An interventional study of Lumoral treatment and Standard oral hygiene self care in Periodontal Diseases, Periodontitis and Plaque, Dental, sponsored by Koite Health Oy. Completed at 3 sites in Finland. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-02-18.
Sponsored by Koite Health Oy · Not applicable, Interventional, and Treatment
This early-stage research is designed to determine the efficacy of the Lumoral method in chronic periodontitis patients. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.
Periodontitis is a chronic inflammatory disease leading to a progressive loss of the tooth-supporting apparatus. The disease is strongly associated with deranged biodiversity patterns in dental plaque.
The Lumoral is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy. The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in a longterm use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.
Ninety (90) stage I-III periodontitis patients are randomized to Lumoral treatment group or control group. Both groups shall receive mechanical plaque control by scaling and root planning (SRP) and standard oral hygiene instructions for electric toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontitis status. These assessment and analyses shall be performed at baseline, at 3 months and at 6 months after the treatment.
590 studies on the registry are indexed under Gingivitis; 105 are open to participants now.
This study's enrollment of 41 is below the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Koite Health Oy is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Subjects will receive detailed instructions for the use of Lumoral treatment -device and Lumorinse -tablets. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol five to seven (5-7) times a week. Regular use shall be defined as frequency of a minimum of twice a week. Standard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects.
Device: Lumoral treatment · Other: Standard oral hygiene self care
Standard oral hygiene instructions will be provided verbally and in writing. In addition, an electric toothbrush will be provided to all subjects.
Other: Standard oral hygiene self care
The investigational Lumoral treatment -device provides a constant and repeatable application which can be done at home and is easily available. All subjects in the study group will receive their own Lumoral treatment -device and Lumorinse-mouth rinse tablets for the complete duration of the study.
Also known as: Lumorinse mouth rinse
Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self-care.
Also known as: Electric toothbrush provided
Reduction in dental inflammation
Possible changes in dental inflammation measured by bleeding on probing (BoP) when compared to control group at 3 months compared to baseline
Time frame: 3 months
Reduction in dental inflammation
Possible changes in dental inflammation measured by bleeding on probing (BoP) when compared to control group at 6 months compared to baseline
Time frame: 6 months
Stabilization of the periodontal disease
Possible changes in the periodontal disease, measured by total probing pocket depth (PPD) progression in the patient mouth at 3 months compared to baseline
Time frame: 3 months
Stabilization of the periodontal disease
Possible changes in the periodontal disease, measured by total probing pocket depth (PPD) progression in the patient mouth at 6 months compared to baseline
Time frame: 6 months
Reduction in aMMP-8 measurement
Clinical improvement in periodontal inflammation marker aMMP-8 measured by Periosafe® at 3 months compared to baseline
Time frame: 3 months
Reduction in aMMP-8 measurement
Clinical improvement in periodontal inflammation marker aMMP-8 measured by Periosafe® at 6 months compared to baseline
Time frame: 6 months
Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status
Clinical improvement of periodontitis measured by probing pocket depth (PPD) at 3 months based on the absolute values of PPD. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N.
Time frame: 3 months
Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status
Clinical improvement of periodontitis measured by probing pocket depth (PPD) at 6 months based on the absolute values of PPD. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N.
Time frame: 6 months
Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status
Clinical improvement of periodontitis measured by clinical attachment level (CAL) at 3 months based on the absolute values of CAL. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N.
Time frame: 3 months
Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status
Clinical improvement of periodontitis measured by clinical attachment level (CAL) at 6 months based on the absolute values of CAL. All clinical parameters will be recorded with the help of a graded periodontal manual probe (for example, North Carolina 54B or UNC15 probe (Hu-Friedy Mfg. Co., LLC) or similar device) with a maximum force of 0.25 N.
Time frame: 6 months
Change in periodontal microbiological pathogens.
Clinical improvement in periodontal microbiological pathogens at 3 months compared to baseline. The microbiological evaluation is the Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis. Microbiological sample will be collected using so called Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points will then be be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis.
Time frame: 3 months
Change in periodontal microbiological pathogens.
Clinical improvement in periodontal microbiological pathogens at 6 months compared to baseline. The microbiological evaluation is the Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis. Microbiological sample will be collected using so called Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points will then be be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis.
Time frame: 6 months
Improvement in oral-related quality of life.
Patient related objectives: Improvement in oral-related quality of life measurement (OHIP-14) questionnaire at baseline, at 3 months compared to baseline. Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. Grading is based on answering a five-scale questionnaire from 'Never' to 'Very often'.
Time frame: 3 months
Improvement in oral-related quality of life.
Patient related objectives: Improvement in oral-related quality of life measurement (OHIP-14) questionnaire at baseline, at 6 months compared to baseline. Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. Grading is based on answering a five-scale questionnaire from 'Never' to 'Very often'.
Time frame: 6 months
Plan to share: No
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Koite Health Oy