 8 (aMMP-8)

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.

Time frame

12 months

2

Probing Pocket Depth (PPD)

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)

Time frame

6 months

3

Probing Pocket Depth (PPD)

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)

Time frame

12 months

4

Visible plaque index (VPI)

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.

Time frame

6 months

Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts