Use of the xCELLigence System for Quantification of Bacterial Biofilm's Real Time Formation and A… (NCT03863249) | Clinical Trial Compass
CompletedPhase 4
Use of the xCELLigence System for Quantification of Bacterial Biofilm's Real Time Formation and Antibiotics Selection.
Spain64 participantsStarted 2019-02-08
Plain-language summary
The aim of the study is to develop an in vitro model of growth of oral biofilms, and validate xCELLigence system for the selection of an effective antibiotic treatment for each patient.
Who can participate
Age range
40 Years – 70 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
. Subjects of 40-70 years.
. No smokers or smokers of less than 10 cigarettes a day.
. Patients with periodontitis stages III and IV grades A-B.
. Presence of 20 natural teeth, including at least three molar teeth.
. Presence of at least 4 sites with at least 6 mm probing depth.
. Good general health
Exclusion criteria
. Smokers of more than 10 cigarettes a day.
. Patients who have received periodontal treatment in the previous 12 months.
. Patients who have used antibiotics in the last 6 months.
. Routine use of oral antiseptics and / or during the previous 3 months.
. Systemic conditions that required antibiotic premedication.
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
1
Clinical measure: Clinical attachment loss (CAL) change
Timeframe: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing).