EUCTR2019-002239-27-ES
Active, not recruiting
Phase 1
Study on the relationship between periodontal disease and serum levels of ultrasensitive Reactive C-Protein and fibrinogen - PERIODONTITIS AND INFLAMMATORY MARKERS
Clinica Dental AndreuDental0 sites123 target enrollmentJuly 26, 2019
ConditionsPatients with a diagnosis of periodontitis: There is interdental LCI in two or more non-adjacent teeth, or two or more teeth have a vestibular LCI = 3 with a PD > 3 mmTherapeutic area: Diseases [C] - Mouth and tooth diseases [C07]
DrugsLIGOSAN
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with a diagnosis of periodontitis: There is interdental LCI in two or more non-adjacent teeth, or two or more teeth have a vestibular LCI = 3 with a PD > 3 mm
- Sponsor
- Clinica Dental AndreuDental
- Enrollment
- 123
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with a Probing Depth \> 3 mm in at least oneprobing site in two or more teeth
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 60
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 63
Exclusion Criteria
- •Patients who have total edentulism, have received periodontal treatment in the last year, there being a decrease in inflammatory activity, are pregnant or breastfeeding, given the
- •immunological tolerance during pregnancy, they are diagnosed of ulceronecrotizing gingivitis (NUG), being an acute process,
- •ulceronecrotizing periodontitis (NUP), being an acute process or diagnosed with HIV, due to the state of immunosuppression, recent
- •history of angina, myocardial infarction or CVA, since they suppose a confusion factor when elevating the serum levels of the biomarkers,
- •antecedents of acute inflammatory processes or recent traumatisms, suffer chronic ingestion of non\-steroidal anti\-inflammatory drugs
- •(NSAIDs) or glucocorticoids, decrease the immune and inflammatory response, have taken antibiotics in the last three months, since they decrease the inflammatory activity and therefore the serum levels of
- •biomarkers.
Outcomes
Primary Outcomes
Not specified
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