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

January 27, 2023 updated by: Petteri Karesvuo, University of Helsinki
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kotka, Finland
        • Kymeenlaakson keskussairaala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • periodontitis

Exclusion Criteria:

  • no periodontitis, any eye disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
<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
Change from Baseline aqueous flare value at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Investigators

  • Study Chair: Raimo Tuuminen, PhD, Helsinki Retina Research Group
  • Study Director: Minna Karesvuo, DDS, University of Helsinki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 7, 2022

Study Completion (Actual)

December 7, 2022

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

May 17, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRRG FLAREPARO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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