Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03958461
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : September 1, 2020
Sponsor:
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

Show Show detailed description

Layout table for study information
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.


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

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 ClinicalTrials.gov identifier (NCT number): NCT03958461


Contacts
Layout table for location contacts
Contact: Petteri Karesvuo, M.D. +358 9 4711 petteri.karesvuo@helsinki.fi
Contact: Raimo Tuuminen, PhD raimo.tuuminen@helsinki.fi

Locations
Layout table for location information
Finland
Kymeenlaakson keskussairaala Recruiting
Kotka, Finland
Contact: Sam Häyry    +358 (0)5 220 51      
Sponsors and Collaborators
University of Helsinki
Investigators
Layout table for investigator information
Study Chair: Raimo Tuuminen, PhD Helsinki Retina Research Group
Publications:
Layout table for additonal information
Responsible Party: Petteri Karesvuo, Principal Investigator, M.D. FEBO, Specialist in Ophthalmology, University of Helsinki
ClinicalTrials.gov 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

Layout table for additional information
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:
periodontitis
exudative age-related macular degeneration
wet age-related macular degeneration
AMD
BAB
aqueous flare
Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents