Connection Between Periodontitis and Exudative Age-related Macular Degeneration
FLAREPARO
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2019
CompletedFirst Posted
Study publicly available on registry
May 22, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2022
CompletedJanuary 30, 2023
January 1, 2023
2.9 years
May 15, 2019
January 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
<10pu/msec to over 300pu/msec
Aqueous flare value before (in the same day) and after 6 weeks of anti-infective treatment of teeth
Change from Baseline aqueous flare value at 6 weeks
Study Arms (1)
Calculus removement
OTHERAnti-infective treatment of teeth
Interventions
Removing calculi from teeths' periodontal pockets
Eligibility Criteria
You may qualify if:
- periodontitis
You may not qualify if:
- no periodontitis, any eye disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kymeenlaakson keskussairaala
Kotka, Finland
Related Publications (3)
Shin YU, Lim HW, Hong EH, Kang MH, Seong M, Nam E, Cho H. The association between periodontal disease and age-related macular degeneration in the Korea National health and nutrition examination survey: A cross-sectional observational study. Medicine (Baltimore). 2017 Apr;96(14):e6418. doi: 10.1097/MD.0000000000006418.
PMID: 28383406BACKGROUNDWagley S, Marra KV, Salhi RA, Gautam S, Campo R, Veale P, Veale J, Arroyo JG. PERIODONTAL DISEASE AND AGE-RELATED MACULAR DEGENERATION: Results From the National Health and Nutrition Examination Survey III. Retina. 2015 May;35(5):982-8. doi: 10.1097/IAE.0000000000000427.
PMID: 25627087BACKGROUNDKaresvuo P, Gursoy UK, Pussinen PJ, Suominen AL, Huumonen S, Vesti E, Kononen E. Alveolar bone loss associated with age-related macular degeneration in males. J Periodontol. 2013 Jan;84(1):58-67. doi: 10.1902/jop.2012.110643. Epub 2012 Mar 13.
PMID: 22414258BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Raimo Tuuminen, PhD
Helsinki Retina Research Group
- STUDY DIRECTOR
Minna Karesvuo, DDS
University of Helsinki
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, M.D. FEBO, Specialist in Ophthalmology
Study Record Dates
First Submitted
May 15, 2019
First Posted
May 22, 2019
Study Start
January 1, 2020
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Last Updated
January 30, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share