Periodontitis, Plaque, Dental, Plaque Induced Gingivitis
Conditions
Keywords
Lumoral, Lumorinse, Plaque, Periodontitis, Plaque control
Brief summary
This early-stage study is designed to determine the efficacy of the CE-approved, antibacterial, dual-light Lumoral method in 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.
Detailed description
Dental plaque triggers changes in gingival health, which results in slight swelling and bleeding from the gingival margin and causes gingivitis. Supragingival dental biofilm control can be achieved by mechanical and chemical means. Toothbrushing is effective in reducing levels of dental plaque (van der Weijden & Slot 2015). It removes plaque from flat, accessible surfaces but is less effective at the gingival margins and in approximal areas, where the accumulation of residual plaque encourages gingivitis and deterioration of periodontal health. Effective toothbrushing is also depending on a number of factors, e.g., age, knowledge, manual dexterity and motivation. Oral hygiene instructions and patient motivation in oral hygiene practices should be an integral part of the patient management during all stages of periodontal treatment (Tonetti et al., 2015). Oral health practice of individuals affects their gingival and periodontal health. 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. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction. This early-stage study is designed to determine the efficacy of the Lumoral method in 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. Forty (40) patients are randomized to the Lumoral treatment group or the control group. Both groups shall receive standard oral hygiene instructions for sonic toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontal status including visible plaque index (VPI), bleeding on probing (BOP) and probing pocket depth (PPD). In addition, aMMP-8 mouth rinse test and microbiological analysis of gingival pockets will be performed. Digital photographs after staining will be taken. These analyses shall be performed at baseline and at 4 weeks after the treatment.
Interventions
DEVICELumoral 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.
Sponsors
Tampere University
University of Helsinki
Koite Health Oy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The subjects will be randomized into the study group and the control group by using a sealed envelope system.
Intervention model description
20 participants in the treatment (Lumoral) group and 20 participants in the control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* At least 18 years old * Agreement to participate in the study and to sign a written consent form
Exclusion criteria
* Presence of any physical limitation or restriction that might restrict Lumoral use * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BoP | 4 weeks | Reduction in bleeding on probing (BoP). Procedure for BoP: * A full-mouth assessment at six sites per tooth * 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 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 |
|---|---|---|
| Microbiological pathogens | 4 weeks | Change in periodontal microbiological pathogens. The plaque sample will be taken from the teeth with ≥3 mm pockets with a sterile paper point. If the subject does not have any deep periodontal pockets, then a sample will be taken from shallow sites. Prior to sampling, the supragingival plaque will be removed with a curette. The paper point will be then taken to the gingival pocket with sterile tweezers. The paper pin will be allowed to stand for 10 to 20 seconds, after which it will be removed and sealed in an empty plastic sample transport tube. A gene amplification method (polymerase chain reaction, PCR) will be used to look for six key bacteria in periodontitis: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia and Parvimonas micra. |
| aMMP-8 | 4 weeks | Reduction in periodontal inflammation marker aMMP-8. An aMMP-8 marker analysis will be performed using Periosafe test (Dentognostics GmbH) according to the manufacturer's instructions. |
| VPI | 4 weeks | Clinical improvement concerning visible plaque index (VPI). Procedure for VPI: * A full-mouth assessment, measured at 4 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 |
| PPD | 4 weeks | Reduction in probing pocket depth (PPD). Procedure for PPD: * A full-mouth assessment, measured at six sites per tooth * Assessed from the base of the pocket to the gingival margin (mm). |
Countries
Finland
Outcome results
None listed