NCT03958461

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2022

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

2.9 years

First QC Date

May 15, 2019

Last Update Submit

January 27, 2023

Conditions

Keywords

periodontitisexudative age-related macular degenerationwet age-related macular degenerationAMDBABaqueous flare

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

OTHER

Anti-infective treatment of teeth

Procedure: Anti-infective treatment of periodontal pockets

Interventions

Removing calculi from teeths' periodontal pockets

Calculus removement

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 28383406BACKGROUND
  • Wagley 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: 25627087BACKGROUND
  • Karesvuo 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

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Raimo Tuuminen, PhD

    Helsinki Retina Research Group

    STUDY CHAIR
  • Minna Karesvuo, DDS

    University of Helsinki

    STUDY DIRECTOR

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

Locations