This early-stage study is designed to determine the efficacy of the Lumoral method in periimplantitis. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues, thus impacting osseointegration.
Clinical signs of inflammation in peri-implantitis include bleeding on probing, suppuration, increased probing depth, and radiographic signs of bone loss. Currently, the best treatment options for peri-implantitis include non-surgical methods of biofilm removal in the supra-mucosal area around implants, and comprehensive guidance on self-performed infection control procedures. With more advanced peri-implantitis, anti-infective surgical treatment protocol would be needed. Matrix metalloproteinase 8 (MMP-8) has been found to be elevated in association with oral infections, such as periodontitis and peri-implantitis. The level of active MMP-8 (aMMP-8) can detect to determine tissue health and to assess inflammation, and can easily be measured during a regular dental appointment with a chairside test. 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 method mechanism of action is antibacterial photodynamic therapy (aPDT). The method 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Anti-infective photodynamic therapy for plaque-induced oral conditions
Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use
non-surgical anti-infective treatment by scaling and root planing
Södertandläkarna AB
Stockholm, Sweden
RECRUITINGBleeding on probing (BOP)
Change in the inflammatory parameter 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
Time frame: 6 months
Active matrix metalloproteinase 8 (aMMP-8)
The oral rinse fluid sample collection and the aMMP-8 marker analysis will be performed using Periosafe test (Dentognostics GmbH) according to the manufacturer's instructions.
Time frame: 6 months
Inflammatory marker total MMP-8 analysis
Measurement of pro and active MMP-8. Units: ng/ml.
Time frame: 6 months
Inflammatory marker total MMP-9 analysis
Measurement of pro and active MMP-9. Units: ng/ml.
Time frame: 6 months
Inflammatory marker total MMP-2 analysis
Measurement of pro and active MMP-2. Units: ng/ml.
Time frame: 6 months
Inflammatory marker total TIMP analysis
Units: ng/ml.
Time frame: 6 months
Interleukins analysis
Units: pg/ml.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
surgical anti-infective peri-implantitis treatment
Total calprotectin analysis
Salivary calprotectin. Units: microgram/ml.
Time frame: 6 months
Peridontal Pocket Depth (PPD)
A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm)
Time frame: 6 months
Visual Plaque Index( 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
Clinical Attachment Level (CAL)
A full-mouth assessment, measured at six sites per tooth \- Assessed as the distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket (mm) The measurements to calculate CAL: * distance from the gingival margin to the CEJ and PPD * in recession: PPD + gingival margin to the CEJ * in tissue overgrowth: PPD - gingival margin to the CEJ
Time frame: 6 months
Bacterial flora
Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis \- Microbiological samples can be collected using Iso Taper Paper Points, size-20 (VDW GmbH) from selected gingival/periodontal pockets with maximum initial probing depth. The paper points can be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis
Time frame: 6 Months
Adverse events
Any suspicion of an adverse event related to the investigational device, the treatment method, or the study protocol.
Time frame: 6 months
OHIP-14 questionnaire
\- Measures people's perception of the social impact of oral disorders on their well-being. Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. (Slade GD 1997). Responses are made on a 5-point scale (from 0 = never, to 4 = very often).
Time frame: 6 months