Periodontitis Chronic Generalized Moderate, Periodontitis Chronic Generalized Severe
Conditions
Keywords
Lumoral, Lumorinse, Periodontitis, Anti-bacterial photodynamic therapy, aPDT, Plaque, aMMP-8, Photobiomodulation
Brief summary
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.
Detailed description
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.
Interventions
DEVICELumoral Treatment
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.
Sponsors
Koite Health Oy
University of Helsinki
Lithuanian University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Periodontal disease stage III-IV, according to criteria the American Academy of Periodontology (AAP) with at least 3 mm interdental clinical attachment level (CAL) in the site of greatest loss. * ≥ 18 years old * Presence of ≥20 teeth, including implants * Agreement to participate in the study and to sign a written consent form * Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol
Exclusion criteria
* Grade A or C periodontitis * Presence of any physical limitation or restriction that might restrict Lumoral use * Pregnancy or lactation * Active smoking * Medicated diabetes mellitus (DM) * Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease * Use of antibiotics within 4 weeks week prior study * Periodontal treatment within 3 months prior study * Removable major prosthesis or major orthodontic appliance * A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on probing (BOP) | 6 months | Improvement 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
| Measure | Time frame | Description |
|---|---|---|
| Active matrix metalloproteinase 8 (aMMP-8) | 6 months | Change in periodontal inflammation marker aMMP-8 |
| Visible plaque index (VPI) | 6 months | Change in visible plaque index (VPI) |
| Probing pocket depth (PPD) | 6 months | Change in probing pocket depth (PPD) |
| Clinical attachment level (CAL) | 6 months | Change in clinical attachment level (CAL) |
| Deep periodontal pockets (over 4 mm) | 6 months | Change in the number of deep periodontal periodontal pockets (over 4 mm) |
| Periodontal microbiological flora | 6 months | Change in periodontal microbiological flora during the study period |
| Additional visits | 6 months | Number of additional visits due to periodontitis status between 2nd and 3rd follow-up visits |
| OHIP-14 | 6 months | Patient related objectives: Oral-related quality of life measurement (OHIP-14) questionnaire |
Countries
Lithuania
Contacts
STUDY_DIRECTORTimo Sorsa, Professor
University of Helsinki
STUDY_CHAIRTommi Pätilä, Docent
Koite Health
PRINCIPAL_INVESTIGATORIngrida Marija Pacauskiene, Doctor
Lithuanian University of Health Sciences
Outcome results
None listed