CompletedNot Applicable

Interaction Between Immune Cells and Bacteria Associated With Periodontitis

Denmark90 participantsStarted 2017-02-01

Plain-language summary

This study evaluates the interaction between host immune cells and bacteria associated with periodontitis. It comprises biological material from donors with and without periodontal disease. Specifically, we collect a spit and blood sample to conduct in vitro stimulations and measurements of selected parameters related to periodontitis to clarify obscure areas in the immunologic pathogenesis of this disease.

Who can participate

Age range

19 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria for chronic periodontitis donors: * 50-60 years of age. * Interproximal attachment loss at minimum 3 teeth besides molars and incisors. * Clinical attachment loss at minimum 10 sites identified by bleeding and pus upon probing. * Visible radiographic bone loss. * Medically healthy donors. Inclusion criteria for aggressive periodontitis donors: * 19-40 years of age. * Interproximal attachment loss at minimum 3 teeth besides molars and incisors. * Clinical attachment loss at minimum 10 sites identified by bleeding and pus upon probing. * Visible radiographic bone loss. * Medically healthy donors. Inclusion criteria for healthy donors: (age: 19-40 years; 50-60 years) * No sign of inflammatory conditions or other general systemic diseases. * Medically healthy donors. Exclusion criteria for all groups: * Pregnant and breastfeeding. * Antibiotic treatment within 6 months. * Suffer from periodontal manifestations caused by systemic diseases e.i. genetic diseases, haematologic anomalies or syndromes.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

periodontitis-associated- and control bacterial stimulation of host immune cells.

Timeframe: Aug. 2020

Anti-cyclic citrullinated peptides (anti-CCP) antibodies titers.

Timeframe: Aug. 2020

P. gingivalis presence and related antibodies.

Timeframe: Aug. 2020

Single nucleotide polymorphism (SNP) analysis.

Timeframe: Aug. 2020

Trial details

NCT IDNCT03225950

SponsorUniversity of Copenhagen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-10-12

View on ClinicalTrials.gov More Periodontal Diseases trials

Plain-language summary

Who can participate

Age range

19 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

periodontitis-associated- and control bacterial stimulation of host immune cells.

Timeframe: Aug. 2020

Anti-cyclic citrullinated peptides (anti-CCP) antibodies titers.

Timeframe: Aug. 2020

P. gingivalis presence and related antibodies.

Timeframe: Aug. 2020

Single nucleotide polymorphism (SNP) analysis.

Timeframe: Aug. 2020