Connection Between Periodontitis and Exudative Age-related Macular Degeneration
Condition: Periodontitis
MeSH terms: Periodontitis; Macular Degeneration; Wet Macular Degeneration
Study type: Interventional

Summary: 
      Aqueous flare is increased in different kind of inflammations of eye. This is caused by
      disruption of blood-aqueous-barrier. The investigators assume that low grade systemic
      inflammation, such as periodontitis, increase aqueous flare and possibly activates exudative
      age-related macular degeneration.
    

Detailed description: 
      Periodontitis is a chronic low-grade bacterial infection of supporting tissue of teeth.
      Chronic periodontitis is often non symptomatic. Inflammation is located usually in deepened
      periodontal pockets (> 4mm or >6mm) and it leads to alveolar bone loss and eventually
      detachment of teeth. In Finland, it is estimated that 64% of people have mild form of
      periodontitis and severe form approximately 21% according to Health 2000 and Health 2011
      studies. Various gram negative and positive pathogens have been isolated in infected area,
      Porhyromonas Gingivalis, Prevotella intermedia, Treponema denticola, Tannerella forsynthesis,
      Campylobacter rectus, Aggregatibacter actinomycetemcomitans and Peptostreoptococcus micros.
      Periodontitis causes endotoxemia in circulation via inflamed supporting structure of teeth.
      Endotoxins such as lipopolysaccharide (LPS) and their concentrations are elevated in blood
      and it is found that C-reactive protein (CRP), interleukins and cytokines are also elevated
      in blood due to periodontitis. As a result periodontitis activates low-grade systemic
      inflammation and complement system activation classical and alternative pathway. In some
      studies, the treatment of periodontitis diminished CRP values and lowered the systemic
      inflammation. Periodontitis has been connected with many diseases, such as atherosclerosis,
      coronary artery disease, Alzheimer's disease and adverse pregnancy outcomes. Furthermore,
      various studies have found association between periodontitis and age-related macular
      degeneration. Severity of diabetic retinopathy was linked with severity of periodontitis
      furthermore scleritis was resoluted after periodontal treatment Aqueous flare is a hallmark
      of blood-aqueous-barrier. Increased aqueous flare is found in different types of
      inflammations and infections of eye for example in iritis and in endophthalmitis. In addition
      intraocular surgery promotes almost always aqueous flare postoperatively. Increased aqueous
      flare and macular thickening and postoperative cystoid macular edema (PCME) are found after
      uneventful cataract operation. The higher flare levels correlated with the activity in wet
      age-related macular degeneration and in addition in central retinal vein occlusion.

      Here in this study the investigators aimed to characterize the association between the
      periodontitis and elevated aqueous flare values as a potential risk factor for developing
      exudative macular degeneration.

      Material and methods Study will be conducted at Kymenlaakso Central Hospital in Kotka,
      Finland. Time period is going to be between 1.6.2019-1.6.2021. One hundred participents will
      be enrolled in this study calculated with power analysis (0.8). Drop-out patients will be
      about 5%. The investigators will measure periodontal pockets (>4mm or >6mm) and number of
      affected teeth and give anti-infective treatment in addition to taking bacterial PCR samples.
      Follow up visits will be after 6 weeks.

      Non-invasive and safe aqueous flare measurements will be performed by investigators with
      aqueous flare meter (FM-600 Kowa Company, Ltd., Nagoya, Japan) before and 1 hour after
      anti-infective treatment. The flare values varies between < 10 photon units pu/msec in
      healthy subjects without BAB disruption and over 300 pu/msec in eyes with severe BAB
      disruption. Automated reliability analysis of the measurements performed by the laser flare
      meter will be taken into account. The patient information will be stored in a password
      protected computer and no one else outside the study is not allowed to participate the study
      and process the data. Study material will be processed in a HUS computer or in a password
      protected personal computer via VPN communication link. Helsinki University Helpdesk will
      offer user interface. Participents personal infromation will be deleted after usage and
      anonymous registry and data will be stored for 5 years in a digital password protected SSD
      memory after the publication of the study findings.

      Ethical perspectives The treatment models used in the study comply with Good Clinical
      Practice. The patient will be provided with both verbal and written information before
      signing the consent form. Study subjects may withdraw their consent after the study has
      begun. The study will have no effect in any way on the care that the patient receives.
      Information about the study subject and the results obtained from the study will be handled
      confidentially. The study aims to provide the latest definitive results, nor can it be
      conducted in any other way. The study may have a significant benefit on understanding wet AMD
      pathophysiology. The study will follow the principles of the Declaration of Helsinki of the
      World Medical Association.
    

Intervention name(s): Anti-infective treatment of periodontal pockets
Intervention type(s): Procedure
Intervention description(s): Removing calculi from teeths' periodontal pockets
Intervention MeSH terms: Anti-Infective Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: periodontitis; exudative age-related macular degeneration; wet age-related macular degeneration; AMD; BAB; aqueous flare