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Connection Between Periodontitis and Exudative Age-related Macular Degeneration (FLAREPARO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03958461
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : September 1, 2020
Information provided by (Responsible Party):
Petteri Karesvuo, University of Helsinki

Brief 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.

Condition or disease Intervention/treatment Phase
Periodontitis Procedure: Anti-infective treatment of periodontal pockets Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Connection Between Periodontitis and Exudative Age-related Macular Degeneration
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Calculus removement
Anti-infective treatment of teeth
Procedure: Anti-infective treatment of periodontal pockets
Removing calculi from teeths' periodontal pockets

Primary Outcome Measures :
  1. <10pu/msec to over 300pu/msec [ Time Frame: Change from Baseline aqueous flare value at 6 weeks ]
    Aqueous flare value before (in the same day) and after 6 weeks of anti-infective treatment of teeth

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • periodontitis

Exclusion Criteria:

  • no periodontitis, any eye disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03958461

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Contact: Petteri Karesvuo, M.D. +358 9 4711
Contact: Raimo Tuuminen, PhD

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Kymeenlaakson keskussairaala Recruiting
Kotka, Finland
Contact: Sam Häyry    +358 (0)5 220 51      
Sponsors and Collaborators
University of Helsinki
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Study Chair: Raimo Tuuminen, PhD Helsinki Retina Research Group
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Responsible Party: Petteri Karesvuo, Principal Investigator, M.D. FEBO, Specialist in Ophthalmology, University of Helsinki Identifier: NCT03958461    
Other Study ID Numbers: HRRG FLAREPARO
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Petteri Karesvuo, University of Helsinki:
exudative age-related macular degeneration
wet age-related macular degeneration
aqueous flare
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents