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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
| Lithuanian University of Health Sciences | OTHER |
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This study is designed to determine the efficacy of the Lumoral method in chronic periodontitis with a targeted group of stage III and IV periodontitis.
Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term.
In addition, the method might have a photobiomodulation effect on periodontal tissues.
The Lumoral Treatment 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 (aPDT). The device is used by swishing a specially designed mouth rinse that strongly adheres to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator. Preliminary results have shown promising anti-inflammatory responses in addition to plaque reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. The study group shall receive the Lumoral treatment -device, Lumorinse -tablets and instructions for their use. All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss. |
|
| Control group | No Intervention | A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. All subjects shall receive standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumoral Treatment | Device | The Lumoral treatment -device is a CE-marked antibacterial home-use device for the treatment and prevention of oral diseases caused by bacteria. It is used in combination with a CE-marked mouth rinse called Lumorinse. |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on probing (BOP) | Improvement in bleeding on probing (BOP)
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Active matrix metalloproteinase 8 (aMMP-8) | Change in periodontal inflammation marker aMMP-8 | 6 months |
| Visible plaque index (VPI) | Change in visible plaque index (VPI) |
| Measure | Description | Time Frame |
|---|---|---|
| Device-related adverse event | Absence of device-related serious adverse events or any patterns of device-related adverse events graded as moderate | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timo Sorsa, Professor | University of Helsinki | Study Director |
| Tommi Pätilä, Docent | Koite Health | Study Chair |
| Ingrida Marija Pacauskiene, Doctor | Lithuanian University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Department of Dental and Oral Pathology | Kaunas | 50161 | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25261053 | Background | Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26. | |
| 28792274 | Background | Kassebaum NJ, Smith AGC, Bernabe E, Fleming TD, Reynolds AE, Vos T, Murray CJL, Marcenes W; GBD 2015 Oral Health Collaborators. Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors. J Dent Res. 2017 Apr;96(4):380-387. doi: 10.1177/0022034517693566. |
| Label | URL |
|---|---|
| Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review. Laser Dent Sci 3, 147-153 (2019) | View source |
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The IPD will only be administered by the researchers that are listed in the CIP.
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
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All clinical assessments at baseline and at 6 months shall be performed by one calibrated examiner who is blinded for the subjects' allocation to the study and control groups.
| 6 months |
| Probing pocket depth (PPD) | Change in probing pocket depth (PPD) | 6 months |
| Clinical attachment level (CAL) | Change in clinical attachment level (CAL) | 6 months |
| Deep periodontal pockets (over 4 mm) | Change in the number of deep periodontal periodontal pockets (over 4 mm) | 6 months |
| Periodontal microbiological flora | Change in periodontal microbiological flora during the study period | 6 months |
| Additional visits | Number of additional visits due to periodontitis status between 2nd and 3rd follow-up visits | 6 months |
| OHIP-14 | Patient related objectives: Oral-related quality of life measurement (OHIP-14) questionnaire | 6 months |
| 25496279 | Background | Lang NP, Suvan JE, Tonetti MS. Risk factor assessment tools for the prevention of periodontitis progression a systematic review. J Clin Periodontol. 2015 Apr;42 Suppl 16:S59-70. doi: 10.1111/jcpe.12350. |
| 34063662 | Background | Nikinmaa S, Moilanen N, Sorsa T, Rantala J, Alapulli H, Kotiranta A, Auvinen P, Kankuri E, Meurman JH, Patila T. Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque. Dent J (Basel). 2021 May 3;9(5):52. doi: 10.3390/dj9050052. |
| 9332805 | Background | Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x. |
| Gomes SC, Romagna R, Rossi V, Corvello PC, Melchiors-Angst PD. Supragingival treatment as an aid to reduce subgingival needs: a 450-day investigation Braz. oral res. 28 (1) 2014 | View source |
| Levine JI. Medications that increase photosensititivity. FDA document Dec 1990. | View source |
| Nikinmaa S, Alapulli H, Auvinen P, et al. (2020) Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation. PLoS ONE 15(5): e0232775 | View source |
| Pereira PAB, Aho VTE, Paulin L, et al., (2017) Oral and nasal microbiota in Parkinson's disease. Parkinsonism and Related Disorders 38: 61-67 | View source |
| D013568 | Pathological Conditions, Signs and Symptoms |